Health Care Review 2016

SMART GROWTH PUTTING THE PUZZLE SEEKING OUT MID-CAP STRATEGIES:
STRATEGIES: AN ITALIAN BACK TOGETHER THE NICHES THE DOMPÉ

TITAN REVEALS ALL PAGE 68 PAGE 39 EXPERIMENT
PAGE 10 PAGE 64
A TRADITION OF RESILIENCE
ITALY
page 21
AUGUST 2016
STRAP IN HERE PLEASE
ACKNOWLEDGEMENTS
Strapsubhead
Strap subheadininhere
hereplease
please
Acknowledgements
Pharmaboardroom would like to thank:
Beatrice Lorenzin, minister of health, Italy
Walter Ricciardi, president, national institute of health, Italy
Luca Pani, director general, AIFA, Italy
Massimo Scaccabarozzi, president, Farmindustria, Italy
Leonardo Vingiani, director, AssoBiotec, Italy
Gian Mario Baccalini, president, Aschimfarma
Enrique Hausermann, president, Assogenerici
Enrico Allievi, director, Assosalute, Italy
As well as all the companies we have met for their support,

assistance and enthusiasm.
2 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

STRAP IN HERE PREFACE
PLEASE
Preface
ITALY
Strap subhead in here please
Preface
Italy, considered by many to be the birthplace of
the modern pharmaceutical industry, has recov-
ered from its post-2008 economic slump and
returned to growth. This is due in large part to the
country’s strength in healthcare and life scienc-
es as global demand shifts from the low cost
pharmaceutical products produced in emerging
markets to those from higher quality European
sources.
However, whether this growth can be sustained
in the long-term is open for debate. Italy’s phar-
maceutical landscape is dominated by small- to
medium-sized companies, often family-owned,
and lacks a truly global giant to lead the industry.
Through in-depth interviews with the KOLs, CEOs,
government officials, and regulators shaping the
industry today, this report weighs up Italy’s pros-
pects and lifts the lid on its family-owned compa-
nies, the international prospects of its SMEs, the
move towards healthcare efficiency, and emerging
disruptive digital trends.
www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 3

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AMPLIFIED CONTENT IN BRIEF
JAAP HEUKERS – Managing @pharmaboardroom

Director, UPS Healthcare Italy Beiersdorf Italy a point of reference for the
region, placing strong emphasis on pharmacy
sector penetration
PAOLO ANDREATTA – CEO, Read the interview

E-Pharma Trento, Italy
@pharmaboardroom
Fabrizio Greco, GM @abbvie #Italy: 2015 was
excellent, we are becoming a #BigPharma
CHARLES-HENRI BODIN – company with a #biotech spirit
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Pharma, Italy Read the interview
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MARCO BERNA – Business Pharmaboardroom met Italy’s Minister of
Development Director, Gnosis, Health @bealorenzin at @SaluteDonnaMin,
Italy a day dedicated to women’s health.
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RAFFAELE STEFANELLI – CEO,
Stefano Folli on how @PhilipsItalia contributes
Boston Scientific Italy
to ensuring healthcare sustainability in Italy
Read the interview

HEALTHCARE & LIFE SCIENCES
REVIEW ITALY
Made in Italy
Feature
38
CONTENTS
— August 2016
2 ACKNOWLEDGEMENTS
3 PREFACE
A Tradition
6 SNAPSHOT IN FIGURES International Ranking
of Resilience
& R&D / Regional Focus & Export Growth
Cover story
21 8 ITALIAN TRADITIONS FEATURE
Family-owned companies
10 HOME-GROWN PIONEERS INTEVIEW
Alberto Chiesi, Chiesi
14 HEALTHCARE FEATURE Rethinking
provision models
17 DRIVING HEALTHCARE EFFICIENCY
INTERVIEW Giorgio Milesi, Johnson & Johnson
Medical EMEA
21 A TRADITION OF RESILIENCE COVER STORY
23 The sustainability conundrum
25 Generics: Playing Catch-up
28 Market Access: Faster than first appearances
Family Knows
Best! 32 The Mambo Italiano
Feature 33 Hospital-territoriality
8 35 To engage or not to engage?
36 Enabling Ecosystems
38 Made in Italy
39 Pharmaceutical Innovation: Seeking out the niches
43 Diabetes discombobulation
45 Standing at the precipice
46 Lifting the lid on nutraceuticals
46 Staying ahead of the game
49 A Virtuous Circle
The Healhcare & Life Sciences Review was produced
51 Branching out into consumer care
by PharmaBoardroom.
54 Effervescent innovation in Trento
Report Publisher: Mariuca Georgescu
Senior Editor: Louis Haynes 55 Closing the gaps
Editor: Patrick Burton
Project Directors: Alina Manac, Alexander Ackerman 60 EMERGING TRENDS FEATURE Digitalization
Project Coordinator: Lisa Diericks
Project Assistants: Laurent Pichotzki-Libano, Luis Sancho
64 MID-CAP STRATEGY INTERVIEW Eugenio
Graphic design: Carmen Reyes, Miriam León Aringhieri, Dompé
For exclusive interviews and more info, please log onto 68 CENTRALIZING HEALTHCARE POLICY
www.pharmaboardroom.com or write to contact@focusreports.net. FEATURE Collaboration
Copyright: All rights reserved. No part of this publication maybe reproduced in any 70 CONTRACT MANUFACTURING FEATURE
form or by any means, whether electronic, mechanical or otherwise including pho- Going Global
tocopying, recording or any information storage or retrieval system without prior
written consent of Focus Reports. While every attempt is made to ensure the accuracy 72 A CASE OF GROWTH INTERVIEW Dr. Massimo
of the information contained in this report, neither Focus Reports nor the authors
accept any liabilities forerrors and omissions. Opinions expressed in this report are Di Martino, Abiogen Pharma, Italy
not necessarily those of the authors.

SNAPSHOT IN FIGURES
International Ranking & R&D
ITALY IN THE INTERNATIONAL RANKING OF THE PHARMACEUTICAL INDUSTRY

PHARMACEUTICAL MARKETS IN ITALY
US
1st MANUFACTURING PLANTS
CHINA
2nd
3rd
JAPAN
GERMANY
174
4th
5th
BRAZIL EMPLOYEES
FRANCE
63,000
6th
7th UK
ITALY (90% GRADUATES)

8th
AND OTHER 65,000 IN UPSTREAM SECTORS
9th
CANADA
10th
RUSSIA MANUFACTURING VALUE
€29 BILLION
Below MEXICO SPAIN
Top 10
2005 2014 2018

OF WHICH 72% FOR EXPORT (€20.7 BILLIONS)
Population and economic growth are boosting demand for
HEALTHCARE IN EMERGING COUNTRIES. In advanced
economies cost containment measures are squeezing markets.
R&D EMPLOYEES
Source: IMS
DATA ON R&D INVESTMENTS IN ITALY

5,950
(% OF TOTAL)
Pharmaceutical INVESTMENTS
and health-oriented
Non profit biotech
Public R&D
3% 7%
€2.5 BILLION
OF WHICH €1.3 IN R&D AND €1.2 IN
HI-TECH PLANTS AND MACHINERY
43%
EXPORT GROWTH
46% +71%
IN THE LAST 5 YEARS COMPARED TO
+38% IN OVERALL MANUFACTURING
Internal R&D in
other sectors
Source: Elaboration of Istat data Source: Elaboration of Istat, Eurostat data

SNAPSHOT IN FIGURES
Regional Focus & Export Growth
PHARMACEUTICAL AND UPSTREAM SECTORS BY REGIONS
1 Lombardy 2 Veneto 8 Emilia Romagna

27,000 employees in 3,000 employees, 3,500 employees in pharmaceuticals.
pharmaceuticals. 7,000 in upstream industries (machinery,
chemicals, packaging) Parma: pharma ranks third for
1st for pharmaceutical
and biotech firms. export.
1
2 9 Marche
3 Piemont and Liguria
3
2,000 employees in 8 2,800 employees in pharmaceuticals
pharmaceuticals. 9 and upstream suppliers.
4
Ascoli Piceno: pharma accounts
10
4 Tuscany for 72% of total export.
5
6,000 employees in 11
pharmaceuticals. 6 10 Abruzzo
1,300 employees in pharmaceuticals
5 Lazio (100 in R&D)
1,300 in allied industry
15,000 employees in 7
pharmaceuticals.
11 Puglia
45% of regional export
(83% of hi-tech export) 3,000 employees in pharmaceuticals
7 Sicily and related industries.
1,000 employees in pharmaceuticals Centres of excellence of major
6 Campania 2,500 in related industries. international companies.
900 employees in Catania: pharma accounts for 16% of total Bari and Brindisi: pharma accounts
pharmaceuticals. export. for 28% of total export.
Source: Farmindustria, Osservatorio Pharmintech, Istat
MEDICINES EXPORT GROWTH 2010-2014

($ BILLION)
8.1 8.0 7.9 6.9 5.6 1.6

ITALY SWITZERLAND GERMANY DENMARK INDONESIA CHINA
0.5 0.3 -0.05 -0.5 -2.7

USA BRAZIL FRANCE SPAIN UK
Italy could be THE EUROPEAN PHARMACEUTICAL HUB with policies that make the country increasingly attractive to FDI
Source: Fondazione Edison on International Trade Center Data

ITALIAN TRADITIONS
FAMILY
KNOWS BEST!
Preface: Italy’s traditional family-owned pharmaceutical compa-
nies are one of its greatest strengths; but these companies must
be amenable to outside influence in order to grow sustainably.
“It is important to recognize that the back- opportunities to raise capital from PE or
bone of the Italian pharma industry is com- VC firms.”
posed of private, family owned companies,” CDMO Doppel is another example of
says PwC partner Rodrigue Schübelin. “This a private company that has opened equity
is actually a significant competitive advantage holding up to a private equity firm, although
in many regards, as these companies do not Doppel is not a family-owned organiza-
have to answer to shareholders every quarter tion.. CEO Giuseppe Casissi explains that
RODRIGUE and can act much more flexibly and decisive- “Doppel has played a critical role in devel-
SCHÜBELIN
ly than their public counterparts.” However, oping the [CDMO] industry’s culture, as for
PARTNER, PWC
he warns that “the risk is that without that many years it was the leading Italian-owned
pressure, some companies may not challenge CDMO in the country. In fact, our President
themselves to grow enough, or have a clear Mr. Paolo Lanfranchi, one of the company’s
idea of where they should invest.” three founders and CEO for many years,
SIFI’s executive chairman Fabrizio actually founded the CDMO group within
Chines argues that “first of all, when fam- Farmindustria and served as president for the
ily companies are growing in size, bringing first two terms.” Lanfranchi remains a share-
in outside management capabilities is an holder in Doppel, now holding 10 percent
absolute must.” Italy is already in a good of the firm’s equity, while PE firm Trilantic
position in this regard, as “it has become Capital Partners has a 90 percent interest and,
FABRIZIO CHINES
increasingly common for family owned with access to further capital, has ambitious
EXECUTIVE
CHAIRMAN, SIFI
companies to be run by non-family CEOs”. plans for expansion.
Instead, he argues that “the more relevant Third party healthcare logistic provid-
issue at present is not that of management, er Bomi Group, which already has a strong
but of investment capacity; some family international footprint, has taken a differ-
companies like Menarini and Angelini may ent route to raising equity capital by going
have the critical mass necessary to compete public via an IPO in June 2015. CFO and
effectively, but for others it is critical to con- VP Latin America Marco Ruini explains that
sider equity financing to support innovative “the plan behind the IPO was to establish a
product development or M&A strategies.” more substantial global footprint over two
SIFI is one such company that has “taken or three years” via M&A activity, and “for the
this step by securing equity funding from most part we plan to target our investments
THIBAUD
ECKENSCHWILLER a leading Italian PE firm, 21 Investimenti,” to strengthen our position in markets we are
VP AND MD, and Chines argues that there are other already in.” Beyond the capital made avail-
IPSEN “Italian companies [that] should look at able through the IPO, Ruini explains that

ITALIAN TRADITIONS
“going public has also added a lot of value saying that “making investments here is not
to our company, as we now have a larger and always straightforward, so the fact that we
more diverse board of directors who bring a are pushing ahead in such a strong way clear-
lot of experience from different industries. ly shows the potential we see for the country
The visibility we gained through the IPO is in this regard.” As such, it’s no surprise that
also a significant asset.” Identifying potential as an advisor to the industry, Schübelin is
targets is “one area where the IPO has brought increasingly “seeing companies looking for
us a lot of valuable experience,” according to help how to handle their liquidity, avoiding PAOLO
LANFRANCHI
Ruini, who says “finding a potential partner how to have too much cash on hand, not
CHAIRMAN,
or target for acquisition is difficult… the expe- being able to invest effectively due to the low DOPPEL
rienced voices that now sit on our board have interest rate environment and assistance in
helped Bomi management to keep our heads identifying potential targets for acquisition.”
cool, and to know that it’s important to take This, he points out, “has been more of an
our time before rushing into a commitment.” issue in recent years, and firms have increas-
As Ruini says, finding the right acquisition ingly struggled to find the right investment
target, or investment opportunity in general, opportunities.”
can be very difficult given current market con- However, just because there are a few exam-
ditions. PwC’s Schübelin observes that there ples of family companies opening up to out-
is “a lot of liquidity in the market, including side shareholders, the family business model
amongst the family businesses, some of which is not on the way out. Italian flagships like GIANLUIGI
FROZZI
are quite large and have as much as a billion Menarini, Chiesi and Zambon are still led by
CEO, ANGELINI
EUR on the balance sheet. This concentration family members alongside professional man-
of liquidity in the industry, which we see at agement. One such firm is Angelini, current-
the global level as well, has driven up prices ly led by CEO Gianluigi Frozzi who explains
of potential targets and now there are a lot of that “the family is very much involved in
companies looking for M&A opportunities the strategic direction of the business and
not able to find attractive targets.” Indeed it always looks out for the overall well-being of
does seem that nearly everyone is ‘looking for the company,” and says “the heritage of the
M&A opportunities’ alongside Bomi, includ- Angelini family is always present.” In fact, on
ing PE funds, big pharma, and even mid-cap the topic of the firm’s internationalization, he
players like Ipsen; Thibaud Eckenschwiller, declares “we aim to have a strong internation-
MARCO RUINI
VP and MD for Ipsen Italy, explains that al presence, but we still want to be perceived CFO AND VP LATIN
his company is “considering acquisitions in as a family business that meets the health-re- AMERICA BOMI
the primary care segment in the country,” lated needs of families around the globe.” GROUP

HOME-GROWN PIONEERS
SMART
GROWTH
STRATEGIES:
AN ITALIAN
TITAN
REVEALS ALL
Preface: The president of Chiesi explains how innova-
tion and a strong focus on quality have led to outstand-
ing growth and have established the Italian family-run
business as a significant pharma player around the
world. He furthermore elaborates on Chiesi’s strategy
to maintain growth abroad and reviews the challenge
of attracting and maintaining talent in Italy, identifying
the need for a public research funding agency to retain
Italian talent.
PBR: Mr. Chiesi, 2014 was a definitive year – 8.4

percent organic growth; EUR 1.34 billion in revenue
and being ranked as the 46th largest innovative phar-
ma company globally. Now that we are in March,
how have the results of 2015 been in comparison?
ALBERTO CHIESI (AC): In 2015 we achieved a total
turnover of EUR 1.467 billion (USD 1.627 billion),
which represents an increase of 9.4 percent compared
to the 2014 fiscal year. Approximately eighty percent of
turnover is generated by our operations abroad, which
makes us a truly italic-international company. This tre-
mendous growth was achieved organically without the
need for any acquisitions! Spread over our 26 affiliates
around the world, we employ over 4,500 people, and col-
laborate with approximately fifty different distributors
and marketers.
We made some significant progress in our respiratory
segment as our prime product Foster, which generated
EUR 500 million (USD 563.5 million) in sales in 2015,
proved to be very effective against asthma and chronic

HOME-GROWN PIONEERS
We strive towards globalization while maintaining our medium size…

this is actually not as paradoxical as it might seem… the idea is to go
global while all the time retaining the flexibility and attentiveness to
quality that a smaller entity enjoys!
obstructive pulmonary disease (COPD) enabling us to for COPD treatment, putting together a formula that
achieve and maintain 19 percent market share in Europe will even further improve the life of patients; and we
and become one of the leading players in this segment. hope to be the first to reach European approval for this
Another significant success was the approval of our unique combination.
innovative dry powder inhaler for Foster, which we suc- However, we have have recently reached a major mile-
cessfully launched in many European countries. Overall, stone, with the approval for our new regenerative prod-
the cumulative approvals for Foster was an achievement uct Holoclar. This product will stimulate the regeneration
of upmost significance to us as it allowed us to further of the cornea, the transparent area forming the front of
tailor and optimize our offering to doctors, thus helping the eye, which will help patients to regain vital eyesight,
the patients suffering from asthma and COPD. In this and is the first stem cell based product to be approved
core area, we are also working on the Triple combination in Europe!

HOME-GROWN PIONEERS
What’s holding back digital disruption is the question of ethical

handling of medical data… clear rules and regulations have to first
be put in place ensuring that this data is not misused
PBR: Much of your growth derives from the US & PBR: Italy has no pharma giant, however has de-
emerging markets. How are you coping with the re- livered numerous mid-sized champions such as Chi-
cent slowdown in these economies and where do you esi over the years. Given the current market condi-
predict future growth? tions, is there room to see another Chiesi grow?
AC : Europe will undoubtedly remain the AC: With the right innovative products and market ac-
main market for Chiesi. However, our overseas cess any company has the potential to rise in Italy. That
developments will reduce the European contribu- said, I don’t believe that our specific business model is
tion from approximately 60 percent to approximately easily replicated. Besides being research based, we strive
45 percent as our other divisions grow. The US is cur- towards globalization while maintaining a medium size.
rently the market we’re most focused on, although our This paradoxical message is easily explained: we want
current presence there is limited to special care and hos- to further focus on our here key segments—respiratory,
pital products. neonatology and rare diseases—and maintain a top po-
We have experienced the most growth in emerging sitioning in these segments on a global scale. To achieve
economies such as Russia, Turkey, China, and Brazil. the former, we have to focus our investments in those
However, promising emerging economies are though; research areas and strive for maximizing quality rather
development itself will pose a challenge these econo- than quantity. The idea is to be global whilst remain-
mies naturally evolve to drive an economic protectionist ing as flexible and quality focused as a medium sized
policy, usually raising local content requirements which company.
forces us to manufacture abroad.
PBR: You´ve witnessed many eras of the pharma
PBR: Looking at the US market, which is a very industry: the period of industrialization, the rise
challenging playground for many European phar- of the blockbusters and the trend towards interna-
maceutical companies, how are you consolidating tionalization. What do you identify as the new era
your position there? Are you considering organic of pharma?
or inorganic growth along the lines of Cornerstone AC: E-Healthcare will possibly herald a new era in
Therapeutics? the pharmaceutical industry. Applications could very
AC: A well balanced mix of organic and inorganic well enhance compliance and information transfer. In
growth will consolidate our position in the US market; we the respiratory segment for instance, electronic devic-
are currently considering some projects in our special care es could significantly enhance information transfer in
unit which would translate effectively to the US market. between patient and doctor, thus improving the thera-
Holoclar will be one of our pathways to steadying our US peutic effect on the patient. E-devices could gather sub-
presence, although it is a treatment and not a medicine, stantial information from patients that could possibly
which means if we want to market it in the US we need improve healthcare as a whole. That said, the challenge
to establish a biotechnology company to gain the ability in this innovative technology is the question of ethical
to manufacture domestically and thus comply with the handling of the data. Clear rules and regulations have
US regulatory framework. I identify significant potential to be put in place ensuring this data is not misused in
for acquisitions in the US start-up scene, which we will any way, and a solution to this challenge will not be
review carefully and seize when the opportunity arises. easily found.


