Glenmark Generics announces the settlement of Paragraph IV litigation with GSK

Date: 11 April 2010

 

Press Release                                                                                For Immediate Release

 

Glenmark Generics announces the settlement of Paragraph IV litigation with GSK

Under terms of the agreement, Glenmark will launch a generic version of Malarone® tablets as early as third quarter Calendar Year 2011

Mumbai, India - April 12, 2010: Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), today announced the settlement of litigation pending between Glenmark and GlaxoSmithKline LLC (GSK) over patent actions concerning atovaquone and proguanil hydrochloride 250mg/100mg tablets, the generic version of GSK’s Malarone® tablets.

Under the terms of the Settlement Agreements which are still subject to review by the Federal Trade Commission and the Department of Justice, Glenmark will be able to market and distribute its atovaquone / proguanil 250mg/100mg tablets under a royalty-bearing license from GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances.  Glenmark believes that it is entitled to 180 days of exclusivity with respect to its atovaquone / proguanil 250 mg/100mg tablets as the first generic to file an ANDA for the product.   

GSK currently markets its product as Malarone® in the United States, indicated for the prevention and treatment of malaria. Total U.S. sales as reported by IMS Health for the 12 month period ending December 2009 were approximately USD 56 million.

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.

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 

Download PDF