November 08, 2014

Pharma Sector Update

(Sector Analysts: Kanika Singh, Neha Kumar and Ravi Karanam)
USFDA revokes Ranbaxy's 180-day exclusivity on sale of two generic drugs in US, grants
approval to Dr. Reddy for one of them
The USFDA has reverted its tentative approvals granting Ranbaxy six-months sales exclusivity of the
generic versions of Roche's anti-viral drug Valcyte and AstraZeneca's heartburn pill Nexium. Ranbaxy
had first-to-file status on both these drugs and it was expected to earn USD 60 million and USD 180
million from the generic versions of Valcyte and Nexium respectively in the exclusive sale period. The
USFDA said that its original decision of granting tentative approvals were erroneous because of the
compliance status of the facilities mentioned in the ANDAs (Abbreviated New Drug Application) filed by
Ranbaxy, as a result of which in FDA's view, Ranbaxy had forfeited its eligibility for 180-day exclusivity for
its ANDA for Valcyte. The news could hit the shares of Ranbaxy and Sun Pharma, already under CCI's
scanner for the $4 billion M&A deal, the decision for which is expected this month. Earlier in the
week,Ranbaxy had received approval from the USFDA to manufacture and market Fenofibrate capsules,
used for lowering high cholesterol and triglyceride levels in the blood.
The revocation of Ranbaxy's 180-day exclusivity on sale has turned out to be a positive news for Dr.
Reddy's Laboratories which has been granted the final approval by USFDA to make cheaper versions of
Valcyte. The company is expected to launch the drug shortly in the US market.

ROC questions Plethico Pharmaceuticals over complaints from investors on the fixed
deposit schemes
The Registrar of Companies (ROC),Gwalior is inspecting the books of accounts of the Indore-based
Plethico Pharmaceuticals, following hundreds of complaints received by the investor grievance cell of the
corporate affairs ministry for almost a year. The investors claimed that the company had not returned their
money despite the maturity of the fixed deposit scheme. The number of investors and the amount of
money raised will be clear after the initial probe is complete. A statement from the company said the
company is currently facing temporary liquidity issues which are in the process of being corrected and
normalized shortly and that the fixed deposit holders have been explained the position and the course of
action by the company.

IPCA Labs reported 15% intra-day loss following reports of stock downgrade by Credit
Suisse
On Wednesday, shares of IPCA Labs closed with a sharp loss of 10.5% on the BSE dipping its market
value by Rs 994.88 crores to Rs.8432.12 crores. The shares took a hit after reports of downgrading of
the stock from 'neutral' to 'under-perform' citing negative observations from the USFDA in its Form-483 for
its Indore SEZ. Out of the six observations made in the Form-483, two are being considered critical

pertaining to the practice of conducting trial/unofficial samples and overwriting/deleting raw data files, as
similar observations resulted in adverse FDA action at Sun's Karkhadi unit and Wockhardt's Waluj unit.

Glenmark Generics and Lupin get USFDA approval for ulcer and arthritis treatment drug
respectively
Glenmark received the US health regulator's final Abbreviated New Drug Approval to market Omeprazole
Delayed Release Capsules, their generic version of AstraZeneca's Prilosec used for treatment of ulcer. In
similar news, Lupin said it had received final approval from the USFDA to market Celecoxib capsules,
their generic version of GD Searle LLC's Celebrex capsules, used for treatment of arthritis in the US.

Government panel recommends waiving off clinical trials for two cancer drugs
The Drug Technical Advisory Committee, headed by Mr. Jagdish Prasad, Director General of Health
Services has recommended waiving off of clinical trials of two medicines Aflibercept and Trastuzumab
emtansine used in the treatment of cancer considering that the drugs have been tested in various other
countries and have been found to be effective. The law allows waiver of clinical trial in Indian population,
only for drugs approved outside India, if there is national emergency, extreme urgency, epidemic, orphan
drug or a disease for which there is no therapy. Many health experts feel the proposed clinical trial waiver
to the two cancer drugs is in violation of rules and can have serious implications for patients since it does
not even qualify for exemption as there are other alternative therapies available. According to Mr. Amit
Sengupta, co-convenor of Jan Swasthya Abhiyan, a public health advocacy movement, generally clinical
trials in India do not come up with any new data. On the contrary, trials costs a lot of money which the
consumers have to pay later and also cause a delay in the entry of crucial medicines.