HEALTHCARE
Rethinking provision models
TAKING COSTS
OUT OF
THE SYSTEM
Preface: Opportunities for savings abound within the
Italian healthcare system, provided investments are
made in centers of excellence, digital technology, and
new methods of data collection.
W
ith pharmaceuticals accounting
for under 15 percent of health-
care spending in Italy, and medical
devices between f ive and six
percent, there is far more opportunity for savings within
the healthcare system itself than through negotiations
with the life science industry. KPMG partner Alberto de
Negri explains that “we have so many areas we can do bet-
ter with less,” for example “by approaching hospitals of an We have so many
independent trust with a reasonable threshold of efficien-
areas we can do
cy set, we have found savings of EUR 2 billion.”
Significant gains in efficiency can be achieved through
better with less
reducing the spread of healthcare procedures across many
small facilities, and promoting their concentration with-
in centers of excellence. Giorgio Milesi, VP for Southern ALBERTO DE NEGRI PARTNER, KPMG
Europe at J&J Medical, explains that “at present, we have
hundreds of hospitals carrying out just a handful of care in healthcare facilities, and separately of the consum-
procedures of a given type per year,” while “studies have erization of healthcare into people’s homes via mobile
shown that there are significant improvements in efficacy health and home care solutions.” Within the context of
and safety of such procedures when carried out at a spe- healthcare facilities, Folli contends that “to make smart
cialist facility where at least 60 of said procedures are car- decisions in resource allocation, you need good informa-
ried out per year.” As such, he argues that it is “statistically tion; this means good quality data that is well analyzed
safer and more efficient when expertise and healthcare ser- to extract actionable information.” While, “a lot of data
vices are concentrated in centers of excellence. For patients is already collected and available in Italy, the collection of
there are benefits in terms of recovery time, less adverse this data is very fragmented” and “as such the inputs for
consequences, and shorter hospital stays, which are natu- data analytics techniques are not of great quality.” Most
rally also better for healthcare budgets.” importantly, information is not yet shared across devic-
Philips Italy CEO Stefano Folli believes that technology es and platforms in real time. Predictably, Folli concludes
can play a significant role in improving the efficiency of by saying that “Philips can help to collate, leverage, and
the healthcare system and organizes such opportunities analyze this data in a more rational fashion through our
“around two trends: the continuing industrialization of HealthSuite Digital Platform, and help actors to extract

HEALTHCARE
Rethinking provision models
reliable and actionable information to drive smart health-

care management decisions.”
Investing in improving data collection and manage-
ment within the Italian healthcare system could have sig-
nificant impacts on the medical device industry as well. EXTENDED PORTFOLIO OF
According to Luigi Boggio, president of Assobiomedica HEALTHCARE
and MD for B Braun, this is because at present Italy does
“not have any central way of measuring the cost and effec- SOLUTIONS
tiveness of our technology. We are missing a national sys-
tem to evaluate the benefits of our products, which is quite B. Braun is one of
the world‘s leading
frankly a nightmare, because regions are free to decide
providers of health-
whether any given medical device is beneficial for their care products today,
citizens.” While the Italian medicines agency AIFA exists supplying the global
healthcare market
to study the impact of innovative medicines, Italy lacks
with products and
no such authority to oversee valuing medical devices and systems for anest-
technologies, and Boggio says “the tendency is to assess hesia, intensive care,
innovation as an additional cost.” The association has cardiology, extracor-
poreal blood treat-
made some progress, as Boggio explains they have “had ment, and surgery,
long discussions with the Minister of Health, a roundtable as well as providing
with medical professionals, pharmacists, institutions and services for clinics,
physicians in private
the industry to find procedures with which we can meas- practices, and the
ure and evaluate the benefit of new technologies, which home care sector.
will ultimately influence reimbursement decisions.”

Imagine a world where no child suffers

from lack of access to safe surgery.
Since 1988 Johnson & Johnson
has partnered with the international
medical charity Operation Smile
which provides free surgical
procedures for children and young
adults born with cleft lip, cleft palate
and other facial deformities.
Transforming Lives,
One Smile at a Time
Every 3 minutes, a child is born with a cleft lip or cleft palate About Operation Smile
and may suffer from torments, malnourishment and difficulty Operation Smile is an international medical charity that has
with speech. It takes as little as 45 minutes to repair a cleft provided hundreds of thousands of free surgeries for children
lip and/or cleft palate. It is estimated that billions of people and young adults in developing countries who are born with
lack access to basic surgical care. Billions more lack access cleft lip, cleft palate or other facial deformities. It is one of the
to safe and well-timed surgery.1 Access to surgery through an oldest and largest volunteer-based organizations dedicated to
organization like Operation Smile can transform their futures. improving the health and lives of children worldwide through
access to surgical care. Since 1982, Operation Smile has
Johnson & Johnson has partnered with Operation Smile since developed expertise in mobilizing volunteer medical teams
1988, contributing nearly $25 million in financial and product to conduct surgical missions in resource-poor environments
© 2016 Johnson & Johnson Medical S.p.A.
donations to bring safe, effective and well-timed surgeries while adhering to the highest standards of care and safety.
to the most vulnerable in our world. Employees around the Operation Smile helps to fill the gap in providing access to safe,
world are engaging in voluntary, employee-driven fundraising well-timed surgeries by partnering with hospitals, governments
campaigns or are donating their time on medical missions. In and ministries of health, training local medical personnel, and
May 2015, the company committed $25 million in financial donating much-needed supplies and equipment to surgical sites
and product contributions to Operation Smile over the next around the world. Founded and based in Virginia, U.S., Operation
five years. Smile has extended its global reach to more than 60 countries
through its network of credentialed surgeons, pediatricians,
doctors, nurses, and student volunteers.
1. Source: http://www.operationsmile.org/surgery/global-need
DRIVING HEALTHCARE EFFICIENCY
Giorgio Milesi, Johnson & Johnson Medical EMEA
REVOLUTIONIZING
COMMERCIAL MODELS
IN SURGICAL CARE
Preface: Despite the already existing efficiencies in expenditure has decreased in absolute terms, not just
the Italian healthcare system, there is still significant as a percentage of GDP. These constraints have result-
room for improvement. Johnson & Johnson Medical ed in imposed price reductions, less emphasis being
Devices’ head for southern Europe discusses a placed on quality, restrictions to top quality prod-
number of opportunities where Johnson & Johnson ucts in many cases, and sometimes even reductions
Medical can help to improve healthcare quality while in patient access. Italy is among multiple European
reducing costs holistically. countries where patients have to wait up to a year for
elective and non-urgent procedures such as hernia
surgery.
The current outlook does not feature an immedi-
PBR: Given Italy’s current healthcare sustain- ate resolution of these challenges. According to the
ability concerns, what is your outlook on the figures diffused in April by the Ministry of Economy,
growth potential for the innovative medical de- GDP growth rates in Italy remain low, and between
vice industry, and what should be the industry’s four and five percent of Italy’s GDP currently goes to
priorities? paying off debt. As such, while the Italian healthcare
GIORGIO MILESI (GM): It is a critical moment system is already very efficient, with only nine percent
for the healthcare sector in Europe as a whole, as of GDP invested in healthcare between public and
healthcare expenditures, which have been under pres- private expenditures - two percentage points below
sure for more than a decade, have been significantly France and Germany - increasing the proportion of
limited since 2008 crisis. Government interventions GDP invested in healthcare will likely not be feasible.
in spending have been more substantial in southern Since the medical device industry is very depend-
Europe compared to the north, and apart from Greece, ent on one customer, the state, the economic situation
Italy is actually the only country where the healthcare has placed strong pressure on our industry to change.

Market access has become a primary challenge for made during and following the 2008 financial crisis
all organizations. Today, one of our most important have impacted the health of the Italian population.
functions is to ensure that policy makers understand
the importance of investing in healthcare and the PBR: Considering the unavoidable financial
returns and durable benefits said investments bring constraints, how is Johnson & Johnson Medical
to a society as a whole. In fact, at Johnson & Johnson working to help the Italian healthcare system to
Medical we have just created a new regionalized mar- deliver even better value for money to patients?
ket access structure, such that we have a market access GM: We have worked on a number of fronts to help
director for each region, or group of smaller regions, improve the quality and efficiency of healthcare in
who coordinates all of our activities with key insti- Italy, working with both regional health authorities
tutional stakeholders in the political and healthcare and hospital management to implement new and
administration sphere. more effective healthcare management strategies. We
This is a critical moment: the industry and public have developed a portfolio of added value services that
jointly communicate the importance of prioritizing will help hospitals to reduce inventories or increase
investment and spending in healthcare. While Italy efficiency thanks to fast track surgical pathways.
has long been ranked among the three or four coun-
tries with the longest life expectancy in the world, PBR: As regards your internal organization,
in 2015, according to the data recently diffused by can you describe your current go to market mod-
Italian National Institute of Statistics, the life expec- el and how does this compare to a more tradition-
tancy of Italians decreased for the first time since the al approach?
Second World War. This is a shocking and worrying GM: To improve our operational efficiency and pro-
signal regardless of how small the decrease, as life-ex- ductivity we have implemented a new go to market
pectancy follows long term trends. A decrease is the model here in Italy, which has been exported to and
result of decisions and actions taken a decade ago – in adopted in many other Johnson & Johnson Medical af-
fact, this is one of the very first signals of how changes filiates, and it is starting to become the industry norm.

PBR: How is Johnson & Johnson Medical

The life expectancy of Italians working to encourage a more efficient use of pub-
lic resources in Italy?
decreased for the first time
GM: A tangible and ver y emblematic example
since the Second World War relates to how we have allowed a number of hospi-
[…] this is one of the very first tals to almost eliminate the need to keep stock. For
signals of how changes made hospitals that we have long-term partnerships with,
during and following the 2008 we have provided a system to track the usage of our
financial crisis have impacted products in the operating room (OR): the products
the health of the Italian are marked with RFID tags, sensors detect when they
enter the OR, and automatically reorder new stock.
population
As items are replaced as soon as they are used, hospi-
tals only need to keep very little stock on hand. This
reduces the need for manual ordering of products
Previously, all medical device companies organized and the amount of working capital tied up in inven-
their marketing and sales forces around product tory. Moreover, the system we provide also tracks the
based business units. As such, multiple product spe- usage of products over time, giving hospitals better
cialists would visit a given surgeon, each promoting records of what is being used in a given procedure
a different product line that they might use in their and thus, better information with which to optimize
procedures. While these specialists were very knowl- resource allocation.
edgeable about their products because they visited A broader, less tangible area where we are working
surgeons across many specialties, they were less to reduce waste is by advocating for the concentra-
knowledgeable about specific procedures. This lim- tion of procedures within larger facilities. In fact, I
ited their ability to engage with surgeons on certain recently met the Minister of Health and we discussed
insights of how a particular product could impact a also about this issue. At present, we have hundreds of
given procedure. hospitals carrying out just a handful of procedures of
To reduce the duplication of efforts and transfer a given type per year. Clinical Evidences have shown
the focus of our strategy from our products to the that there are significant improvements in efficacy
needs of the surgeon, and by extension patient, we and safety of such procedures when carried out at
reorganized our teams around specialty areas. For a specialist facility where at least 60 of said proce-
instance, we created a group called ‘pelvic surgical dures are carried out per year. It is statistically saf-
care’ which caters to surgeons who work around the er and more efficient when expertise and healthcare
pelvis: proctologists, gynecologists, and urologists. services are concentrated in centers of excellence. For
This team brings all of the relevant products to these patients there are benefits in terms of recovery time,
practices, and sales representatives have significant less adverse consequences, and shorter hospital stays,
knowledge regarding how these products can be which are naturally also better for healthcare budg-
used. As a result the customer is only visited by one ets. From a policy maker point of view, we have seen
representative who serves as a single point of refer- some good progress in terms of reorganization of the
ence providing all of our products relative to their hospital system. For example, the region of Lazio has
area of expertise. This also encourages the develop- now established a directive that will not accredit hos-
ment of strong relationships between customers and pitals that do not carry out at least a certain number
our representatives. of colon procedures per year.

SANOFI, A GLOBAL LIFE SCIENCES COMPANY
Sanofi is a global life sciences company committed to improving

access to healthcare and supporting the people we serve
throughout the continuum of care. From prevention to treatment,
Sanofi transforms scientific innovation into healthcare solutions.

COVER STORY
A Tradition of Resilience
Italy
A TRADITION my through many a period of weakness. Fol-
lowing the period of volatility that followed
OF RESILIENCE the 2008 financial crisis, Italy entered a reces-
sion during 2011, seeing the economy con-
tract 4.9 percent from the beginning of 2012
Amongst the myriad globally recognized luxu- to the end of 2014. Meanwhile, the coun-
ry brands produced by the Italian fashion and try’s pharmaceutical production increased
automotive industries, another sector flour- by 38 percent from 2009 to 2014, driven by
ishes beneath the public radar. True to form a 71 percent increase in pharmaceutical ex-
as a national champion, Italy’s pharmaceutical ports, reaching EUR 20 (USD 26.6) billion
industry punches above its weight in many re- in exports and EUR 29 (USD 38.5) billion in
gards and has supported the national econo- total production.

COVER STORY
Right now we are regarded as the second

European hub for pharma and medical devices,
behind Germany… and actually we could easily
become the first
Beatrice Lorenzin, Minister for Health
BEATRICE LUCA PANI
LORENZIN
general director,
minister of health AIFA
As such, “commentaries over the last one-and-a-half industrial production [of pharmaceuticals] in Europe
years in the nation’s newspapers, economic studies and after Germany, but number one when ranked by [phar-
official central bank reports all attribute the return to ma] production per capita.”
growth this year to two core economic sectors,” accord- The success that the industry is currently experienc-
ing to Massimo Scaccabarozzi, president of the phar- ing began long before 2009. “The global pharmaceutical
ma industry association Farmindustria; “the automo- industry was born in Italy,” affirms Aldo Braca, presi-
tive and pharmaceutical industries.” Commensurate dent and CEO of the internationally renowned oncol-
with its role in helping the Italian economy return ogy CDMO, BSP. “Farmitalia Carlo Erba and Lepetit
to growth in 2015, Scaccabarozzi explains that the were among the first pioneering companies about eighty
Italian pharma industry is “second in the ranking for years ago. Unfortunately, they did not receive much
backing from the government, so were never able to
PARVANEH SADEGHI
flourish to their full potential. Nonetheless, these two
Laboratory technician
Research and development
Novo Nordisk
entities planted the initial seeds for many Italian firms
to develop into what they are today. Looking at the
history of large-scale global players, such as Pfizer and
Roche, many have been linked, in some way or another,
to these two foundational Italian companies.”
Owing to this remarkable heritage, Italy possesses a
wealth of experience in pharmaceutical production, a
strong culture of excellence in the field, and a strong
manufacturing base that has enabled the industry to
capitalize upon significant growth opportunities over
it takes an innovative the past seven years. As Minister of Health Beatrice
mindset to change Lorenzin states, “healthcare represents 12 percent of
diabetes our GDP and we are the second European hub, behind
Changing Diabetes® and the Apis bull logo are
registered trademarks of Novo Nordisk A/S
Novo Nordisk’s therapeutic proteins have been helping people Germany, in both the pharmaceutical and medical
with diabetes live longer, healthier lives since 1923. Today our
drive to innovate is stronger than ever as we continue to reach device sectors. We could easily become the first, beat-
for the ultimate goal: defeating diabetes.
ing the Germans.” Nevertheless, the Italian industry’s
Learn more about how we are changing diabetes at
novonordisk.com current position might just as easily be lost; as the
Follow us on
opportunities fuelling this current boom may be tran-
sient. These opportunities stem from an indefinite
shift in global demand away from low-cost pharmaceu-
tical products and from APIs originating in emerging
markets like India and China towards higher quality

COVER STORY
INNOVATION IS DEFINING LEADERSHIP OF THE SECTOR
Hospital Direct-to-Patient Distribution Retail Value Growth — CAGR

(MAT 12/2013 - MAT 12/2015)
GILEAD 100% 135%

NOVARTIS 60% 9% 31% 7%
PFIZER 57% 5% 38% 1%
SANOFI 33% 13% 54% 1%
ROCHE 73% 3% 24% 5%
J&J 66% 7% 27% 13%
MENARINI 1% 3% 96% 3%
GSK 43% 1% 56% 2%
MERCK&CO 53% 6%
41% 0%
BAYER 30%8% 62% 4%
Source: IMS Health IMFMFODPC.
European sources. At the same time, Italian manufac- THE SUSTAINABILITY CONUNDRUM
turers certainly face a reasonable cost profile relative to
German, French, and British companies; in part due to “Life expectancy has steadily increased in Italy
the weaker macroeconomic context. for many years, and as the bir thplace of the
However, without a true flagship global pharmaceu- Mediterranean diet, it has long been known as a
tical player to lead the industry, it is important to rec- country where people live long lives … this makes
ognize that the backbone of the Italian pharmaceutical Italy one of the oldest populations in the world,
industry today remains overwhelmingly composed of which brings with it a significant burden of chronic
small to medium sized, often still family-owned, com- disease,” says Stefano Folli, CEO of Philips in Italy.
panies. Osvaldo Ponchiroli, CEO of OP Pharma, con- A country which has long prided the universality
firms that, “it is true that there are a number of well- and quality of its public healthcare, Italy faces major
known Italian companies, which are family-owned, healthcare sustainability concerns, and significant
that have attained massive success.” He attributes this steps have been taken to contain costs. Such steps
to “in-depth, insider knowledge, accumulated over dec- have not been without downsides, as Giorgio Milesi,
ades and combined with a strong ingrained aptitude for VP for Southern Europe at J&J Medical, highlights,
strategic long-term vision.” “in 2015 the life expectancy of Italians decreased for

