Glenmark Generics receives approval from the USFDA for Calcipotriene Ointment

Date: 26 March 2010

Press Release                                                                                          For Immediate Release     

Glenmark Generics receives approval from the USFDA for Calcipotriene Ointment 

March 26, 2010 : Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have received final approval from the United States Food and Drug Administration (FDA) for Calcipotriene ointment 0.005%. 

Calcipotriene ointment was marketed by Leo Pharmaceuticals as Dovonex® ointment from its approval in December 1993 through April 2007, when the product was discontinued due to commercial viability. The brand garnered peak sales of approximately USD 93 million in the calendar year 2006, according to IMS Health. Leo Pharmaceuticals still markets and distributes a line of Dovonex® products including a cream and a topical solution. Glenmark’s approved version of calcipotriene ointment 0.005% is indicated for the treatment of plaque psoriasis in adults. 

About Glenmark Generics limited.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.  GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.  

About Glenmark Pharmaceuticals Ltd.  

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.], Metabolic Disorders [diabetes, obesity, etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres. 

Disclaimer“Glenmark Generics Limited (“Company”) is proposing, subject to market conditions and other considerations, a public issue of its equity shares and has filed a Draft Red Herring Prospectus with SEBI. The Draft Red Herring Prospectus is available on the website of SEBI at www.sebi.gov.in and the respective websites of the BRLMs at www.enam.com and www.kmcc.co.in.   Investors should note that investment in equity shares involves a high degree of risk and for details relating to the same, see the section titled “Risk Factors” of the aforementioned Draft Red Herring Prospectus.” 

This press release is not an offer of securities for sale in the United States or elsewhere.  The shares of Glenmark Generics Limited are not being registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States unless registered under the Securities Act or pursuant to an exemption from such registration.  There will be no public offering of the shares in the United States. 

NOT FOR PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA, JAPAN OR AUSTRALIA 

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