November 15, 2014

Pharma Sector Update

(Sector Analysts: Kanika Singh, Neha Kumar and Ravi Karanam)
USFDA rebukes Cadila Pharmaceuticals over significant deviations from standard
manufacturing practices
USFDA has issued warning to Indian pharma company Cadila Pharmaceutical for lapses found in the
quality and manufacturing standards in its Ankleshwar plant in Gujarat in its inspection in March. If the
company fails to take corrective measures, the agency can ban exports to US from the plant. US happens
to be the biggest market for India's $15 billion generic manufacturing sector but a number of warnings and
sanctions over the last year have damaged India's reputation as a supplier of safe and affordable drugs.

Sales in US takes a hit due to slowdown in the new generic drugs approval process
Dr. Reddy's Laboratories and Glenmark Pharmaceuticals reported a drop in their second quarter US
sales blaming the slowdown in the approval process. Sun Pharma managed a 15 percent rise in its
quarterly profit, reporting a profit of Rs 15.72 billion for the quarter, nearly meeting the estimate of Rs
15.88 billion, driven by strong growth in sales in the domestic market. On the other hand, Cipla reported a
16 percent drop in its quarterly profit, hit by the sluggish sales in US market due to slowdown in the new
generic drugs approval process.

Venus Remedies gets approval to market its generic drug meropenem in Switzerland
Generic drug maker Venus Remedies received approval from the Switzerland drug authority, Swissmedic
to market its generic injectable antibiotic meropenem used in the treatment of severe bacterial functions
like pneumonia and broncho-pulmonary infections among others. The company plans to launch the
product early next year through its partner Swiss Pharma GmbH Zurich and expects to capture 10
percent share in the meropenem market in Switzerland. The company has got marketing approval from
more than 40 countries such as UK, France, Germany, Saudi Arabia, Australia and Italy among others.

Singapore investment company, Tesmasek acquires 10.16% equity stake in India's Intas
Pharmaceuticals
Intas Pharmaceuticals, is a leading, vertically integrated global pharmaceutical company from India with
end-to-end capabilities of formulation development, manufacturing and marketing along with backward
integration of APIs. Intas has emerged as one of the fastest growing pharmaceutical companies of the
world backed by decades of progressive strategies, productive R&D, biotechnological expertise and
investment in ten advanced manufacturing facilities across the globe. Temasek has acquired the 10.16%
equity stake by way of secondary purchase of shares from private equity investor ChrysCapital.

November 15, 2014

Three-year old joint venture between Sun Pharma and Merck & Co called off
Sun Pharma and Merck & Co have decided to call off their joint venture which had aimed at developing
innovative and differentiated drugs for emerging markets in Asia Pacific, Latin America, Eastern Europe,
Middle East and Africa. According to the agreement, Sun Pharma was supposed to provide its product
development skills and manufacturing facilities and Merck, its regulatory competence and market
presence. The reason for the decision is not known yet.

NPPA set to include 100 new drugs under price control

Currently, the government includes 348 medicine formulations that are listed in the National List of
Essential Medicines (NLEM). However, this list includes only specific dosages, strengths and
combinations of medicine formulations. NPPA (National Pharmaceutical Pricing Authority) believes this
loophole does not ensure price regulation of all life saving and essential medicines of mass consumption.
The move to include the new drugs is aimed at expanding the span of price control to include medicine
dosages, strengths and combinations which are commonly used and have high market share by sales.
Earlier in May this year, the NPPA had slashed down prices of 108 drugs which were outside the NLEM
under the public interest clause. However, it had to withdraw the guidelines after the companies
approached the court and the law ministry was of the opinion that the using of the clause was not
required.

Aurobindo Pharma set to buy Natrol Inc for $ 132.5 million

Aurobindo Pharma has emerged as the highest bidder to buy the US-based nutritional supplement maker
Natrol Inc owned by the Indian pharmaceutical firm Plethico Pharmaceuticals for $ 132.5 million. Natrol
Inc had filed a bankruptcy application in June this year. Aurobindo believes Natrol is an excellent strategic
fit for the company and provides the right platform for creating a fully integrated OTC platform in US and
other international markets.

References
http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharmaemerges-top-bidder-to-buy-natrol-inc-for-132-5-million/articleshow/45119155.cms
http://www.etintelligence.com/etig/researchchannels/sectors/pharmaNews.jsp
http://www.pharmabiz.com/