COVER STORY
the first time since WWII … In fact, this may be one

of very first signals of how changes made during and
following the 2008 financial crisis have impacted
the health of the Italian population.” Looking for-
ward, how can Italy protect the universal healthcare
system, maintaining its high quality standards and
ensuring its survival for the next generation? Folli’s STEFANO FOLLI WALTER MASSIMO
response is simple; “to meet Italy’s healthcare needs, RICCIARDI SCACCABAROZZI
CEO, Philips Italy,
the Italian healthcare system will have to learn to do Israel & Greece president, ISS president,
Farmindustria
more with less.”
Analogous to EU states, the Italian government is
deeply concerned about the long-term sustainabili- population with 21.25 percent of Italians over the age of
ty of healthcare spending and maintaining universal 65 in 2014, behind only Japan and Germany.
healthcare coverage; “hospital pharmaceutical spend- Yet, thus far, the Italian government has actually
ing is EUR 1.8 (USD 2.0) billion out of control” warns proven to be highly successful at managing costs,
Minister of Health Beatrice Lorenzin. Concerns that with public healthcare spending accounting for
this number may be driven upwards are well founded, 7.1 percent of GDP versus the 7.9 percent average
given the large number of high-cost innovative thera- of the ‘Big Five’ EU countries, and pharmaceutical
pies that have recently or will soon be coming to mar- expenditures as a proportion of GDP are rough-
ket, as well as the fact that Italy already has an ageing ly 30 percent below that of France and Germany
We enable people
with life-altering
conditions to lead
better lives.
As leaders in the development and
marketing of orphan drugs for genetic
diseases, Shire brings hope to those
with rare conditions.
Cody and Kolten, living with Gaucher disease IT/C-APROM/CORP/16/0005 shire.com

COVER STORY
Generics: Playing Catch-up

MANLIO 2012 with the introduction of the of a big deal,” says Ferring Italy
FLORENZANO Balducci law, which Hauserman CEO Paolo Zambonardi, but
—
country head and
explains, “obliged prescription of “nowadays, the moment a patent
managing director, acute therapies according to in- reaches expiry you can expect a
Sandoz ternational non-proprietary names price decrease of 30 percent mi-
(INNs), as well as for cardiovascu- nimum.”
lar therapies for new patients.” Sandoz’s Manlio Florenzano
Partly due to this policy, retail sa- explains that there are a number
Why is generics penetration so les of unbranded generics in Italy of reasons that “the substitu-
low in Italy? Enrique Hauserman, registered an expansion of 12.1 tion-logic that works well in many
CEO of Eurogenerici (a subsidiary percent per annum from 2009 to European markets has clearly
of STADA), explains that “the root 2014, despite a 2.2 percent con- been less effective in Italy… First-
cause of this situation was the traction of the retail market for ly, the legislation tends to treat
system which was introduced in reimbursable products over that former originators and generics
2001, which did not take into con- same time period. in very much the same way. When
sideration the penetration time That said, generics penetra- a patent expires, we negotiate
for new generics, and caused ge- tion remains abnormally low, with the price with AIFA and then in-
nerics companies in the market to unbranded generics accounting novative companies tend to drop
compete against each other. The- for only 26.5 percent of off-patent their prices accordingly to the
re was also no incentive for pres- drugs sold in 2014 (by volume); point where the substitution logic
cribers or pharmacists to pres- additionally, 85 percent of the loses its relevance... It’s therefore
cribe generics.” IMS managing generics market continues to be quite easy to get sucked into a
director Sergio Liberatore adds controlled by just five companies race to the bottom on pricing.”
that “the patent cliff arrived with according to Hauserman; Doc Ge- Giving the other reasons, Libe-
a lag-time of two to three years nerici being the only Italian firm ratore says that “Italians remain
in Italy as the patent protection among this group. That said, while very brand conscious and phar-
legislation was introduced rather generics companies may have re- macists are obliged by law to ask
later than in many other coun- latively low market share in Italy, customers to choose between
tries,” and as such the generics their presence on the market has either the branded originator
segment “is still playing catch-up an undoubtedly greater effect to- or a generic. The difference in
comparatively with other mature day than previously. “In the past, price is then borne by the custo-
European economies in terms of when there was less competition mer, but in many instances this
penetration and market value.” to be faced down from generics, is a price that consumers prove
Generics policy was updated in patent expiry was not so much willing to pay.”
according to Farmindustria. Bloomberg actually you get to EUR 13 (USD 14.4) billion,” which is quite
rated the Italian healthcare system the third most comparable to the country’s EUR 15 (USD 16.6) billion
efficient in the world in 2014, giving the country an RX market, which has contracted significantly from a
‘efficiency score’ of 76.3; Singapore was rated the peak of EUR 17.2 (USD 22.8) billion in 2010 (IMS data).
most efficient country with a score of 78.6, while in Prices have similarly fallen, with an average pack costing
eighth position France was the next most efficient EUR 9.6 (USD 10.7) in 2015 versus EUR 11.4 (USD 15.1)
European country, with a score of 64.6. in 2010. Given these trends and the pharma industry’s
As such, Massimo Scaccabarozzi, president of economic contribution to the country, many indus-
Farmindustria, has been working to communicate that try leaders have argued that the government should
“if you add up what [the pharmaceutical industry] gives stop framing the pharmaceutical industry purely as
back in terms of investments, R&D, salaries, and taxes a cost to be contained, with Pfizer country manager

COVER STORY
Massimo Visentin saying, “there needs to be a broad-

er shift in attitude towards viewing pharmaceuticals
as part of the solution, rather than purely as a cost.”
Scaccabarrozi has been central to encouraging this shift
in perspective, and he contends that “we have succeeded
in changing the government’s perception of the industry,
and a clear indication of that came in October 2014 when
we had a meeting with the Prime Minister… We invited all LEONARDO FRANCESCO FABIO ANDREOLA
VINGIANI DI MARCO
the CEOs of the major national and international com- country managing
director, managing director, director, Baxalta
panies investing in the country to this meeting, we met
Assobiotec Amgen
with the Prime Minister, and we made a pact to invest in
the country. In return, the government would view the
industry not just as a cost, but as an asset to the country.” of the most innovative and expensive new drugs.” Here
Despite improving industrial relations between the there is a clear limit to the amount the government is
industry and government; many feel that the funding willing to spend, and it is far below the real demand.
committed by the government for pharmaceutical spend- “This gap currently stands at around EUR 1.5 (USD 1.7)
ing is insufficient. Pfizer’s Massimo Visentin argues that, billion and, considering the fact that the total budget is
“the system today is certainly not sustainable, in particu- currently EUR 3.8 (USD 4.2) billion, this demonstrates
lar when you isolate the hospital business which is seeing, that the budget is simply not matching the country’s
and will continue to see, the introduction of the majority needs,” he observes.

COVER STORY
GENERICS TRIGGER DECLINES IN THE PRESCRIPTION RETAIL MARKET

NEW CHEMICAL ENTITIES (NCES) OFTEN RESTRICTED TO NON-RETAIL CHANNELS
RX Retail Market (USD billion) Av. Price RX products per pack (USD)
19.6 19.7
18.9 18.9
17.6 17.6 17.1 17.1
13.3 13.2 13 12.4 11.6 11.4 11.1 10.9
-17% vs 2008
2008 2009 2010 2011 2012 2013 2014 2015
Source: IMS Health – Multichannel 2015 – Public prices.
The situation is further complicated by the fact that government is working to meet budgetary targets, “it
Italy has “silo budgets in healthcare, which means is very difficult to close a hospital while it is much eas-
that whatever is saved in hospitals cannot be redirect- ier to introduce measures such as our current payback
ed towards the pharmaceutical sector,” according to system where we pay back around 50 percent of the
the general manager of Amgen, Francesco di Marco. budget overruns incurred as a result of overspending.
As such, he says that while “it is true that highly effec- Unfortunately, this does not only put a cap on the sys-
tive drugs do generate savings in the hospital sector, tem’s expenditures, but also on innovation, as well as
unfortunately Italy’s healthcare system is not currently to patients’ access to it.”
structured in such a way as to be able to take advan-
tage of this.” Leo Pharma’s general manager Paolo
Cionini, for his part, notes that, “different regulatory
authorities have different budgets and concerns. For
instance, AIFA is only responsible for pharma prod-
ucts, so they focus on drug prices. But there are inter-
actions between all elements of the healthcare system,
for instance, an efficient drug may lower hospitaliza-
tion costs, and this needs to be taken into account in
EUGENIO PAOLO PAOLO CIONINI
the drug pricing and reimbursement process.” Marco ARINGHIERI ZAMBONARDI
managing director,
further points out that the nature of hospital and Leo Pharma
CEO, Dompe managing director,
pharmaceutical costs are very different and, when the Ferring

COVER STORY
Market Access: Faster than first appearances
FRANCESCO diseases. Obviously cost-control is tion.” However, he warns that “in

SCOPESI a priority for state actors, but we actuality many individuals within
— are always able to identify points the public sector remain focused
managing
of convergence and they do prove on minimizing costs, which can
director, Shire
receptive in understanding the be- make it a challenge to effectively
nefits we can deliver to patients.” validate and communicate the va-
Moreover, the authorities have ge- lue of the innovative therapies we
nerally supported Shire’s pionee- offer.” As such, companies com-
Shire’s Francesco Scopesi has a ring efforts in the area of home mercializing orphan drugs “must
rare insight into many aspects care and, starting in 2008, Shire be able to demonstrate the value
of the Italian healthcare system. initiated a home delivery program that their products bring to pa-
“In spite of some of the lowest for “enzyme replacement thera- tients and the healthcare system
prices in the entire region,” Sco- pies in [Fabry’s] patients’ own ho- in a highly credible and transpa-
pesi says Italy’s “health system is mes rather than requiring them to rent way,” to assure market access
actually highly advanced.” While travel hundreds of kilometers to a discussions progress as rapidly
formal marketing and reimburse- specialist hospital every couple of as possible to limit “delays [that]
ment processes may take more weeks.” Scopesi adds that, “over come at a significant and avoida-
time than in other European coun- time we have scaled up the pro- ble cost to patient wellbeing.”
tries, he points out that “there are gram to include Gaucher disease However, VP and general ma-
laws in place enabling access to patients and even introduced a nager for Celgene, Pascale Fre-
a product prior to official appro- ‘follow-me’ aspect so that pa- ga, highlights the current role of
val status under regulations 326 tients travelling abroad in certain patient groups in Italy and exp-
and 648, which mean that you can other European countries such as lains that “the Italian system is
respond to unmet needs earlier Germany can receive their infu- quite limiting in the way it allows
than you might think, just so long sions abroad from a third party. companies to work with patient
as the product and patients satis- As you imagine, these sorts of ini- groups… there is still a very limi-
fy certain conditions. This means tiatives transform lives and greatly ted role for patient associations
that, when there is a pronounced enhance patient satisfaction.” in the decision-making process.”
medical need that is recognized, Fabio Andreola, country mana- This is a particular issue for pa-
then the Italian system is capable ging director at Baxalta concurs, tients with rare diseases, as
of delivering. There are thus some saying “overall, Italy treats rare in such situations they often
very appealing characteristics that diseases very well, and patients become more knowledgeable
the medical community very much have good access to orphan drugs about their particular condition
appreciates.” relative to most other countries, than many of their physicians.
As a key stakeholder in the ma- and moreover “in principle, all As such, Frega hopes that “the
nagement of a number of rare di- stakeholders in Italian healthcare - government changes the way in
seases, Scopesi says that in his ex- from centralized authorities to re- which it approaches patient as-
perience “the authorities, for their gional institutions - are aligned on sociations and includes them
part, constitute a reliable partner the fact that rare diseases and or- more prominently in the deci-
that is sensitive to the issue of rare phan drugs require special atten- sion-making process.”
The payback system to which Marco refers has behind the government trying to contain costs and bring
become a significant bone of contention between the health expenditure under control, but notes that “this
pharmaceutical industry and the government, and now mechanism where we pay for part of the expenditure
ranks as a major consideration for potential investors. naturally makes us think long and hard about continu-
Boehringer Ingelheim’s country president Anna Maria ing to invest in the country.” “If we have to repay a cer-
Porrini says that she “can understand” the rationale tain amount of money, that means that we cannot use

COVER STORY
WE CARE
FOR THOSE
WHO CARE,
IMAGINE CARE
AND RECEIVE
CARE.
WWW.ABIOGEN.IT BRINGING TREATMENT

WWW.ABIOGEN.IT
UN’AZIENDA SANA PER UN PAESE CLOSER PIÙ SANO.
Healthcare & Life Sciences Review: Italy 29
COVER STORY
Heterogeneity has proliferated,

resulting in a wildly imbalanced
public health landscape with
certain regions blessed with world-
class care, while others languish
blighted by dysfunction
ENRIQUE MASSIMILIANO FEDERICO SEGHI
HÄUSERMANN ROCCHI RECLI Walter Ricciardi, president of the Italian
president, Euro managing director, managing National Institute of Health (ISS)
Generici (Stada) Accord Healthcare director, Molteni
that money to invest. This is quickly becoming a vicious These savings would however go to consumers and would
cycle, which we feel must be broken soon,” she adds. not directly impact public budgets. Generics and biosimi-
Pfizer’s Visentin recalls that working with the govern- lar penetration in hospital channels may lag behind some
ment to find new solutions has become a key priority, so other European markets, but Accord’s managing direc-
much so that a there was a “meeting between our CEO, tor Massimiliano Rocchi explains that for the “tradition-
Ian Read, and Prime Minister Renzi and Minister Lorenzin al chemotherapies, the market-share in terms of volume
last September, in which he discussed the need to find an varies from 60 percent for Epirubicin to 100 percent for
alternative to the current payback mechanism that places fluorouracil. All the rest fall somewhere in this range,” and
the country in such an unfavourable position compared to for the hospital market in general “volumes and consump-
other more competitive European markets.” tion are flat and the price is declining due to competition.”
Given the relatively scarcity of public funding for phar- He further explains that “today, the adjudication process
maceuticals when compared to the other big five EU [for tenders] is one hundred percent based around price,”
countries, many innovative stakeholders have actually but that this should be changing as EU directive 24/2014
come round to encouraging the use of generics and bio- “states that hospitals should change this to be compliant
similars, which retain a relatively low penetration, account- with the ‘Most Economically Advantageous Tender’ pro-
ing for only 20 percent of market value and 50 percent of. cess,” which will theoretically encourage hospitals to offer
Leonardo Vingiani, director of Assobiotec, argues that, “it the best value offer, not the lowest price.
is vital that we save money through generics, in order to Of course, given the unsustainability and cost of
finance innovation [and] without these savings, we will remaining attached to branded products, the situation is
not be able to innovate sufficiently to effectively maintain evolving. Osvaldo Ponchiroli, CEO of OP Pharma, notes
our traditional standards of healthcare.” Novartis’s global that “the Italian generics market has seen double-digit
strategy corresponds directly with Vingiani’s argument. As growth in the past decade… [and] this growth is set to con-
Novartis country president Georg Schroeckenfuchs points tinue. Generics penetration is still low in Italy compared
out, his company offers “high quality generics through to other European countries, and given the unrelenting
Sandoz and leadership in biosimilars as well. This allows budget constraints, the generics market will only con-
us to contribute proactively to the establishment of an tinue to grow, as these drugs represent a critical element
overall more sustainable healthcare system. The generics of the solution to the problem of maintaining budget
and biosimilars that we provide can go towards freeing up sustainability.”
resources that can then be reinvested in real innovation.” Unfortunately, Italy’s attachment to original phar-
According to a study commissioned by Assogenerici, maceutical products is not the only inefficient behavior
as much as EUR 1.4 (USD 1.6) billion in retail spending encountered within the healthcare sector. For one, there
could be saved through the wider use of generics in Italy. is significant room for improvement in preventative

COVER STORY
healthcare; according to MSD Italy’s CEO Nicoletta on the state of

Luppi, “the WHO has been very severe with Italy, as cov- the healthcare
erage among the population is falling rapidly.” For MSD, system, and so
she says, “our first objective therefore needs to be to help provide decision
the authorities to get coverage rates up to the required makers with
standard. Approval of the National Vaccination Plan is the appropriate
the best way to do this, especially considering its relatively tools to make
low expense compared to the large costs which could be smart decisions.” OSVALDO NICOLETTA LUPPI
avoided through its effective implementation.” In essence, the PONCHIROLI
managing director,
CEO, OP Pharma MSD
Professor Walter Ricciardi, president of the Italian pharmaceuti-
National Institute of Health (ISS), highlights that, in the cal industry has
battle for managing costs in healthcare, one of Italy’s great- made clear progress in cutting costs of innovative drugs in
est assets is not being fully utilized. As he explains, much recent years, with total RX expenditures actually decreas-
like the budgetary situation, “the data we provide is being ing. As Pfizer’s Visentin puts it “saving in pharmaceuticals
used in silos, so the Ministry of Finance is using our finan- while hospital sector costs continue to spiral out of con-
cial data, while the Ministry of Health is using the data on trol will not be sustainable, or correct.” That said, Italy
healthcare indicators.” As such, while the ISS has “plenty clearly possesses the tools needed to improve operational
of data, our system is severely underestimated, underval- efficiency within the national healthcare system, and cur-
ued and underused,” and he asserts that “we need to start rent healthcare spending efficiency is already respectable
breaking down these silos in order to gain new insights relative to other European countries.
BIOPHARMA
Integration of microbial fermentation with h ad
dvanced chemical
synthesis and purification for serving highly complex API manufac
cturing
g

