CASE STUDY-

THE MEDICINES COMPANY

PRESENTED BY-
ASHMITA HAZRA (23MB4010)
MEGHA MUKHERJEE (23MB4021)
TEJASH RAI (23MB4031)
 The pharmaceutical industry discovers, Top 20 Drug Companies by Revenue (2022)
develops, produces, and markets 120,000
pharmaceutical drugs for the use
as medications to be administered to patients, 100,000
with the aim to cure and prevent diseases, or
alleviate symptoms. 80,000

 Pharmaceutical companies may deal 60,000

in generic or brand medications and medical
devices. 40,000

 They are subject to a variety of laws and 20,000

regulations that govern the patenting, testing,
safety, efficacy using drug testing and marketing 0
r I
E E S BB A SK DA NY CES YER EN EIM ISK NA aA CH
of drugs. fize SON CH CO BVI RTI I O F EC G E A G D R G E
U N
P
H N RO K & AB VA
SQ SA ZEN T AK MP CIEN BA AM ELH OR DE K K N T
JO C NO ERS N O RC IO
& ER T RA CO D S ING O M E B
M Y S D A R V M
 The global pharmaceuticals market produced N M A A N L E E O
NS
O
AL L Y GI IN
G N
treatments worth $1,228.45 billion in 2020 and H IST I L R
JO BR L IL EH
showed a compound annual growth rate (CAGR) E BO
of 1.8%. COMPANY
 Subsidiaries: Incline Therapeutics, Inc.,
 CEO: Mark Timney (11 Dec 2018 – till)
 Parent organization: Novartis
 Headquarters: Parsippany-Troy Hills, New Jersey,
United States
 Founded: 1996
 Founder: Clive Meanwell
 Executive vice president: Peter Wijngaard
 The co. acquired, developed , and commercialised
pharmaceutical products in late stages of development
 By early 2001, the co. had acquired the rights to
ANGIOMAX that BIOGEN had abandoned after $150 M
and seven years of development.
 Drug Development
Drugs Market Potential
•Life-saving drugs are necessary.
•The US trends anticipated an increase in the aging population from 35 million in 2000 to 55 million by 2020.
•Growth potential in the world wide market was 10% annually and the benchmark revenues in 2000 was posted at $200 billion.

Stages of Drug Development

Preclinical/ Phase I Phase II Phase III FDA

4000 20 14 9 2 1
Candidate Animal Clinical Clinical Clinical Submission FDA
Drug Testing Trails Trails Trails /Review Approval
(3-4 years) (1 years) (1-2 years) (2-4 years) (1 years)
 Bivalirudin, sold under the brand names Angiomax and Angiox and manufactured by
The Medicines Company, is a specific and reversible direct thrombin inhibitor (DTI).
 Chemically, it is a synthetic congener of the naturally occurring drug hirudin, found in
the saliva of the medicinal leech Hirudo medicinalis.
 Bivalirudin lacks many of the limitations seen with indirect thrombin inhibitors, such
as heparin.

Based on the results of clinical trials:

 The drug provides promise in the curative aspect of heart

problems.
 500,000 in 14 million afflicted people in 1990.
Features of Angiomax.
 Predictability of the treated patient's response.
 Management of bleeding.
 Fast action over heparin.
Status of Angiomax Clinical Trials
Pre- Phase 1 Phase 2 Phase 3 New Drug Product
Clinical Application Launch
Angioplasty

Heart Attack

Heparin Induced
Thromb Ocytopenia
Unstable Angina

Coronary Artery
Bypass Surgery
 Heparin
 Heparin, also known as unfractionated heparin (UFH), is a medication and naturally
occurring glycosaminoglycan.
 Since heparins depend on the activity of antithrombin, they are considered anticoagulants.
 Specifically it is also used in the treatment of heart attacks and unstable angina.
 It is given intravenously or by injection under the skin.
 Other uses for its anticoagulant properties include inside blood specimen test tubes and kidney
dialysis machines.

Heparin Use Across Treatments

Treatment No. of Patients Per Year Receiving Drug
Unstable Angina (i.e., elevated chest pains) 1,300,000
Heart Attacks 1,000,000
Balloon Angioplasty 700,000
Coronary Artery Bypass Surgery 400,000
Other 100,000
Despite its almost universal use, Heparin was not without it shortcomings, however, as Meanwell was quick
to point out.
These included:
 Unpredictability.
 High risk of bleeding.
 Adverse reaction.

