Glenmark Generics Ltd receives Two Tentative Approval from USFDA

Date: 24 December 2009

Glenmark Generics Ltd receives Tentative Approval from USFDA for Pramipexole Dihydrochloride tablets and Atomoxetine Hydrochloride capsules

-         Estimated market size for Pramipexole Dihydrochloride Tablets is USD 487 mn while estimated market size for Atomoxetine Hydrochloride is USD 498 mn

-         Glenmark should be able to launch Pramipexole Dihydrochloride tablets in Oct’2010 or earlier in certain circumstances

December 24, 2009:  Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval for Pramipexole Dihydrochloride tablets, the generic version of Boehringer Ingelheim’s Mirapex® tablets.  

GGI also received tentative approval from the U.S. FDA for Atomoxetine Hydrochloride capsules, the generic version of Lilly’s Strattera®.

The tentative approval for Pramipexole Dihydrochloride tablets is for the 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg strengths. Pramipexole Dihydrochloride tablets generated sales of USD 487 million for the 12 month period ending September 2009, according to IMS Health.   

Atomoxetine Hydrochloride capsules is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and generated USD 498 million in sales for the 12 month period ended September 2009, according to IMS Health.  Glenmark’s tentative approval was granted for the 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.

Based on the tentative approval for Pramipexole Dihydrochloride tablets, Glenmark Generics should be able to launch the product in October 2010 or earlier in certain circumstances.  

The significance of these tentative approvals exemplifies Glenmark’s rapid success over a relatively short period of time. The Company has received ten final and five tentative approvals this calendar year and has well over 40 Abbreviated New Drug Applications (ANDA) pending approval with the U.S. FDA.  

Glenmark’s current marketing portfolio consists of 49 products authorized for distribution in the United States. The Company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.  

  About Glenmark Generics Ltd.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, EU 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 65 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.”

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