COVER STORY
THE MAMBO ITALIANO institution.” A sensible and eye-catch-

ing model that “differentiates the
Part of the prestige attached to the Italian regulatory apparatus from its
“made in Italy” brand stems from the equivalent European counterparts.”
sheer level of creativity and attention For Pani, this “ability to fully nego-
to detail that Italian workmanship tiate the national registration for a
usually exhibits. End consumers may drug ‘under one roof ’ has become SERGIO MASSIMO
not have reason to wonder where this a real asset, rendering AIFA the sole LIBERATORE VISENTIN
lauded Italian flexibility and creativi- negotiator for public reimburse- managing managing
director, IMS director, Pfizer
ty derives from, but those more famil- ment.” Unfortunately, the situation Health
iar with the country witness a cul- is not quite that simple. As Ferring
ture that prides elaborately creative, Italy’s CEO Paolo Zambonardi to two years. Zambonardi concludes
intricate, and sometimes convoluted details, “right now, once approval is “the end result is a loss of approxi-
methods over a simpler path. secured from the EMA, it takes a fur- mately two years patent and today
The Italian market access scenario ther six to nine months to get a deci- that results in big damage to your
for pharmaceutical products provides sion of pricing at the national level profit margins but, more important-
a fitting example. Pani recounts that before then going to the 21 different ly, it is a problem for the patients who
AIFA “was originally established with regions each with their own peculiar- do not have access to innovative prod-
the idea of calculating the risk-ben- ities and distinctive health systems.” ucts to treat their diseases while they
efit and benefit-to-price ratios of Some regions are faster than others, wait.”
new drugs within the very same ranging from a matter of weeks up The ISS’ Walter Ricciadi explains
that this anomalous situation arose
out of ill-thought-out modifications
to the national constitution back
in 2001. “Essentially, the provision
of healthcare was delegated to the
country’s 19 regions and two auton-
omous provinces, and the state did
not retain sufficient competencies to
maintain a homogeneous, effective
and efficient system in the country.”
Instead, as Ricciardi puts it, “heter-
ogeneity proliferated, resulting in
a wildly imbalanced public health
landscape with certain regions bless-
ed with world-class care, while others
languish blighted by dysfunction.” In
his eyes, “the only way to ensure the
country’s continued ability to main-
tain universal coverage is to refashion
the governance model.” Such an even-
tuality may soon reach fruition with
constitutional amendments already
under discussion to that effect in the
parliament, which would ultimately
Molteni ADVHealthcare
32 2016.indd 1 & Life Sciences Review: Italy 24/02/16 15:23 www.pharmaboardroom.com
COVER STORY
Hospital-territoriality
Excerpt from interview with Gabriele Baccelli, country manager for Orion Italy
management that it was possible tory sector for example your main
to operate effectively and profi- competence is to find the time
tably using a heterogeneous stra- and the people to get as much
tegy, as long as we had the right contact as you can. This is because
team to implement it. in these crowded markets the only
Right now, our customers are added value is contact. That is not
not only taking care of patients, true for the hospital market, and
they also need to organize their it is why many companies which
department, manage budgets, tried to face the hospital and terri-
reorganize their operations on tory market with the same strate-
the territories and perform many gy failed utterly.
GABRIELE BACCELLI other tasks. This means it is im- Now, in two years we have
— portant to not only communica- completed 75 percent of the ro-
country manager, Orion Pharma te the value of the drug directly, llout of our drugs to the Italian
but also to talk about the patients regions which means that in some
“In Italy if you want to be active they are managing and how they hospitals the patient has had ac-
in the hospital market, you need do this. If in that environment you cess to our drugs for almost two
to know the territory very well. We can show that your drugs are sus- years and in some other hospitals
have 20 different regions, with 20 tainable and add value to the en- they are not yet available. Stake-
independent healthcare systems, tire organization, rather than only holders need to come together to
and this is different to what Nor- the patient and the customer in an improve the regulatory environ-
dic companies are used to. Here in isolated fashion, you can succeed. ment, to make the quality of heal-
Italy everything can be completely This is what makes the hospital thcare more homogenous. This
different from hospital to hospital market completely different from will be to the benefit of both our
so we had to communicate to our the territory market. In the respira- patients and the industry.”
require ratification by referendum seventh largest pharmaceutical mar- Germany, Spain and Italy.” Falciai
later in the year. ket worldwide, IMS Italy is in fact the notes that “Italy is one of the most
IMS managing director Sergio third ranked affiliate within the IMS challenging countries for market
Liberatore has another perspective global organization. access policy,” but contends “AIFA
on the complexity of the Italian phar- Given the fact that getting market has made important improvements;
maceutical market. As he explains, access for a product nationwide can the timing for centralized approved
“the entire marketplace is much require 20 sets of negotiations, one drugs is much faster now. If you want
more granulated than in many coun- with each of AIFA and the 19 region- to have reim-
tries,” and is served by 240 whole- al authorities, foreign companies bursement, it
salers alongside direct sales between must enter the market with a care- naturally takes
some pharmaceutical companies ful approach. Simona Falciai, gen- longer to go
and pharmacies, “and that translates eral manager for Shionogi’s recently through the
into a high demand for connect- established Italian affiliate explains reimbursement
ing up the dots, which happens to that the company started building process, but the
be our specialty.” Liberatore admits their European “base in 2012, pri- timelines for
that “the complexity of the Italian marily focusing on developing and reimbursement SIMONA FALCIAI
marketplace creates a lot of work for registering innovative medicines for have also been general manager,
us,” and as such, while Italy has the the European market, focusing on shortened from Shionogi

COVER STORY
roughly over a year to six to nine

months nowadays. I think a remain-
ing challenge is the predominate
regionalization in Italy.” With these
remaining challenges, Falciai says
that “we will focus on women’s health
in the first few years of our presence
while working on the clinical research ANTONINO REALE PAOLO CASATI
and market access strategy for our managing director, managing director,
Daiichi Sankyo Santen
new specialist pipeline,” including
one very promising product that
Shionogi expects “to launch in 2020, the ophthalmology niche, Casati will
but we need to start now with our begin “looking at the introduction
market access strategy to understand of a wider, more diversified portfolio
what will be required from the payers over time.”
in order to get optimal access to this Although Daiichi Sankyo has had
drug.” an established presence in the Italian
Another Japanese company, oph- market for several years, Antonio
thalmology specialist Santen, is in a Reale, the CEO of the Italian affiliate,
similar position with regards to their has also had reason to refocus the
entry into Italy. General manager organization as the company’s global
Paolo Casati explains that “Santen R&D focus has recently shifted from
entered the Italian market being primary care to specialty care, with
entirely focused on glaucoma,” and the first such innovative product,
the company will be “expanding our Edoxaban, expected to launch very
portfolio in a smart way,” by first soon. Reale explains that due to this
building “a strong portfolio in oph- shift, “we decided in 2013 to move
thalmic pharmaceuticals as a foun- away from the traditional “push”
dation for the affiliate.” This strategy marketing model to a “pull” model,
is “especially relevant as we have four driven by the needs of our stakehold-
new ophthalmic treatments arriving ers. Specifically, it meant switching
over the next few years, and three of from a largely tactical approach to a
those address unmet needs.” As such, strategic mind-set and to implement
Casati is “working to establish the a new, more agile and flexible struc-
brand of Santen” in Italy as “one of ture better able to respond quickly to
the very top companies of reference all the external changes and challeng-
in our area… especially in terms of es.” According to Reale, the key aspect
relationships with KOLs and the of this transformation “was the deci-
scientific community,” although it’s sion to build the new market access
clear that the global brand is already team from the ground up,” and to
known in Italy as “a customer sur- focus “on attracting and recruiting
vey showed that most of the KOLs in capable resources from the outside”
Italy knew Santen before we arrived for these roles, because the organi-
in the market.” Once Santen Italy zation “desperately needed to obtain
establishes itself as a key player in expertise in this new area.”

COVER STORY
TO ENGAGE OR NOT TO ENGAGE?

Other factors influencing companies’ go-to-market and
stakeholder engagement models include significant
downward pressure on prices, increasing demands for
real world data and robust pharmacoeconomic stud-
ies, and of course global trends around patient-centrici-
Our future
ty, digitalization, and global health. Significant changes is all about you
have already been made to adapt to market conditions,
and Alexander Zehnder, president and MD of Sanofi,
explains that “the future is going to be about deploying
much smaller, specialized, and medically prepared sales
forces, while enlarging the internal expertise in market
access and governmental affairs. Within Sanofi we are
already well underway reconfiguring our teams to reflect
emerging realities. In the past couple of years, we have
more than doubled our market access and government
affairs departments by bringing in capabilities.” In a sim-
ilar vein, J&J Medical has reconfigured their organization
and “created a new regionalized market access structure,
such that we have a market access director for each region,
or group of smaller regions, who coordinate all of our
activities with institutional stakeholders in the political World-class
and healthcare administration sphere,” according to J&J hormonal contraception
Medical’s VP for southern Europe Giorgio Milesi. These
activities range from public and professional educational 100 years experience
programs, to initiatives to eliminate the need for hospi- in hormon manufacturing
tals to maintain significant inventories, and a variety of
campaigns to help reduce holistic treatment costs of tar-
geted pathologies, alongside pricing and reimbursement Continously expanding
discussions.
product range
On another front, under pressure to accommodate
price reductions Milesi has “implemented a new go to
market model here in Italy,” which has helped J&J Medical
in “improving efficiency and facilitating a cut in prices.” Delivering quality therapy
This new model brings the concept of patient-centricity
into surgical equipment portfolios, as Milesi explains that
through generations
“previously, all medical device companies organized their
marketing and sales forces around product based business
units. As such, multiple product specialists would visit a
given surgeon, each promoting a different product line
that they might use in their procedures… To reduce the
duplication of efforts and transfer the focus of our strate-
gy from our products to the needs of the surgeon, and by
extension patient, we reorganized our teams around spe- www.gedeonrichter.it
cialty areas.” Aside from improving efficiency by reducing

COVER STORY
the number of other European affiliates have. He provides the example

visits made to a that “two of our most important products concerning
given surgeon, functional urology, which are reimbursed in Europe’s oth-
representatives er main countries, are not reimbursed in Italy,” saying that
specialized in a “this immediately puts us on a different scale in terms of
given therapeu- possibilities for growth.” However, Buratti does highlight
tic area rather certain positive aspects to the situation, based on the fact
FABRIZIO CHINES MARCO RUINI than around a that the Italian affiliate has “had to develop very different
executive VP CFO & LATAM, product line are methods of managing the pricing and reimbursement pro-
chairman, SIFI Bomi Group
able to develop cesses for the approval of new drugs.” He explains that “I
specific knowl- had never previously heard of a pay-by-use system for the
edge regarding common procedures in that specialty, and reimbursement of a drug,” yet it seems “that in the future,
thus better “engage with surgeons on certain insights of these processes which the country has developed will be
how a particular product could impact a given procedure.” adopted on a more global scale; so despite the fact that we,
This model, first developed in Italy, “has been exported to as an affiliate, are suffering right now due to not being able
and adopted in many other J&J affiliates – and is starting to obtain the best price for our products, our experience
to become the industry norm,” according to Milesi. with the system in Italy can make our group aware, at a
Still, the blunt reality is that, as Astellas’s former gen- global level, of possible future approaches to pricing and
eral manager Ermano Buratti puts it, “our system in Italy reimbursement.”
does not, in many respects, afford us the same possibilities
NUMBER OF CLINICAL TRIALS ENABLING ECOSYSTEMS

IN ITALY
For their part, the national government is aware that
Phase I and II Other there is much they can do improve relations with the
life sciences industry, one of the best performing sectors
800 throughout the recession, and already significant efforts
have been made in this regard. Walter Ricciardi, president
700 of the Italian National Institute of Health (ISS), admits
that Italy has “had difficulties in the past in creating the
600 right eco-system for attracting investment, and one of
the issues standing in the way of that is our bureaucra-
500
cy.” Ricciardi says that “we are aware that our bureaucra-
cy is one of the worst,” and that while such bureaucracy
400
has helped to control Italy’s spending, he contends that
300 “we want to create an environment in which investors can
come and be certain that their investments will be evalu-
200 ated in a timely and sensible manner.”
This bureaucracy is particularly problematic for
100 innovators considering running clinical trials in Italy.
Stefano Marini, president of the European CRO fed-
0 eration (EUCROF) and international representative
2001 2003 2005 2007 2009 2011 2013
for Association of Italian CROs (AICRO), explains that
“we currently have around 100 ethics committees but,
Source: Efpia (Key Data 2014), AIFA

COVER STORY
Innovation and responsibility, for patients
World leader in the healthcare sector, the rights of all its stakeholders –
Novartis is strongly engaged in the Novartis is striving to manage its
research and development of medicinal activity in a sustainable way, from a
products and advanced solutions to social, environmental and economic
treat diseases, reduce the burden of perspective. Through its constant
suffering and improve people’s quality focus on innovation and its responsible
of life. With the priority objective to approach to the needs of health, Novartis
satisfy the needs of patients – while is a reliable reference point for millions
meeting the expectations and honoring of people, in Italy and in the world.

COVER STORY
considering that we had around 300 ethics commit- 2018, thus helping to homogenize clinical trial regula-
tees two years ago, there has been some advancement tions across all EU,” which should help to improve Italy’s
in this regard.” According to Marini, the repetition and relative competitiveness.
cumulative fees across these 100 ethics committees More generally, the overall relationship between indus-
mean that “Italy has one of the highest activation costs try and government has improved dramatically over the
in the European region” for starting a new clinical trial, last few years. Fabrizio Chines, executive chairman of
and Thibaud Eckenschwiller, VP and MD for Ipsen Italy Italian ophthalmology specialist SIFI explains that “there
explains that “when we have centers in Italy in which we has been a significant shift in the government’s legisla-
want to enrol in a clinical trial, we are competing with tive stance towards the pharmaceutical industry recently.
other countries,” and compared to Germany for instance Under previous governments, our sector was seen largely
where Ipsen gets “approval or refusal for a trial in three as a target for cost-containment during spending reviews,
months … in Italy it can take up to a year.” Thus, while whereas now we are seeing some efforts to support inno-
progress has been made, greater bureaucratic streamlin- vation.” This shift can be seen in a number of recent poli-
ing will be needed if Italy is to remain an attractive R&D cies, and Chines highlights that “the national government
investment destination; Massimo Scaccabarozzi, presi- has introduced a specific fund for highly innovative drugs,
dent of the pharma industry association Farmindustria, has promised to reduce applicable corporate tax rates,
believes that “the government can play a large role in and has passed legislation to introduce a ‘patent box’ to
allowing R&D to thrive over the next couple of years by reduce the tax rate applied to income sourced from intel-
streamlining the bureaucracy.” With respect to clinical tri- lectual property.”
als, such progress is likely as Marini explains that new “EU
Clinical Trial Regulation will come into effect by October
MADE IN ITALY
Growth’s Regardless of external challenges, the

Italian pharmaceutical industry is
in our nature clearly equipped for success, in terms
of physical capital, expertise, and
culture. “The ‘Made in Italy’ brand
has been identified as one of the
most creative, responsive and pro-
ductive names in the market, which HUBERT PUECH
is embedded in its Italian roots,” D’ALISSAC
The Evolution of Generics
extols Teva Italy MD Hubert Puech managing director,
d’Alissac. Angelini CEO Gianluigi Teva
Frozzi concurs, saying “quality is

definitely inherent in the ’Made in Italy‘ brand and it is
a perception that transcends beyond Italy and Europe.
Our partners recognize the power of the Italian produc-
tion.” Professor Luca Pani, director general of the Italian
Medicines Agency (AIFA), affirms that “there is a “Made
in Italy” element in pharmaceuticals which is just as sig-
IT/ACC/012/02/16
nificant as it is in cars for Ferrari, or in leather for Gucci.

www.accord-healthcare.it We are incredibly good at using numerically controlled
machines, such as those used in pharmaceuticals, and

COVER STORY
Pharmaceutical Innovation: Seeking out the niches
GIOVANNA THILO STADLER has the right to proper pain

LABBATE — treatment,” and as Italians
— regional had traditionally been large-
general manager for
ly resistant to the use of pain
manager, south Europe
Gedeon Richter and the Nordics,
killers even when warranted,
Grünenthal Stadler argues that “this crea-
ted a favorable environment
for us to grow our market
here.” The growth was signifi-
In a pharma market defined 2014 as an innovative product cant, and now “Italy contribu-
by tight budget controls and and our first to be reimbursed tes 20 percent of the group’s
one-to-two year market access in Italy.” This marked a turning total profit in the European
timelines, specialty and niche point for the affiliate “becau- market,” based on revenues
strategies can be quite effec- se it was proof that we were a of more than EUR 100 million.
tive. Giovanna Labbate, coun- completely different company,” In addition, Grünenthal’s Ita-
try manager for Gedeon Rich- according to Labbate; “it is the lian manufacturing operation
ter, explains that the company most innovative product in the Formenti, “is responsible for
“started in 2011 with only one gynecology field – a product producing 11 out of 12 of our
product, the Belara contracep- that addresses the cure for fi- mature products.”
tive,” and is working to make broids.” She concludes that Going forward, Grünenthal
“Gedeon Richter the point of “launching this product cer- has a variety of initiatives to
reference for women’s health tainly helped the identity of expand their position in the
in Italy.” In pursuit of this goal, the company and gave doctors pain management segment.
Labbate has focused her team’s a strong degree of confidence First, given the potential offe-
“knowledge and experience in in our portfolio,” helping to es- red by recent global partner-
this specific sector,” and de- tablish the firm’s leadership in ships signed with MSD and
tails that since the beginning, the women’s health segment. Takeda, Stadler’s goal “for this
“our medical director was a gy- Unrelated to women’s heal- year to make EUR 50 million
necologist,” and when she “ad- th, since 2009 Grünenthal has more in the Italian market.”
ded up the combined number implemented their “strategy Moreover, Stadler explains
of years of experience that our to renew our portfolio in pain that Grünenthal is preparing
staff has in gynecology across management and focus on to launch a unique drug-devi-
all departments – regulatory, sa- becoming a pain specialist,” ce combo “for post-operatic
les, and market access – it came explains the regional mana- pain, which we hope to place
out to more than 220 years!” ger for south Europe and the in hospitals soon,” and will
Her team has also rolled out a Nordics Thilo Stadler. With a allow patients who are “are
portfolio to support “women “solid group of products that typically undertreated after
from adolescence to maternity were the foundation for us to surgery because they are de-
and through to menopause.” grow from, among which was pendent on calling a nurse,”
Breaking into the Italian a pain reliever for cancer pa- to get pain relief “by simply
market with an innovative pro- tients,” Stadler explains that pressing a button.” Moreover,
duct proved more challenging Grünenthal has “managed to he enthuses that this “offers
however. “There were ques- truly establish ourselves in the patients a slightly higher le-
tions about the launch of ESM- pain segment.” In part, their vel of independence,” and he
YA, which proved difficult with efforts were supported by and believes that “it as a truly re-
AIFA,” says Labbate, but after “concurrent with the 2010 im- volutionary product, which will
much hard work “we eventua- plementation of Law 38 in Italy be initially launched in France,
lly launched it in September which states that every Italian then Germany and Italy.”