Overall Sati sfacti on with Heparin among Interventi onal Cardiol -

ogists

6% 3%4% 5% Response to the Question:

13% Using a 10-point satisfaction rating scale, please
24% rate your overall satisfaction with heparin as an
anticoagulant when administered during a
16% balloon angioplasty procedure.
(1 = Not at all Satisfied; 10 = Extremely Satisfied)
Number indicate the percentage of doctors
29%
reporting the rating shown in parentheses.

1 2 3 4 5 6 7 8 9 10
 Angiomax VS Heparin

Heparin and Angiomax are both anticoagulant medications used to prevent blood clots, but they have some key differences:

 Mechanism of Action:
Heparin: It works by enhancing the activity of antithrombin III, a natural anticoagulant in the body, which inhibits the formation of blood
clots.
Angiomax (Bivalirudin): Angiomax directly inhibits thrombin, an enzyme involved in blood clot formation.

 Administration:
Heparin: Typically administered intravenously (IV) or subcutaneously (under the skin).
Angiomax: Also administered intravenously.

 Monitoring:
Heparin: Requires regular monitoring of the activated partial thromboplastin time (aPTT) or anti-Xa levels to ensure the appropriate
dosage.
Angiomax: Monitoring is generally not required because its action is more predictable.

 Reversal Agent:
Heparin: Can be partially reversed using protamine sulphate.
Angiomax: Reversal options are more limited and may involve waiting for the drug to clear from the body.
 Angiomax VS Heparin

Phase III Results for “High-Risk” Patients Phase III Results for “Very High-Risk”
Undergoing an Angioplasty Patients

Outcomes within 7 days of Heparin Angiomax Outcomes within 7 days of Heparin Angiomax
Treatment (2,151) (2,161) Treatment (2,151) (2,161)
(number of patients in condition) (number of patients in condition)

Death 0.2% 0.2% Death 0.5% 0.0%

Heart Attack 4.2% 3.3% Heart Attack 5.6% 3.0%
Need for a Repeat Angioplasty 2.8% 2.5% Need for a Repeat Angioplasty 3.5% 2.4%
Experienced Major Bleeding 9.3% 3.5% Experienced Major Bleeding 11.8% 2.4%
 S W O
 Market Growth.
T
 Regulatory
 Innovative pipeline.  Limited product
 Unique business portfolio.  Expending changes.
model, acquires Indication.  Patent Expirations.
 Dependence on
drugs in late stage  Aging population.  Healthcare reforms.
clinical trials.
development.  United States is the
 Experienced  Investors have little  Emerging
most profitable drug
Research Team. confidence. Competitors.
market.
 Lower product R&D  Product launch takes  Government and
costs. an average of 10 managed care
 Partnership & collab. years. organization
 High return on  Difficult market entry pressuring drug
investment ratio if because of high companies to lower
product is price. drug prices.
successful.  Growth in generic
 Financial stability. drug market.
 1. Pricing 4. Realities of the stock market
A)Setting a reasonable price A) Re-examining the core business strategy
B)Bringing down the cost of using Angiomax B) Finding out the main reason of failure in the stock
C)Effective Marketing market

2. Need to develop product portfolio

A) Through knowledge about the product
B) Improving the product according to the changing
needs

3. Effective strategy to handle the problems

related to the drug development industry
A) Animal trails
B) Phase 1 clinical trails
C) phase 2 clinical trails
D) phase 3 clinical trails
E) FDA submission
 The company should have more focus on pushing the sales of
Angiomax and to make a strong distribution network and try to have
deeper access to the hospital staff and administration.

 They should also focus to market themselves as a superior alternative

of heparin and modern solution and spread awareness is the medical
industry about the presence of Angiomax. As it would help in the growth
of the company.

 Their business strategy of acquiring/rescuing the abandoned drug was

quite odd but good as it saved money and time of the company in early
stages of drug development and projected growth of the industry was
nearly 10% per year their drugs will make a potential difference in the
lives of the people
THANK
YOU