COVER STORY
there is a very strong SME network a facility in Roverto, which had

in the country. The quality of the “an export budget of USD 113
drugs these companies make is million in 2015,” and, accord-
outstanding, accurate up to 99% ing to Sandoz managing director
and passing every external test.” Manlio Florenzano, is “dedicat-
Signalling the quality and tech- ed to the production of API (Acid
nical sophistication of Italian phar- Clavulanic, Acid Mycophenolate
GEORG FABRIZIO GRECO
SCHROECKENFUCHS maceutical manufacturing is the and Tiamulina).” Moreover,
managing director,
presence of several multinational Florenzano reiterates that “as part Abbvie
country president,
Novartis facilities producing highly inno- of our long-term strategy we con-
vative drugs for the global mar- tinue to upgrade and modernize
ket. Georg Schroeckenfuchs, Novartis country president, our facilities: in 2015-2016 alone, EUR 5 (USD 5.5) mil-
illustrates this fact by saying that “in the cardio-metabolic lion was invested in technological innovation to ensure
therapeutic area we have a standout product in Entresto, the highest standards of quality.”
which has attained great success in treating chronic Other big-pharma and big-biotech players with a sig-
heart failure. Interestingly our worldwide production of nificant manufacturing presence in Italy include GSK
this particular product is carried out here in Italy and with two facilities, Pfizer with four following the integra-
demonstrates our local competitiveness in manufactur- tion with Hospira, a Lilly facility which produces a third
ing vis-à-vis other Novartis manufacturing sites world- of the company’s global insulin supply, and Boehringer
wide.” Novartis’ generics division Sandoz also operates Ingelheim amongst others. Boehringer Ingelheim
SHIONOGI Shionogi
Europe follows the
a new health needs of the patient and the
community that surrounds them.
care company
in Europe This means ensuring that the real-life
challenges patients’ face every day remains
For further
information
the primary purpose behind our R&D. on Shionogi
Europe please visit
Shionogi launched as a new health care company in
www.shionogi.eu.
Europe in 2012. Affiliate offices recently launched
in Germany, Italy and Spain, nearly 140 years
after the organisation was founded (1878)
by Gisaburo Shiono SR. in Doshomachi,
Osaka, Japan, where the global
headquarters are still based.
SHI07_HalfPageAd_V4.indd 1 27/04/2016 15:14

COVER STORY
COMPARED TO THE EU’S BIG 5, ITALY’S SHARE IN MANUFACTURING IS HIGHER

THAN ITS SALES SHARE
ITALY’S ROLE AMONG THE EU BIG 5 CHARACTERISTICS OF PHARMA INDUSTRY IN ITALY:

(% OF TOTAL) INDEX PER EMPLOYEE (OVERALL MANUFACTURING = 100)
Pharmaceutical Investments in manufacturing

manufacturing 26% and R&D 331
100
Pharmaceutical market
Export
(retail+non retail, 19% 285
ex factory values)
100
ITALY IS AN IMPORTANT PHARMACEUTICAL Investments

MANUFACTURER,MANUFACTURING EVEN in environmental 202
protection
OUTSTRIPS ALREADY HIGH SALES
100
Source: Elaboration of Istat data Pharmaceutical industry All sectors
PHARMACEUTICALS IN ITALY RANK TOP IN EUROPEAN MANUFACTURING
WITH REFERENCE TO THE VALUE OF

PHARMACEUTICAL MANUFACTURING, 17.9 278
ITALY RANKS 2ND IN BIG EU COUNTRIES UK 30.4 376
AFTER GERMANY, BUT RANKS 1ST FOR PER
GERMANY
CAPITA MANUFACTURING VALUE
20.1 278
Pharmaceutical Per capita pharmaceu- FRANCE ITALY
manufacturing tical manufacturing
overall value value (€) 28.7 472
(€ billion, 2014 estimates) SPAIN
14.0 301
president Anna Maria Porrini explains that the com- 11.2) million each year in order to keep the facility up to
pany’s manufacturing presence in Italy is through sub- date.” AbbVie’s Italian manufacturing plays a similar role
sidiary “Bidachem SPA, which manufactures APIs and within that organization, as general manager Fabrizio
plays an important role in the provision of our innova- Greco notes, “the Campoverde manufacturing site has
tive drugs. It is considered a strategic production site by been chosen as the global production site for one of the
the Boehringer Ingelheim group and as such we invested three active ingredients in our revolutionary treatment to
EUR 70 (USD 90) million back into the plant in the past eradicate Hepatitis C. The AbbVie interferon-free thera-
five years, and continue to invest around EUR 10 (USD py against hepatitis C is an important research milestone

COVER STORY
The Made in Italy brand may look

in good shape right now, but
this is based on years of solid
investment… going forward,
the country will need to attract
GIORGIO BRUNO
ALDO BRACA ALEXANDER
ZEHNDER
significant investment to the
general manager,
president &
CEO, BSP president &
biopharmaceutical sector to retain
Recipharm
Pharmaceuticals managing
director, Sanofi
its manufacturing prowess
Alexander Zehnder, president and managing

director of Sanofi Italy
that can improve the lives of 160 million patients world- fractionation plant that has been expanded significantly
wide. All these elements position our manufacturing site over the last few years, supplying other Baxalta affiliates
as one of the highest performing and most competitive in worldwide with plasma to process into branded plas-
the AbbVie manufacturing landscape.” Similarly, Baxalta ma-derivatives. In terms of technology, this site is quite
country managing director Fabio Andreola explains advanced even within the context of Baxalta’s innovative
that “our plant in Rieti is a state-of-the-art plasma global manufacturing network.”
Italy is also home to an assortment of international-
ly competitive CDMOs that work closely with many of
these leading multinationals. Leading global CDMOs
including Patheon, Catalent, Famar, and Latina all
have at least one facility in the country, while Sweden
based Recipharm now operates four facilities in Italy.
Recipharm Italy CEO Giorgio Bruno explains that what
his clients look for in a CDMO “partner is quality, effi-
ciency, capacity and reliability. The price is important of
course but it is not the most crucial factor. Flexibility is
key because clients routinely face market fluctuations
and they expect us to be able to act and react accord-
Daiichi Sankyo è un’azienda
ingly.” Citing the global pharmaceutical industry’s shift
farmaceutica giapponese con oltre
100 anni di storia alle spalle, dedicata
from cardiovascular products toward oncology over the
alla Ricerca e Sviluppo di farmaci
innovativi nell’area cardiovascolare
last decade, Aldo Braca’s BSP offers their clients “a strong
e delle infezioni batteriche.
value proposition … because we solve one of the major
Recentemente Daiichi Sankyo sta
focalizzando la sua attenzione verso challenges of the conjugation process,” within their high-
settori terapeutici dove i bisogni di cura
rimangono ancora insoddisfatti, come ly specialized oncology facility. The focus for the CDMO
lo sviluppo di farmaci anticoagulanti,
di trattamenti antitumorali e per il is currently on the construction of two new immunother-
diabete.
apy plants that they aim to have operational by 2019.
Oggi Daiichi Sankyo opera a livello
globale con una presenza in oltre Maintaining the industry’s positioning and reputa-
20 paesi del mondo.
Daiichi Sankyo Italia S.p.A.

tion for quality and innovative manufacturing will cer-
Scopri di più su tainly take some work in the coming years. Sanofi Italy’s
WWW.DAIICHI-SANKYO.IT
President and MD Alexander Zehnder explains that “the

COVER STORY
Diabetes discombobulation
COSTAS PILIOUNIS ERIC BACLET
— — and “Italian production sites pro-
vice president, president and vide 40 percent of the group’s
Novo Nordisk general manager, global insulin requirements.” Ba-
Eli Lilly
clet recounts that over “the last
three years we have launched
Tradjenta and Jardiance, which
are both oral antidiabetics, toge-
“Today there are three to four mi- of course a key market for Novo ther with our partner, Boehringer
llion people in Italy living with dia- Nordisk and Piliounis notes that Ingelheim,” and that Lilly will “be
betes,” says Costas Piliounis, VP “we are the fourth biggest affilia- launching Trulicity in the very near
for Novo Nordisk Italy. Reaching te in Europe and have a healthy future… [and] also launching Aba-
these patients is essential for Italy growth potential left for our bu- saglar, the first biosimilar of Lan-
given the country’s spending sus- siness.” Moreover, “that growth tus.” He reiterates that “these are
tainability concerns, as Piliounis potential is also being translated high-potential, best in class mole-
says “if these people are not trea- into reality, and we are contribu- cules, with extremely positive cli-
ted well, they will develop compli- ting strongly to the overall growth nical trial feedback offering very
cations which will incur far heavier of the group in Europe.” significant improvements over
costs for society, the government However, while Novo Nordisk existing treatments,” and argues
and the individuals suffering from may lead in diabetes today, sig- that they will more than offset
the disease.” Thus, Novo Nordisk nificant competition is on the ho- patent losses from products like
is “always looking for partners- rizon. Eric Baclet, president and Cymbalta. Of these innovative
hips, and for us the latter must be GM of Eli Lilly Italy, warns that products, “Trulicity and Abasa-
a true collaboration grounded on “with the portfolio we have we glar, are being manufactured in
a common goal, which is the fight believe that we will catch up to Italy,” declares Baclet, explaining
against diabetes,” according to [Novo Nordisk] by 2020, and Italy that this feat was “made possible
Piliounis. One area for partners- is a good example of a country in by the more than USD 400 million
hip with the Italian health autho- which we believe that we can be invested in the site over the last
rities is the expansion and conso- very strong in this area.” Already, ten years. This means that both
lidation of patient registries, as he Italy is a major manufacturing hub from a global, and an Italian pers-
adds that he would “like to see an for Lilly, which is “the only insulin pective, we are going to be in a
increased use of registries so that producer in Italy,” according to position to provide a full range of
we can better understand the Baclet, who further explains that treatments to diabetic patients,
effectiveness of the products we “97 percent of our production at from oral treatment to insulin,
are providing on reversing trends Eli Lilly Italy is exported to more and customized to what is best
in the overall population.” Italy is than fifty countries worldwide,” for each patient.”
‘Made in Italy’ brand may look in good shape right now, Sanofi one of Italy’s largest pharmaceutical manufactur-
but this is based on years of solid investment.” Sanofi has ers. Going forward, Italy will need to attract significant
certainly been one of these solid investors in the past, investment to the pharmaceutical, or rather biopharma-
and as such has “quite a large footprint in Italy with an ceutical, sector to remain a premier manufacturing des-
in-country workforce of more than 2700 personnel, of tination, and to continue associating the ‘Made in Italy’
which 1300 are engaged on the commercial side and brand with high quality innovative products. Zehnder
1400 on the industrial side” according to Zehnder, who explains that this is primarily because the global pharma
adds “we contribute some EUR 850 million every year to “market is decisively shifting over to biologics and that
Italy’s GDP and pay EUR 350 million in taxes,” making is an area where Italy seems to be left behind, due also to

COVER STORY

COVER STORY
challenges and limits posed by R&D capacity and invest-

TIME OF ACCESS TO NEW MEDICINES
ments in the country.”
Time elapsing between EMA’s MAs and availability
Certainly, things are moving in this direction. Eli
Lilly has invested USD 400 million over the last few
# of days
years to produce biologics in Italy, and many leading
Italian companies like Chiesi, Dompé, Recordati, and 500
others have shifted their research focus to biotech. 450

450
Furthermore, Italy “is well known for its talented chem-
400
ists and a well reputed chemical industry which has 400
389
been extremely innovative in their ways of production,” 350
according to Teva’s Puech d’Alissac, and this innova- 300
tive spirit will continue to be an asset, even if it is the
250
biochemists and molecular biologists who now must
come to the fore. More importantly, with “such a good 200
heritage of sophisticated production,” in Italy, and the
150 236
reliability Italian manufacturers and personnel have
demonstrated in the past, it is easy to trust Italy as a 100
94
stable manufacturing base. As a final note, Puech d’Al- 50 60
lisac proclaims “we want our patients, the institutions,
0
the government – everyone – to truly resonate in the fact
that ‘Made in Italy’ speaks for value, creativity and inno-
vation and Italy holds all such resources.”
Source: Farmindustria.
STANDING AT THE PRECIPICE as emerging markets such as India and China catch up
in the quality of their own production.”
Despite emerging markets having been a key growth As such, for Italy to remain a relevant production hub
market for many Italian manufacturers in recent years, to the global pharma industry, significant additional
Alberto Chiesi, president of Chiesi reflects that, “further investment will need to be attracted into the country.
development will pose a challenge as these economies Unfortunately for Italy, past success and a tradition of
naturally evolve to drive an economic protectionist pol- pharmaceuticals alone may not be enough given the
icy, usually raising local content requirements.” “The competitive financial incentives offered in many juris-
consequence is either delocalization of manufacturing dictions. As Pfizer’s country leader Massimo Visentin
capabilities or concluding agree- notes, “Global management boards look at countries as
ments with domestic manufac- a whole, and for Italy that means they base their evalu-
turers to license out production,” ation on both the production and commercial side as
he predicts. Meanwhile, Leonardo a single organization.” Thus, for a wide variety of pro-
Vingiani, director of Assobiotec, spective investors, including Pfizer, the potential of the
raises different concerns pertain- local market, and the extent to which innovation and
ing to small molecule products, investment is rewarded, may in fact play a significant
fearing that, “in five to ten years, role in determining the future growth of the Italian
PAOLO our exports of pharmaceutical and pharmaceutical sector.
MARCUCCI medical products, which are cur- Italy’s regulatory environment can sometimes
CEO, Kedrion rently at record levels, will disappear place Italian firms at a competitive disadvantage in

COVER STORY
Lifting the lid on nutraceuticals

MARCO BERNA market with its own finished says Berna, “which is sold as a
— product line,” the company has drug in Europe and as a dietary
business developed multiple innovative supplement in the US. We are
development
nutraceutical APIs and formu- the first company being able to
director, Gnosis
lations. As such, the company produce it by bacterial fermen-
has adopted a rather unique tation.”
business model, where as an Overall, Gnosis’s research
“API manufacturer with strong and commercial model has been
Italian family company Gnosis capabilities in biotech,” Berna quite successful; Berna enthu-
is an API manufacturer with a explains that they “are beco- ses that Quatrefolic, a four-
particular strength in nutraceu- ming increasingly vertically inte- th generation folate, recently
ticals. “Italy has a long tradition grated as we can now develop “won an award in the category
of food and the Mediterranean formulations for our customers, of medical food at Vitafoods in
diet is one of the healthiest in participate in clinical trials, and Geneva.” He clarifies that “in
the world,” says business deve- even provide support in deve- this case we not only developed
lopment director Marco Berna, loping marketing materials and the active ingredient but also
and “we mix tradition, science, commercial strategies.” A key the finished formula by using a
and research for what we call pillar of this strategy is trying proprietary natural coating that
Advanced Nutrition,” highligh- to remain flexible in terms of has been patented.” Moreover,
ting that one of their key pro- production and commercializa- Quatrefolic has been approved
ducts was originally described tion models to fit the regulatory as a ‘new dietary ingredient’ by
by an Italian scientist in 1952, and structural difference of di- the FDA and ‘novel food ingre-
but associated clinical research fferent markets; Berna explains dient’ by the EMA, and more
only conducted more recently. that “one of our key pillars is recently as a ‘food additive’ by
Today, Gnosis’s efforts are focu- also try to find an alternative the Chinese ministry of health.
sed “on two areas; Bioactives, source for natural ingredients, Another product, a yeast deri-
which are directly derived from for nutraceutical and pharma- vative known as Superesse, has
food, and One-Carbon Metabo- ceutical application…. and po- been granted a health claim for
lism, which is how nutrients are sition them in different business osteoarthritis by the Japanese
used in your body.” areas and also in geographically ministry of health following the
While there are no “plans different markets.” “One exam- publication of new clinical trials
for Gnosis itself to enter the ple is the chondroitin sulfate,” in 2015.
international markets. Kedrion’s CEO Paolo Marcucci R&D … It is decidedly appealing to be part of such
explains, “our regulations are often fundamental- an environment.” Still, “It would be so much easier if
ly different to the rest of Europe.” For example, he the bureaucracy were better aligned with the industry
recalls that, “to obtain an import permit to Italy for needs and modus operandi.”
an intermediate from plasma manufactured in an
FDA approved plant, normally takes between 12 and
15 months,” while “companies in other countries that
are achieving exactly the same in a matter of days.” STAYING AHEAD OF THE GAME
However, Marcucci is quick to make clear that “despite
the bureaucracy, restrictions and import delays and There is a palpable degree of inspiration and vision
external competition, there is a lot of knowledge throughout the Italian pharma manufacturing
embedded within Italian suppliers, technicians, and sector that distinguishes the executives leading

COVER STORY
Italian companies and affiliates to a certain extent.

The strong desire to maintain the level of growth and
Traditionally R&D has been
success that has been enjoyed over the last seven years,
and the pressure to remain a vibrant source of growth performed in-house within
to support the national economy, all appear to play a the larger firms [but] the sheer
function in stimulating the famed Italian propensity complexity of innovation today
towards flexibility and creativity. Nonetheless, while
demands a wholly different
the Italian executives leading pharmaceutical com-
panies face the same challenges created by the same
approach
global trends as their colleagues do in other markets,
a surprising majority seem to have clear and decisive Eugenio Aringhieri, CEO of Dompé
ideas about what they are going to do to stay ahead.
Eugenio Aringhieri, CEO of Dompé has demon-
strated decisive leadership more than anyone else in
the industry. As he explains, “it became very clear to to offer the best price and to outcompete your com-
me that the pharmaceutical industry is splitting off petitors by offering an equivalent performance at a
into two very different directions and that the indus- lower cost. Alternatively, you can go down the route
try’s main protagonists will have to choose one path of leadership through your capacity to innovate
or the other. There can be no middle ground or third and be the first mover in bringing latest generation
way. Either your leadership relates to your capability technology to market.” Given this situation, he had
Kedrion Biopharma
plasma-derived
therapies help people
suffering from debilitating
conditions like Hemophilia
and Immune Deficiencies.
We are privileged to
provide
pr this service and do
so with a profound sense
of responsibility.
www.kedrion.com

COVER STORY
to decide which route would be most successful for

Dompé, a traditional Italian family company that in
Aringhieri’s words was “a local, primary-care orien-
tated company connected by commercial alliances.”
Pivotally, Aringhieri concluded that the way forward
for Dompé would be “leadership through innovation,”
and thus today he is “in the midst of transforming
Dompé from a local pharma company to an interna-
tional biotech entity.”
Dompé is far from alone in this shift towards inno-
vation, as Leonardo Vingiani, director of Assobiotec,
says that over “the last six years, we have had an impor-
tant shift in the image of innovation as a driver of our
country’s competitiveness. This is something new for
Italy, and it has a lot of implications, in the attitude
towards research, towards innovation and innovative
products and in the public’s perception of patents.”
Vingiani further explains that, “the magnitude of this
shift can be seen through the number of companies
which have joined our association, which thrives on
innovation. In 2009 we had roughly 70 members,
today we stand at more than 140.”
One such member is Kedrion Biopharma, a globally
competitive leader in plasma derivatives. CEO Paolo
Marcucci explains that the firm’s 15 percent annual
growth rate has been driven by “driven by hyperim-
mune globulins, for which we are leaders in the US
and worldwide. Kedrion is internationalizing its busi-
ness by building a new “a new plant dedicated to the
production of a 10 percent immunoglobulin that will
be launched in 2020” in the US, but Italy will continue
to be central to the production of their most advanced
products; “our production sites in Hungary and in the
US carry out the relatively easy first part of the frac-
tionation process, whereas the complex, high-value
purification step takes place in Italy.”
For many mid-sized Italian firms, successfully inno-
vating in life sciences is becoming increasingly chal-
lenging. Aside from the rising average cost of bringing
an innovative drug to market, Aringhieri highlights
that while “traditionally R&D has been performed
in-house within the larger firms,” today “the sheer
complexity of innovation today demands a wholly
different approach. We’re talking about mastering
the arts of nanotechnology, biotechnology, genomic

COVER STORY
A Virtuous Circle
MASSIMO
DI MARTINO yers and the in-country affiliates no European facility can compete
— of the multinationals alike were outright on price with the Asian
president and subjected to a whole array of basket of countries such as In-
managing
measures from price cuts to the dia and China, but there are still
director,
Abiogen claw-back to restricted market many advantages to be levera-
access. This actually obliged the ged from manufacturing closer
Italian pharma industry to restruc- to home and Italian producers,
ture prior to the global financial with their well-earned reputa-
“Abiogen is proof that Italy can crisis and ironically ended up tion for quality, can exploit this
be competitive in pharmaceuti- serving us well. Italian manufac- reality,” and at the same time
cal manufacturing,” claims CEO turers were compelled to invest can engage in various forms of
Massimo Di Martino. “Back in a lot in upgrading their facilities innovation to differentiate their
2010 we manufactured 18 million and in securing authorizations to products. Through partnerships,
units, but last year I am proud to penetrate new markets as it was Abiogen has been able to enga-
say that we surpassed the 35 mi- necessary to look for revenues ge in the “development of fresh
llion-unit mark. This year, our in- outside of the home country as a formulations, new indications and
tention is to push the boundaries way to stabilize revenues and di- optimized delivery techniques,”
even further and hit 40 million versify risk.” which has had the added value of
units.” This put Italian manufacturers exposing his team “to new ideas
Martino believes that this like Abiogen in a position where and technologies intrinsic to such
competitiveness is “a natural they “can compete well against ventures has enabled us to main-
consequence of the dramatic any Central or East European ou- tain our capacity for innovation
strictures imposed upon the Ita- tfit on both cost and quality for and to raise our game in terms of
lian pharma industry in the early third party manufacturing con- optimizing the ways we conduct
2000s when both indigenous pla- tract.” He admits that “obviously our manufacturing.”
People come
First at Ferring

COVER STORY
and proteomic systems and much by building up and maintaining a formidable network
more. Not even big pharma can of partners.”
aspire to cover all of these bases Partnerships and collaboration have proven equal-
within their own laboratories. It’s ly important for developing successful and competitive
simply neither economically nor incremental innovations. Molteni CEO Federico Seghli
organizationally efficient.” Thus, for Recli, says that for his company, which “ranks among
Italian firms with less access to cap- the largest manufacturers of opioids pharmaceuticals
GIORGIO PISANI ital than big pharma, successfully in Southern Europe,” the “strategic direction is to accel-
general manager innovating requires new strategies. erate internationalization in the niche market of drug
IBSA
The key to these new strategies addiction where there is still a clear room and opportu-
lies in “the rapidly developing nexus nity for a pan-European player.” He explains that from
between networking and innovation within the pharma 2008 Molteni started working “with Archimedes (now a
industry,” according to Aringhieri. He says “it’s far bet- subsidiary of the ProStrakan Group)” to develop a fenta-
ter to develop real mastery in a specific competence and nyl nasal spray; the two companies worked together “on
to blend that with a strong network linking you in to conducting the regulatory trials, and had the product
the best specialists in all the other fields relevant to the approved by the EMA in 2010. At that time, we decid-
technology that you are innovating,” and as such his pri- ed to make this large investment, and it has proven very
ority for Dompé has “been to link up our own in-house successful. We have the exclusive manufacturing rights
capabilities with best-in-class actors all around the world for Europe, and we are in the final stages of extending
this geography to other territories outside Europe.” This
Angelini is a private international group, leader in the health and wellness

area, founded in Italy in the early 20th century, today it has branches in 20
countries and employs about 5,000 people.
Angelini has more than 40-years’ experience in the research and development of
small pharmaceutical molecules, the activities are carried out at the Angelini
Research Center and in collaboration with principal institutions worldwide.
The R&D pipeline is focused on Pain & Inflammation Disorders, Infection Control &
Infectious Diseases and Nervous System Diseases & Disorders.
Angelini developed several drugs. Two of them, benzydamine, an anti-inflammatory

agent for topical use, and trazodone, an antidepressant, are marketed in more than 60
countries. Moreover, Angelini carried out the preclinical and full clinical development of the
fluoroquinolone prulifloxacin.
Angelini R&D is constantly improving its efforts in the area of Infection Control & Infectious
Diseases. Focusing on emerging antibiotic resistance ongoing research projects include the
investigation of original compounds with innovative mechanism of action.
To strengthen its product portfolio in the area, Angelini has licensed dalbavancin, a second
generation semi-synthetic lipoglycopeptide antibiotic.
In the pediatric field, Angelini develops formulations to ensure safe and accurate dosage form of
medicines for children, the product portfolio covering different pediatric therapeutic areas such as pain,
fever and infectious diseases.
A project of high ethical and scientific value is currently ongoing to appraise the clinical efficacy and safety
of paracetamol in comparison to ibuprofen for PDA-Preterm Ductus Arteriosus- treatment in preterm infants.
Angelini S.p.A. HEADQUARTERS

Viale Amelia, 70 - 00181 Rome, Italy
T: +39 06 78053203 / F: +39 06 78332386 M: v.coccoli@angelini.it

COVER STORY
RETAIL CHANNEL 2015: 1.6% GROWTH THANKS TO CONSUMER SECTOR

Source: IMS Health - Multichannel 2015 - Public prices
€25.2 bil.
€10.2 bil. €15 bil.
+
Consumer Rx
market market
+1.6%
vs 2014
+4.1% -0.1%
vs 2014 vs 2014
+
2015 2014
collaboration with Archimedes was only the beginning with Flector and other s products arriving last year, “it
of a larger “strategic partnership with ProStrakan with was crucial to develop a very strong connection with the
whom we expect more projects to come beyond the man- pharmacy channel.” Bouty alone afforded them imme-
ufacturing of PecFent.” diate access to ten thousand pharmacies. Moreover, the
IBSA Italy plays a major role within the organization same transdermal technology is also used to produce a
as Italy is the company’s top market at present and serves product for Novartis, namely Voltadol.
as a global production hub, and has employed a similar
strategy focused on delivery technologies; CEO of the
affiliate, Giogio Pisani, says that IBSA does “not employ
the traditional approach to research” and that instead
BRANCHING OUT INTO CONSUMER
their products are “enhancements of generics” where CARE
innovation tends coalesce around “improvements to
production technology and delivery systems.” For exam- “Angelini is not only a pharmaceutical company.
ple, Pisani explains that star product, Flector, was the Pharmaceutical is one of our activi-
first transdermal use of diclofena which was developed ties, which comprises 50 percent of
by their researchers in Lugan and represents the type of our operations, but we have capa-
“small, but smart innovations that revolutionize patients’ bilities in other sectors as well,”
livelihoods” that the company is becoming increasing states CEO Gianluigi Frozzi. Indeed,
renowned for. In fact, this product’s potential is so signif- Angelini is far from the only phar-
icant that it was also registered in the United States and maceutical company seeking growth
distributed by Pfizer. Devising such innovations entails in areas beyond traditional retail RX
forging new types of collaboration and the continual pharma and has built a broad portfo- GIANLUIGI
acquisition of new skill sets. Pisani explains that, “patch lio ranging from “prescription medi- FROZZI
technology is the main reason we bought Bouty,” and as cations to hospital products to mass CEO, Angelini

COVER STORY
market... with products such as deo- France and Germany, with an income of around EUR 1.6
dorants and feminine hygiene prod- (USD 2.1) billion in 2014,” this affiliate in fact has “the
ucts… [as well as] food supplements, second biggest consumer health business after France.”
both of which we market directly to Enrico Allievi, director of consumer healthcare associa-
consumers.” However, Frozzi makes tion Assosalute, explains that “in Italy, the non-prescrip-
it clear that with “two joint ventures tion medicines market represents 14 percent of overall
with Procter & Gamble to market pharmaceutical sales, amounting to EUR 2.5 (USD 3.25)
GAETANO personal care products, mainly dia- billion, and roughly 16 percent of the national pharma-
COLABUCCI pers,” and “activities in perfumery ceutical market in terms of units.” Moreover, “As a result
general manager and wine,” Angelini is significantly of the [2015] influenza season, the market registered an
Southern Europe,
Beiersdorf more diversified than the average increase both in sales and above all, in volumes,” which
pharmaceutical player. marked the first year of growth for the OTC market in
Although representing only a small part of Angelini’s Italy since 2007.
EUR 1.5 (USD 1.7) billion global business, mass-mar- “I am quite optimistic,” says Allievi, because “Italian
ket healthcare products spanning categories such as health culture and attitudes are changing for the better.
consumer care, cosmeceuticals, nutraceuticals, food Italian people are continually becoming better informed
supplements, and of course traditional OTC pharma- on health.” One factor behind such optimism is that “the
ceuticals represent a significant growth opportunity for Italian market is under the European average, around 15
pharma companies in Italy. Sanofi’s Zehnder notes that percent by volume and a bit less by value, so there is room
while “Italy is Sanofi’s third most strategic market after for improvement as we try to narrow the gap with other

COVER STORY
HEALTHCARE PUBLIC SPENDING Allievi, “a study we conducted in 2010 demonstrates that

CUMULATIVE % CHANGE 2009-2014 if self-medication market in Italy were in line with the oth-
er EU Countries it would lead to savings of almost eight
(*) territorial + hospital, excluding payback
hundred million euros per year which could be used for
reducing public expenditure and for funding more serious
TOTAL PUBLIC pathologies,” and at present Assosalute is “conducting a
EXPENDITURE
(net of interests)
new study to evaluate the overall potential savings con-
sidering not only the cost of drugs but also other indirect
TOTAL PUBLIC costs incurred, such as GPs time and labor productivity
EXPENDITURE
EXCLUDING
losses due to minor ailments.”
HEALTHCARE Gaetano Colabucci, past-president of Assosalute and
HEALTHCARE GM for Beiersdorf Southern Europe, believes “there are
EXPENDITURE two main areas that are critical to fostering this evolution
in mentality: product accessibility and web support.”
PHARMACEUTICAL Beiersdorf has immense traction in the mass-market
EXPENDITURE* channel with their Nivea brand, and Colabucci explains
that it has been a challenge to gain market share in the
PER CAPITA pharmacy channel because “in terms of product acces-
PHARMACEUTICAL
EXPENDITURE* sibility, pharmacists tend to be over concerned with the
exclusivity of their product portfolio.” Contrary to this
stance, he argues that “encouraging product accessibility
-6% -4% -2% 0% 2% 4%
Source: Farmindustria.
European countries.” However, narrowing that gap will

require further driving a cultural change in the attitude
towards self-treatment, which may require multiple strat-
egies; “in Italy there are strong cultural, and economic
differences between the North and the South and this
is reflected in our sales of OTC medication,” according
to Allievi. He says “in the North we are seeing a rise in
self-medication versus prescription drugs and in the
South the opposite is true,” and as such “last year we con-
ducted a study to understand the reasons for differenc-
es in consumption between the North and the South of It begins with a promise
Italy. We are waiting for its international publication and to discover medicines
we are going to use it to reinforce the relationship with
that make life better.
the health institutions on a regional level.”
On the topic of institutional relationships, OTC manu- To find out more about our promise,
visit www.lilly.com/promise.
facturers are well situated to attract institutional support,
as promoting self-care alongside solutions like communi-
ty and homecare may offer a degree of budgetary relief for 2016 CA Approved for External Use PRINTED IN USA
©2016, Eli Lilly and Company. ALL RIGHTS RESERVED.
Italy’s cash-strapped healthcare institutions. According to

COVER STORY
Effervescent innovation in Trento
PAOLO fragile tablets. Innovation and term, we can offer innovations

ANDREATTA collaboration are key pillars to for new therapeutic needs. For
— E-Pharma’s success. “We colla- the long-term future, we are
general director
borate with big pharmaceutical considering developing new
& CEO
E-Pharma companies because they see patented products and produ-
us as a partner not as a com- cing them exclusively.” This fu-
petitor”, says Andreatta. The ture also includes geographical
general director and CEO is expansion. While currently 70
proud of the fact that E-Phar- percent of E-Pharma’s revenue
In a crowded and competitive ma is a reliable manufacturing is generated in Italy, Andrea-
Italian manufacturing environ- company that can meet the tta is very precise about the
ment, E-Pharma Trento has ma- increasingly complex demands company’s direction abroad:
naged to distinguish itself by of big pharma, especially gi- “Our main focus is internatio-
continuously investing into the ven short turnaround cycles. nal expansion and we know
development of new ideas with Next to pharmaceuticals the that the future of our business
the purpose of turning these company is also active in the is abroad”, he declares. In ad-
into patents, particularly in the nutraceuticals segment, which dition to presence in Australia
development and production requires and equal level of and South Africa, he wants to
of niche oral delivery forms, detail and quality and has be- primarily focus on new mar-
such as soluble, effervescent, come progressively important kets, including Vietnam and
chewable and orallydisintegra- over the last few years. Besides Brazil. Pushing the award-win-
ting. This effort has paid off: in developing and manufacturing ning business with new formu-
2013 E-Pharma Trento won the for partners, Andreatta is thin- lations, new technology and
1st prize at CPhI for the best king about a more extensive new products, Andreatta wants
packaging innovation for a business model for the future to build something truly diffe-
special kind of blister for very of the company: “In the mid- rent in these markets.
will not necessarily translate into loss of business for “patient education of OTC products is very complex at
the pharmacists; on the contrary, it could encourage a the moment due to the excess of the Government con-
broader awareness and consumer education.” As such, trols on this subject,” Colabucci argues that “the whole
Colabucci entreats Italian pharmacists to “adopt a new consumer education system would benefit a lot from an
mentality and embrace the benefits that could come from acceleration and simplification of the approval process
offering patients and consumers access to a wider selec- for OTC drugs, and other regulated consumer health
tion of better known and better supported brands.” products.”
“However, one of the most important trends is how Looking at the market, Colabucci identifies a few key
the web is transforming the healthcare system, both in areas of growth within the personal care market. “The
terms of available information and product access,” says anti-aging product line is the most important segment
Colabucci. He argues “the Internet will play a crucial within our portfolio. Indeed, it is part of Italian culture;
role in the next ten years and it will completely reinvent we want to look great and accordingly, our personal
the market,” noting that “we see that more and more budgets for skin care are higher than in other markets.”
information on health related products is disseminated “In addition,” he says, “men’s care products have experi-
through the Internet, especially on issues related to treat- enced an interesting growth trajectory over the last few
ment with OTC products.” Recognizing this reality, this years, and I believe that is only the beginning… men of
is an area that requires attention from regulators because the generation of the 21st century will be much more

COVER STORY
inclined to use personal care products compared to pre- the country in search of funding. Today many of these
vious generations, and we certainly see a change in con- gaps are being closed, and as a whole the Italian life sci-
sumption patterns.” Finally, “natural remedies are anoth- ence community remains a highly competitive destina-
er segment that is gaining importance in this scenario; it tion for R&D investment.
is a big market trend within both the pharmacy channel Italy’s scientific leadership potential is clear to see
and mass-market.” through examining the portfolios and pipelines of
leading Italian innovators. Alberto Chiesi explains that
Chiesi “achieved approval for our new regenerative prod-
uct Holoclar, which will stimulate the regeneration of the
CLOSING THE GAPS cornea, the transparent area forming the front of the eye,
which will help patients to regain vital eyesight. This is
The path from scientific discovery to safe and approved the first stem cell based product approved in Europe!”
product is long and fraught with risk and challenges, and This product was developed by Italian scientists at the
the optimal development path often means a candidate Center for Regenerative Medicine in Modena. Professor
will travel across several geographies along the way. Yet, Luigi Naldini, director of the San Rafaele Telethon
there are many advantages to having access to support Institute for Gene Therapy shares another example of
within a more concentrated environment; without this cutting edge biopharmaceutical science taking place in
access, science parks and technology hubs would not Italy, this in partnership with GSK, and explains that
exist. Italy as a country has fantastic expertise in many “our successful experience with ADA-SCID gene ther-
areas, yet historically many innovators have had to leave apy was the basis for our institute’s alliance with GSK,
Your reference
in the study, development
and production of niche
oral delivery forms
Always researching to create solutions

TO KNOW MORE VISIT
www.e-pharmatrento.com
E-PHARMA TRENTO S.p.A

Via Provina 2. 38123.
Trento - ITALY
T. +39 0461 922818
M. info@epharma.it

COVER STORY
and together we are developing what could become the “SRSI itself is centered on the mission of translational
first ex-vivo gene therapy to be approved anywhere in the medicine. The key feature of the SRSI is the coexistence
world.” of laboratory, hospital and university, which is a rare
These two examples illustrate a point that Leonardo occurrence even globally. Very tangibly, it is uncommon
Vingiani, director of Assobiotec, makes clear when he for a researcher to be able to cross a street and obtain
declares that, “here in Italy, we truly have amazingly tal- patient samples for use in the laboratory, and our inter-
ented scientists.” However, beyond being talented and actions with researchers in the US have impressed on us
productive, Vingiani contends that Italian scientists the rarity of our work situation.” Naldini explains that
“have consistently proven that they are able to do as well the value and synergy of this arrangement stems from
as others, with less resources. It also has to do with the the fact that for basic scientists “it is crucial to speak to a
fact that the cost of a researcher in Italy is 30 percent less clinician early on in the development process. Scientists
than in Germany, France, or the UK, and a full 50 percent need to know if their idea is realistic or not as soon as
less than in the USA.” possible.”
A particular strength of the Italian scientific and Focusing on bringing research into the clinic at an
academic industry is the strong focus on facilitating early stage has been a successful strategy for the SRSI
and optimizing translational research. Many of Italy’s according to Naldini, who explains that one of the
top scientists work within research institutes, the lead- aspects “which greatly contributed to our success was
ing example being the San Raffaele Scientific Institute the establishment of in-house manufacturing capacity.
(SRSI) attached the the San Raffaele Research Hospital. Early on the SRSI spun off what is now MolMed SPA, a
Professor Manuela Battaglia, vice director of the diabe- company which still provides us with the pharmaceutical
tes research institute (DRI) within the SRSI, explains the products needed to conduct our gene therapy trials.” The

COVER STORY
With its new patent agreements, tax credits

and support for hiring PhDs, this is a good
time to invest in the country
Leonardo Vingiani, director of Assobiotec

LUCA GUIDOTTI LUIGI NALDINI
deputy scientific director, San
director, San Raffaele Telethon
Raffaele Scientific Institute for Gene
Institute Therapy
SRSI’s relationship with MolMed is far from the organi- with R&D facilities in Italy over the years, often through
zation’s only relationship with the pharmaceutical indus- M&A activities. While some have scaled back or closed
try; vice-director of the DRI Professor Lorenzo Piemonti such research centers following integration and consol-
explains “very practically speaking, industrial collabora- idations, others have maintained a strong R&D pres-
tion made up 13 percent of our operational budget from ence in the country, in part due to the cost effectiveness.
2008 to 2013.” Boehringer Ingelheim’s president Anna Maria Porinni
Separately from collaborating with Italian academic explains that their “research facility employs 38 research-
researchers, several big pharma companies have ended up ers working hard to develop new chemical entities. The
Pharmaceutical
Services
and Consultancies
TO KNOW MORE PLEASE VISIT

www.op-pharma.it

COVER STORY
center has been very productive in terms of new mole- projects in-country.” Progress is underway, but Italian
cules reaching the pre-development stage, with 14 new entrepreneurs will have to wait for a few more years
chemical entities reaching this milestone in the last 5 before specialized VC firms are more accessible. Capital
years.” Similarly, Novartis once operated an important is still relatively accessible however, because, as Vingiani
vaccines research center in Siena, which was transferred puts it, “with its new patent agreements, tax credits and
to GSK as part of the global division swap between the support for hiring PhDs, this is a good time to invest in
two companies. the country. The atmosphere is very good here, and the
With a big pharma R&D presence or strong life sci- government is very supportive, so we are excited about
ence research institutes that work closely with the indus- the future.”
try and specialize in translate research, the major gap Looking ahead, the future is bright for Italy, although
remaining in the life science environment predomi- not without challenges. Lucky for Italy, Italians are well
nantly affects entrepreneurs. Vingiani explains that “the versed in adapting to change and finding inventive, if not
problems stem from a financial market that is not as straightforward, solutions to tricky situations. Leading
mature as these companies might deserve,” as “in Italy Italian scientists also appear to rapidly be developing a
we are still lacking venture capitalists specialized in bio- more entrepreneurial spirit to complement, and fuel,
tech.” As such, “In the past, Italian scientists have had their academic prowess. For those willing to leave han-
to go to Switzerland, France, and Germany to find the dling the Italian eccentricities to the Italians, it seems to
funding they need,” however this method presents chal- be a pretty profitable place to do business in; the world-
lenges as well as most foreign VC firms say “they need a class wine, top-class gastronomy, and eye-catching fash-
leading local investor to oversee the daily status of the ion are all just a bonus.
80 years in Ophthalmology
SIFI, the leading Italian ophthalmic company, has focused
on eye care since its foundation in 1935.
Open Innovation
Cutting-edge innovation and a clear understanding
of patients and ophthalmologists’ needs have shaped
an extensive range of eye care products, which have also
been developed through collaborative projects.
The ideal partner
Strong driving values, unparalleled legacy in specialty
markets, an agile and evolving business model which
is expanding its presence in Europe, make SIFI the ideal
business development partner for research institutions
and pharmaceutical companies.
SIFI’s latest efforts to improve eye care include ODAK,
an orphan drug development project, Sound Meds, a novel
technology that improves visually impaired individuals’
compliance to pharma therapy, Iluvien, an in-licensed drug
for diabetic macular edema and MINI Well, a first-in-class
PANTONE
3015 C
presbyopia correcting intraocular lens.
More info on www.sifigroup.com

bdevelopment@sifigroup.com

COVER STORY

EMERGING TRENDS
Digitalization
WHITHER
DIGITAL
DISRUPTION?
Preface: Digitalization, a hot topic throughout the
healthcare and life sciences industry, is poised to have
a major effect in Italy through more personalized home
care for patients, allowing the government to cut costs,
and enabling greater public access to innovative med-
ical technologies.
M
any private sector stakeholders see
mobile health and telemedicine
technologies as a great tool to cut
costs through promoting community
and homecare solutions and reducing patient visits to
medical facilities. Stefano Folli, CEO of Philips in Italy,
highlights one study from the UK and Netherlands
where “they have successfully reduced the percentage of
readmissions for patients with certain chronic diseases
by roughly 70 percent,” by enabling “doctors to check
on patients remotely with data collected in the home,
relayed via mobile health technologies to their phy-
sician at the hospital who could then give feedback.”
Yet, according to ResMed’s commercial director Nadia
Cortesi, thus far “telemedicine, a key differentiator in become an actor in national/regional discussion about
tender processes, is not yet used widely in Italy due to the improvement of the whole “value chain” of the
the expense.” treatment of diseases.”
She explains that while “hospitals and patients are ResMed, who produce innovative devices to treat res-
very interested in getting access to telemedicine, and piratory pathologies such as sleep apnea and COPD, is
conceptually people know it will likely reduce costs doing just that. Cortesi underscores that her primary
holistically in the long run,” unfortunately “payers are goal is to “help the public administration to understand
not very open to making the necessary investments that they need to think for the long-term, which they
today.” Indeed, KPMG partner Alberto de Negri con- are not doing at the moment.” First, ResMed has more
curs that “institutions are often reluctant or slow to than validated their value proposition by conducting
take innovation as an opportunity to change the way “long term clinical trials and health economics studies
diseases are treated,” however he also argues that life that demonstrated that patients treated with high per-
science companies can do more to “adjust their ‘glob- formance devices exhibit lower rates of re-hospitaliza-
al’ value propositions to the local situations and to tion and less prevalence of correlated diseases,” and is

EMERGING TRENDS
Digitalization
Thus far telemedicine, a key differentiator in tender

processes, is not yet widely embraced in Italy due
to the expense
NADIA CORTESI
COMMERCIAL DIRECTOR, RESMED
currently “conducting studies in conjunction with our However, the firm is also striving to have an impact
headquarters to demonstrate conclusively and precise- on how sleep apnea is handled in Italy in general.
ly the benefit our telemedicine solutions can bring to Cortesi explains that her main task is “to increase
healthcare providers, hospitals and patients.” awareness, but we cannot do it as ResMed alone;

NEW TRENDS
Digitalization
Most stakeholders have only a general understanding,

not specific knowledge of how implementation of
integrated digital solutions would proceed
DARIO GUIDO
HEAD OF HEALTHCARE AND MEDICAL EQUIPMENT DIVISION, SAMSUNG
it requires a cooperative effort involving all stakehold- sustainability challenges,” as such technologies
ers,” and ResMed is “leading this effort [to coordinate can drive significant gains in operational efficien-
different stakeholders], and has started interacting cy. However, Guido sees a barrier in Italy which “is
with select companies, sharing a plan of awareness that most stakeholders have only a general under-
with support of the scientific societies.” Second, she standing, not specific knowledge of how implemen-
is arguing for stakeholders “to change and simplify tation [of integrated digital solutions] would pro-
the way tests are administered giving access through ceed, and what tangibly it would change.” As such,
for example mobile solutions,” because at present he explains that Samsung has “a collaboration with
“patients seeking a diagnostic test, a polysomnog- the Humanitas Group, the most important private
raphy, they have to wait in some cases even eight health group in Italy, to digitize a hospital that will
months,” which is certainly a contributing factor serve as a model and showpiece going forward.”
behind the fact that “70 to 80 percent of people This showpiece facility will provide a much needed
[with sleep apnea] are not diagnosed.” tangible example of how innovative medical tech-
Some headway is being made, as Cortesi asserts nologies can revolutionize the way medical facilities
that while “the Ministry of Health has not seen and the professionals within them can function.
sleep apnea as a priority, as companies in this seg- There are other approaches to encouraging invest-
ment have been able to increasingly demonstrate ment in medical technologies, namely public-pri-
the cost resulting from not treating sleep-disorders vate partnerships, and innovative outcome-based
effectively, they are starting to consider it a much or risk-sharing agreements as seen with increas-
higher priority.” So far it has been “somewhat easier ing frequency in the pharmaceutical sector. Marco
to convince the authorities to invest in our prod- Campione, president and CEO of GE Healthcare
ucts for chronic patients who depend on our prod- Italy, explains that “the healthcare system in Italy is
ucts in their day-to-day life,” according to Cortesi. asking for help, being squeezed by growing demand,
However, it seems that convincing the authorities to finite resources, poor quality and the worst econo-
go with innovative respiration products is a barrier my for 50 years. That is why we developed the out-
that Resmed must overcome before investing signif- come-based approach to help the national health-
icant resources in persuading institutions to sub- care system with very particular issues, entering
scribe to telemedicine monitoring services. risk- and profit-sharing agreements.” He argues
For hospital IT solutions and digitalization that “companies like GE, that have a sound finan-
in general, Dario Guido, head of Samsung Italy’s cial background can afford to enter these kinds
h e a l t h c a r e a n d m e d i c a l e qu i p m e n t d i v i s i o n , of agreements to help the country’s health system
explains that “Samsung is working to drive digital effectively,” and are an effective mechanism to help
transformations in healthcare everywhere, especial- improve patient access to innovative diagnostics
ly in countries facing significant health spending and therapeutic devices.

ResMed changes lives with award-winning medical devices and cutting-edge

cloud-based software applications that better diagnose, treat and manage sleep
apnea, chronic obstructive pulmonary disease (COPD) and other chronic diseases.
ResMed is a global leader in connected care, with more than 1 million patients
remotely monitored every day. Our 5,000-strong team is committed to creating
the world’s best tech-driven medical device company – improving quality of life,
reducing the impact of chronic disease, and saving healthcare costs in more than
100 countries.
Find more about ResMed at:

ResMed.com Facebook.com/ResMed
Twitter.com/ResMed Linkedin.com/company/ResMed
© 2016 ResMed Ltd. 102242/1 2016-06

MID-CAP STRATEGY
Eugenio Aringhieri, Dompé
INITIATING RADICAL
TRANSFORMATION
Preface: Eugenio Aringhieri discusses Dompé’s shift in strategy towards opthalmology, instilling an innovation
mindset, and broadening the company’s international horizons.
PBR: You were made European CEO in 2015 for are very high and where we can deliver, through an
having steered Dompé through considerable renew- innovative approach to R&D, the right therapeutic
al and restructuring, the company also embarked solutions.
upon a major internationalization strategy and, Next it was important to start assembling an
most importantly, achieved global renown for de- in-house team that was fit-for-purpose and included
veloping breakthrough treatment solutions in oph- all the skill-sets and competencies that were going to
thalmology. All of this is indicative of a major shift be needed to accomplish the endeavor. In the pharma
in business strategy. Please tell us what has changed. world, one of the key differentiators is the quality of
EUGENIO ARINGHIERI (EA): All of these your people: only with the right team you can reach
achievements are intricately connected and derive from your purpose. That is why, in the last year, we have
our courage in facing the future in a different way. selected worldwide profiles with strong professional
Right now, we are in the midst of transforming Dompé skills as well as the aspiration to embrace a challeng-
from a local pharma company to an international bio- ing project focused on the research of therapeutic
tech entity. It became very clear to me that the pharma- responses for “still open” questions.
ceutical industry is splitting off into two very different We had to be frank in acknowledging the gravity
directions and that the industry’s main protagonists and scale of the task at hand: a 360 degree turn from
will have to choose one path or the other. There can be a local, primary-care orientated company connected
no middle ground or third way. Either your leadership by commercial alliances to an international, versatile,
relates to your capability to offer the best price and to R&D driven entity with a wider geographic footprint.
outcompete your competitors by offering an equivalent All of this called for a very different mindset and style
performance at a lower cost. Alternatively, you can go of competency.
down the route of leadership through your capacity to
innovate and be the first mover in bringing latest gener- PBR: How did you go about instilling an innova-
ation technology to market. Our first task was therefore tion mindset?
to decide where to situate Dompé given the emergent EA: The third critical juncture having selected the
trends underway. We had to select which game we want- right game to be playing in and having assembled the
ed to be playing in and ultimately we resolved upon the right team to be able to compete on a level playing field
latter: leadership through innovation. was ramp up our investment in R&D to the point where
The next step was to define how we could compete it now absorbs over 30 percent of our turnover. One way
in that field in a way that would play to the natural that we can accelerate our induction into the world of
strengths of Dompé as a company. I considered it nec- innovation is through our capacity to swiftly grow net-
essary to focalize on specific areas where medical needs works and establish partnerships.

MID-CAP STRATEGY
It’s important to appreciate the rapidly developing much more. Not even big pharma can aspire to cover all
nexus between networking and innovation within the of these bases within their own laboratories. It’s simply
pharma industry. Traditionally R&D has been performed neither economically nor organizationally efficient. It’s
in-house within the larger firms. The sheer complexity of far better to develop real mastery in a specific compe-
innovation today demands a wholly different approach. tence and to blend that with a strong network linking
We’re talking about mastering the arts of nanotechnolo- you in to the best specialists in all the other fields rele-
gy, biotechnology, genomic and proteomic systems and vant to the technology that you are innovating.

MID-CAP STRATEGY
Mastering the arts of nanotechnology, biotechnology, genomic

and proteomic systems and much more. Not even big pharma
can aspire to cover all of these bases within their own laboratories
PBR: Building up your network also meant you facility in L’Aquila. RhNGF is an experimental drug cur-
had to expand your geographic horizons… rently under evaluation in patients affected by rare eye
EA: Absolutely. We had to establish a presence where diseases, like neurotrophic keratitis and retinitis pigmen-
the biotech community is strongest. A full 75 percent of tosa, and goes on to focus on solutions for the treatment
biotech activity takes place in the American, European of more common conditions like dry eye and glaucoma.
and Japanese markets so those are exactly the areas that Pancreatic islet transplantation, meanwhile, pro-
we have flagged up to start building up a physical pres- vides a therapeutic approach for cases of pancreatitis
ence. The process is already well underway. In 2014 we that cannot be controlled by other medical and surgical
opened an affiliate in New York with a view to participat- treatments enabling patients to undergo surgery while
ing in US clinical trials and managing the relationship still being able to control blood glucose levels.
with the FDA. We also have an affiliate up and running Dompé is developing Reparixin, which is being stud-
in Spain and this year will open offices in the other lead ied in its potential to improve the long-term outcome
European markets, namely Germany, the UK and France. of the procedure, based on its peculiar mechanism
The intention is to complete the biotech picture in 2017 of action. The molecule acts on the body’s immune
with a Nordics office responsible for the Benelux and response, which can affect the pancreatic islets’ func-
Scandinavian markets. tion. Reparixin is not yet approved in any country, but
is currently at an advanced clinical development stage
PBR: In terms of choosing a therapeutic area to fo- both in Europe and in the US.
cus on, what was your thought process?
EA: As I have already alluded to, we were intent on PBR As you set about crossing the threshold from
carving out a niche that would play to Dompé’s strengths pharma firm to biotech company and invest 30 per-
given the size of company and the scope of our compe- cent of your turnover in R&D, how are you going
tencies. We needed to identify an area of high value to pa- about stabilizing your income?
tients where needs were going unmet and we could make In the meantime we try to guarantee sustainability
a maximal difference to livelihoods. It therefore made a through improvements to the historical part of the com-
lot of sense to focus on rare diseases as opposed to the pany. We have, for example, decided to invest in the OTC
usual therapeutic areas that start-ups tend to go for such market thanks to an incremental innovation strategy.
as neurology or oncology. The basket of rare diseases is Back in 2008 the mainstay of our business was pri-
actually rather broad – constituting some 7000 variations mary care and most of our partnerships were commer-
in all – so within that group we focused in on two specif- cial in nature. Over time, however, we have been reengi-
ic areas in which we are confident that we can establish neering the nature of our partnerships with firms like
leadership: namely ophthalmology and pancreatic islet Amgen and Biogen to emphasize the value of technol-
transplantation. ogy and know-how transfer. With this knowledge we
Dompé has developed a biotech ophthalmic molecule, have been able to rethink and enhance the delivery tech-
based on the studies that Nobel Prize winner, Rita Levi niques and dosage of some of our most popular prod-
Montalcini conducted on nerve growth factor and have ucts. Today, we have launched in Italy some of the most
been studying a process for industrial-scale production well-known OTC products in areas such as headache,
of recombinant human factor (rhNGF) at our biotech respiratory, pain and inflammation.

MID-CAP STRATEGY
THE
RAREST
ONES
#ICareAboutRare
Watch the video on Dompé YouTube Channel.
Share now.

CENTRALIZING HEALTHCARE POLICY
Collaboration
PUTTING THE PUZZLE

BACK TOGETHER AGAIN
Preface: Italy lags behind its European neighbours in collaboration between both
private and public stakeholders and regional and central government. However,
measures are being taken to move Italy’s highly independent regions closer to-
gether; ultimately impacting the quality of treatment available for the better
both the public and private sectors integrated healthcare and pharma-
LUIGI BOGGIO adapt and evolve to better face the ceutical practices, whereas in Italy
PRESIDENT OF
realities of tomorrow, relationships we have separate teams, reflecting
ASSOBIOMEDICA
AND MD FOR B between stakeholders are changing the sectors’ structure.”
BRAUN significantly. A key feature of the Italian health-
“In Italy there is a never-end- care sector is its highly fragmented
ing conflict between regional and structure, administered under 21
MARIO central governments. The central regional authorities. This fragmen-
MARAZZITI government is progressively trying tation has significant consequences
PRESIDENT OF
THE XII SOCIAL
to decrease the independency of in terms of coordination, standard-
AFFAIRS the regions but resistance is very ization, and efficiency as “in terms
COMMISSION, high,” says Luigi Boggio, president of funding, the central state is pro-
CHAMBER of Assobiomedica and MD for B viding the regions with their budg-
OF DEPUTIES
Braun. Both national and regional ets, but the regions decide to a large
D
institutions are constantly nego- extent how that is allocated, and
oing more with less tiating with the private sector, that introduces an uncertainty to
is a theme that can and until a few years ago dialogue the market,” according to Thibaud
be seen through- between industry and government Eckenschwiller, VP and MD for
out the sector, and was at times nonexistent. This is Ipsen Italy. He continues saying that
indeed, across all of Europe. Cost to say that Italy’s healthcare sec- “as a consequence, it is inevitable,
containment measures have put tor is slightly behind of the rest and to a certain extent this is already
downward pressure on prices for of Europe in terms of cooperation visible today, that you have differ-
pharmaceuticals and medical and collaboration between different ing levels of care available to you
devices, which has in turn “placed parts of the industry. According to depending on where in the country
strong pressure on our industry to Rodrigue Schübelin, partner and you live. Clearly this is contrary to
change,” according to J&J Medical pharma and life science lead for what a national healthcare system
VP Giorgio Milesi, motivating the PwC in Italy, “Italy is behind its should be about.”
adoption of new models, strate- peers. This is reflected within PwC’s Mario Marazziti, member of the
gies, and even research methodolo- organization as well; in countries chamber of deputies and president
gies. Perhaps more significantly, as like France we have established of the XII Social Affairs Commission,

CENTRALIZING HEALTHCARE POLICY
Collaboration
convergence between regions over

The fragmentation inherent to such the coming years. Compared to a few
a regionalized set-up tends to adversely years ago, KPMG partner Alberto de
impact the equality of treatment received Negri claims that “today, the central
government has more control over
MARIO MARAZZITI, MEMBER OF THE CHAMBER
financing and is setting a common
OF DEPUTIES AND PRESIDENT OF THE XII SOCIAL
AFFAIRS COMMISSION methodology for the regions, which
can be applied even at a sub-region-
al level, which ensures hospitals (as
affirms Eckenschwiller’s comments, as 30 percent for regions like Lazio, a starting point) can have a balance
saying that “the fragmentation Molise, Abruzzo, Sardinia, and between cost and revenues and a
inherent to such a regionalized set- Calabria.” As such, he believes that good level of clinical outcomes.”
up tends to adversely impact the “rationalizing public health partly Moreover, potential constitutional
equality of treatment received.” He entails making the system more just. reforms which will be going to ref-
cites data which “demonstrates that It is important that we rediscover the erendum in October 2016 may sig-
there is a 10 percent chance of receiv- values of ‘universality’ and ‘justice’ nificantly impact the balance of pow-
ing inappropriate treatment in the and enshrine them in any reforms er between the central government
Aosta Valley and 20 percent chance that we enact.” and regions, and consequently, the
in Lombardy and South Tyrol, but Wheels are in motion that are likelihood of a recentralization of
then the probability rises as high likely to drive some degree of healthcare administration.
www.pwc.com/pharma
Finding you
solutions
PwC’s Pharmaceuticals and Life Sciences dedicated professionals have the skills
and depth of experience required to help you develop and implement effective
business strategies to meet the challenges you face.
To find out how PwC can help you stay on the leading edge, visit
www.pwc.com/pharma or contact:
Rodrigue Schuebelin +39 06 570252589 rodrigue.schuebelin@it.pwc.com

© 2016 PricewaterhouseCoopers. All rights reserved.
30262 - Pharma advert_landscape.indd 1 24/06/2016 14:43

CONTRACT MANUFACTURING
Going Global
DOPPELING
DOWN ON
GROWTH
Preface: Doppel, one of Italy’s most important CD-
MOs, is poised to make great strides both nationally
and internationally following a significant investment
injection. The company’s CEO describes its potential
to grow both organically and through M&A.
While Doppel is proud to be

a part of Italy’s exemplary
L
eading Italian Contract Development pharmaceutical manufacturing
Manufacturing Organization (CDMO) Doppel, community, we will consider
which counts five of the world’s top ten acquisitions in any country with
big-pharma players amongst its clients, has a
a well-developed and capable
new lease of life after UK based Trilantic Capital Partners
acquired 90 percent of the firm’s equity in October 2015,
manufacturing industry
and has committed to investing additional capital to
help drive the firm’s expansion. CEO Giuseppe Cassisi
enthuses “Trilantic very much considers Doppel to be a volume biotech products; vial fill and finish technology,
strong base in the CDMO industry that can be built upon pre-filled syringes, and lyophilization.” He sees this as an
through organic growth, investment in greenfield facili- area of opportunity as “we see the global pharmaceutical
ties, and the acquisition of other businesses in the CDMO market trending away from large volume small-molecule
industry,” and more importantly the fund “has more than drugs with large patient populations and towards biotech
just financial objectives for their investment in Doppel, drugs with small target populations and thus low-vol-
but rather a clear industrial vision for what Doppel can umes, but high prices.”
achieve with their support.” Cassisi further explains “for In addition to the construction of a greenfield facility,
a private equity fund, they have expressed a willingness to “the second priority will be identifying potential targets
be involved with Doppel for a significant period of time, at for acquisition that fit well with Doppel’s existing busi-
least five to seven years, so we will have the time and sup- ness and vision.” Cassisi explains that “while Doppel is
port to execute substantial investment plans and expan- proud to be a part of Italy’s exemplary pharmaceutical
sion strategies with the goal of growing in terms of size manufacturing community, we will consider acquisi-
and presence across diverse geographic regions.” tions in any country with a well-developed and capable
Plans are already being laid, and Cassisi asserts that manufacturing industry, including the US, Canada, UK,
“our first priority will be to begin construction of a new Germany, France and elsewhere.” However, Cassisi stresses
facility with certain capabilities that we feel will be neces- that “it’s important to recognize that significant organic
sary if we are to become a ‘first tier’ CDMO at the glob- growth possibilities still exist for Doppel; we have avail-
al level.” Doppel already has two production facilities able capacity, can certainly expand the capacity of our
in Italy, but would like to “invest in the injectable field, current facilities if needed, and are always discussing new
specifically in capabilities relevant for small to medium potential projects with clients.”

Think Innovation. Feel Life.®

Think Innovation. Feel Life.®
GRÜNENTHAL is a leader in pain therapy innovation. Founded 70 years ago, the German
pharmaceutical company reached 1.2 bn € revenues in 2015 and sustainably invests on average
Fondato
20 % of 50revenues
anni fa, ilinGruppo
research Farmaceutico
and developmentGrünenthal
– everyhayear.
sede ad Aquisgrana in Germania, realizza
circa un miliardo
Grünenthal di fatturatoon
concentrates l’anno, grazie
selected ad of
fields politica costantemente
pain therapy as well asorientata all’innovazione
state-of-the-art tera-
technologies.
peutica nella terapia del dolore. La strategia di ricerca e sviluppo in Grünenthal
We intensely focus on discovering new ways to treat pain better and more effectively, with fewersi concentra su aree
terapeutiche
side effects.selezionate e su tecnologie all’avanguardia. Ci focalizziamo principalmente sulla ricerca
di We
nuoviat trattamenti
Grünenthal per are ilcommitted
dolore, piùtoeffi
findcaci e con sempre
innovative meno effetti
therapeutic collaterali .
solutions, to provide medical
L’impegno
education as well as to support awareness-raising initiatives aiming at the publicinnovative,
aziendale si concretizza non solo nella ricerca di soluzioni terapeutiche ma
and specialists:
anche in formazione
By delivering e nel sostegno
true benefits ad iniziative
to patients we wantditosensibilizzazione
enable them to rivolte sia ai cittadini,
live a normal, sia agli
nearly pain-free
specialisti per diffondere una nuova cultura del diritto a non soffrire.
life again!
The people working at Grünenthal are our main resource. Our team of highly motivated, talented
Leand
persone sono la
dedicated nostrafollows
people principale
one risorsa:
common in objective:
Grünenthal Toabbiamo
offer thecollaboratori
patients whomotivati, di talento
suffer from pain
e ambiziosi
innovativeche insiemetoformano
therapies improveun team
their in grado
quality di offrire soluzioni concrete per migliorare la qua-
of life.
lità di vita del paziente con dolore.
www.grunenthal.it
www.grunenthal.it

A CASE OF GROWTH
Dr. Massimo Di Martino,
Abiogen Pharma, Italy
LICENSED
TO EXPAND
Preface: The President and MD of Abiogen Pharma discusses his family
company’s recent milestones, the reasons for persisting with local manu-
facturing, and the benefits of international partnerships.
PBR: You created Abiogen established license and distri-

back in 1997, and when Focus bution agreements) and also for
Reports interviewed you back in third parties such as Sandoz, Teva
2009, you were busy bolstering and Mylan. In terms of the current
the company’s R&D capabili- split in volumes and workload 80
ties and forging new partner- percent is produced for us and our
ships. What would you say have partners and 20 percent for the
been the main milestones and third parties.
achievements over the interven- We have been very attentive
ing 7 years? to upgrading and updating our
Since 2009, Abiogen has under- facilities when the possibility has
gone transformative change to arisen. Initially we had a single PBR: Tell us more about taking
both the business model and our production line for liquid oral the “made in Italy brand” abroad.
competitive positioning. We have formulations but, over time, have We understand your target is to
registered an impressive growth expanded that to three. Lately we increase the contribution of ex-
trajectory both in capturing mar- have been investing in incorporat- ports to overall company revenue
ket share and in pure sales pow- ing sterile areas. We already have from 3.5% today to 13.5% by 2020.
er. The manufacturing side of the one fully functional zone with- There are many unmet medical
business has developed especially in our production site, but are needs out in other geographies that
well and I am proud to say that keen to create a completely new even some of our popular, older
Abiogen has evolved into one of the ‘island’ within our production assets could well respond to. Some
top performance pharma companies plant so as to enable speedy FDA would constitute new chemical enti-
in the country. Today we rank inside approval of our products when ties in other markets outside of Italy
the top twenty players for volume endeavoring to penetrate the US so it makes sense to leverage this
and within the top 30 for value. market. Our manufacturing facil- potential and make full use of our
ities are not only accredited with product portfolio. We are intending
PBR: We understand that European GMP certification, but to really ramp up or export volumes
your production capabilities also with equivalent awards cov- in the coming months and years.
have now expanded to include ering Arabian Countries, Middle Recently we have been busy prepar-
third party manufacturing… Eastern and North African coun- ing the groundwork and acquiring
Absolutely. We are now manu- tries, and even the South Korean the requisite certification for the
facturing for Abiogen’s own port- market. Currently we are awaiting overseas regulatory authorities in
folio, for our partners both inside an inspection from the Russian the markets that we wish to target.
Italy and abroad (where we have federation as well. We were able to secure authorization

A CASE OF GROWTH
Dr. Massimo Di Martino,
Abiogen Pharma, Italy
grow together, as opposed to opt-

ing for ventures where our power of
negotiation is vastly reduced and the
relationship rather asymmetrical.
PBR: Abiogen has made R&D

the core of its value-offering for
over 50 years. How do you go
about securing market access for
your products under the prevail-
ing economic climate in Italy?
Right now, we’re at a certain
juncture in the history of Italian
healthcare policy where governance
There are many unmet medical needs out of public health is undergoing pro-
in other geographies that even some of our found changes, and at the same
popular, older assets could well respond to. time Italians have to grapple with
Some would constitute new chemical the challenges of working with the
entities in other markets outside of Italy individual regions. This prolongs
the time it takes to reach market,
and has resulted in some significant
shifts in the market structure.
from the notoriously stringent to renew our portfolio and upgrade Over the past 10 years, for exam-
South Korean regulator in only 9 our manufacturing processes and ple, multinational innovators have
months, which is quite a feat and know-how. seen their profits being eroded by
testament to our high baseline on For licensing-in, the value of our genericists in areas like chronic
quality. brand reputation comes to the fore. impairments as their patents expire
Our strong track record and endur- while waiting for secure reimburse-
PBR: How important is part- ing capacity for innovation render ment authorization. As a reaction,
nership-building as an enabler to us a partner of choice and result in most of the big pharma companies
your expansion into new markets the repeated renewal of our license have been reducing the investments
abroad? agreements. For the licensing-out, on those sorts of product lines, i.e.
Abiogen has always exercised a we are making an effort to select closing down some dedicated sales
very open door towards partner- young, dynamic and high perfor- forces, and instead focusing their
ship building. Although we believe mance SMEs that will consider our energies on a more limited num-
that our assets are solid, we are not product important and collaborate ber of high-price, high-impact
yet convinced that our assets are from a level of equality rather than innovations. At Abiogen, we have
innovative and exclusive enough opting for supersize-entities where to find our own space and expand
to start opening affiliates abroad. the relationship will be much more our presence by adjusting to the
Therefore, licensing-out is the most impersonal and the priority afford- trends. When the average price
obvious mechanism for enabling ing to our product weakened due of products in our portfolio lies
us to reach out into new markets to the sheer number of production below 4 euros, we really need to be
and to expand the footprint of our lines that will be in operation. In chasing maximization of volume
products. Licensing-in, on the other short, our strategy is to seek out while never sacrificing our propen-
hand, brings us great opportunities genuine partners with whom we can sity for innovation.

INDEX
Including advertisers
Advertisers
COMPANY NAME PAGE #

Abbvie 4, 40, 42, IBSA 26, 50, 51
Abiogen 29, 49, 72, 73 IMS Health 6, 23, 25, 27, 32, 33, 51,
Accord Healthcare 30, 38 Ipsen 8, 9, 38, 56, 68
AICRO 36 ISS 24, 30, 31, 32, 36,
AIFA 15, 22, 25, 27, 32, 33, 36, 38, J&J Medical 14, 16, 17, 18, 19, 23, 35, 36, 68
Amgen 26, 27, 66, Kedrion 45, 47, 48,
Angelini 8, 9, 38, 50, 51, 52 KPMG 14, 15, 60, 69,
Assobiomedica 15, 68 LEO Pharma 27,
Assobiotec 26, 30, 45, 48, 56, Lilly 40, 43, 45, 53
Assogenerici 30 Menarini 8, 9, 23
Assosalute 52, 53, Merck 23,
Astellas 11, 36 Ministry of Health 4, 15, 16, 19, 22, 24, 31, 62,
B Braun 15, 68 Molteni 30, 32, 50
Baxalta 26, 28, 42 MSD 31, 39,
Bayer 23 Novartis 23, 31, 37, 40, 51, 58
Beiersdorf 4, 53 Novo Nordisk 22, 43
Boehringer Ingelheim 28, 40, 43, 57, OP Pharma 23, 30, 57
Bomi Group 8, 9, 36, Orion Pharma 33,
BSP 22, 42 Pfizer 13, 22, 23, 25, 26, 30, 31, 32, 40, 45, 51
Celgene 28, Philips 4, 14, 23, 24, 60,
Chiesi 9, 10, 11, 12, 45, 55, PwC 8, 9, 68, 69
Daiichi Sankyo 34, 42 Recipharm 42
Dompé 27, 45, 47, 48, 50, 64, 65, 66, 67 ResMed 60, 61, 62, 63
Doppel 8, 9, 48, 70 Roche 22, 23,
E-Pharma Trento 4, 54, 55 Samsung 62,
EUCROF 36 San Raffaele Scientific Institute (SRSI) 56, 57
Euro Generici 30, 59 San Raffaele Telethon Institute
Farmindustria 7, 8, 22, 24, 25, 38, 45, 53, for Gene Therapy 55
Ferring 25, 27, 32, 49 Sandoz 25, 30, 40
GE Healthcare 62 Sanofi 20, 23, 35, 42, 43, 52
Gedeon Richter 35, 39 Santen 34
Gilead 23 Shionogi 33, 40
Gnosis 4, 31, 46 Shire 24, 28
Grünenthal 39, 71 SIFI 8, 36, 38, 58
GSK 23, 40, Teva 38, 44, 45

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Photo page 3: Severini, Gino. (1915) Train de la Croix Rouge traversant un village. Solomon R. Guggenheim Museum,
New York Solomon R. Guggenheim Founding Collection. © 2016 Artists Rights Society (ARS), New York / ADAGP, Paris.
Photo © page 8-9: Flickr: Davide D’Amico. Galleria Vittorio Emanuele II, ceiling.
Photo © page 14-15: Balla, Giacomo. (1913) Paesaggio, Italy.
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SMART GROWTH PUTTING THE PUZZLE SEEKING OUT MID-CAP STRATEGIES:

STRATEGIES: AN ITALIAN BACK TOGETHER THE NICHES THE DOMPÉ

Beatrice Lorenzin, minister of health, Italy

Walter Ricciardi, president, national institute of health, Italy

Luca Pani, director general, AIFA, Italy

Massimo Scaccabarozzi, president, Farmindustria, Italy

Leonardo Vingiani, director, AssoBiotec, Italy

Gian Mario Baccalini, president, Aschimfarma

Enrique Hausermann, president, Assogenerici

Enrico Allievi, director, Assosalute, Italy

As well as all the companies we have met for their support,

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JOIN THE CONVERSATION

AMPLIFIED CONTENT IN BRIEF

JAAP HEUKERS – Managing @pharmaboardroom

PAOLO ANDREATTA – CEO, Read the interview

Read the interview

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ITALY IN THE INTERNATIONAL RANKING OF THE PHARMACEUTICAL INDUSTRY

ITALY (90% GRADUATES)

2005 2014 2018

DATA ON R&D INVESTMENTS IN ITALY

6 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

PHARMACEUTICAL AND UPSTREAM SECTORS BY REGIONS

1 Lombardy 2 Veneto 8 Emilia Romagna

Source: Farmindustria, Osservatorio Pharmintech, Istat

MEDICINES EXPORT GROWTH 2010-2014

8.1 8.0 7.9 6.9 5.6 1.6

0.5 0.3 -0.05 -0.5 -2.7

www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 7

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PBR: Mr. Chiesi, 2014 was a definitive year – 8.4

10 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

We strive towards globalization while maintaining our medium size…

www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 11

What’s holding back digital disruption is the question of ethical

12 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 13

14 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

reliable and actionable information to drive smart health-

www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 15

Imagine a world where no child suffers

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18 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

PBR: How is Johnson & Johnson Medical

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SANOFI, A GLOBAL LIFE SCIENCES COMPANY

Sanofi is a global life sciences company committed to improving

20 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 21

Right now we are regarded as the second

22 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

INNOVATION IS DEFINING LEADERSHIP OF THE SECTOR

Hospital Direct-to-Patient Distribution Retail Value Growth — CAGR

GILEAD 100% 135%

www.pharmaboardroom.com Healthcare & Life Sciences Review: Italy 23

the first time since WWII … In fact, this may be one

Cody and Kolten, living with Gaucher disease IT/C-APROM/CORP/16/0005 shire.com

24 Healthcare & Life Sciences Review: Italy www.pharmaboardroom.com

Generics: Playing Catch-up