Intas Pharma Announces Settlement and License Agreement With Roche for XELODA®

AHMEDABAD, India, June 25, 2013 /PRNewswire/ --

Intas Pharmaceuticals Ltd. and its wholly owned subsidiary Accord Healthcare Inc., today announced that it has entered into a settlement and license agreement with Hoffmann-La Roche Inc. that will resolve pending patent litigation related to XELODA^® Tablets, 150 mg and 500 mg, known generically as Capecitabine Tablets. This product is an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers.  

XELODA^® Tablets had U.S. sales of approximately $706.2 million for the 12 months ending Dec 31, 2012, according to IMS Health.

Hoffmann-La Roche Inc. had filed patent infringement suit against Accord Healthcare and Intas Pharmaceuticals Ltd. following Accord's submission to the U.S. Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of XELODA^® Tablets.

As part of the agreement, Hoffman La Roche Inc. has granted Accord a license to enter the U.S. market with a generic version of XELODA^® Tablets ahead of its exclusivity period. Pursuant to the agreement, pending litigation would be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

About XELODA

XELODA^®, an oral tablet formulation of capecitabine, is approved in U.S. for the treatment of metastatic breast and colorectal cancers. It is available in dose strengths of 150 and 500 mg.

About Intas Pharmaceuticals Limited:

Intas Pharmaceuticals Limited is a leading vertically integrated Indian pharmaceutical company committed on delivering affordable and innovative pharmaceutical solutions. Its operation range from API to formulation development to large-scale commercial manufacturing to cater to global requirements In the domestic market Intas has a leading presence in chronic therapeutic segments and is currently ranked 12^th largest company. Intas also has extensive presence in more than 60 countries worldwide with robust sales, marketing and distribution infrastructure in highly regulated markets like North America, Europe, South Africa, Australia and New Zealand etc. For the financial year ending March 2013, company has recorded turnover exceeding USD 650 mn. The company has a revenue growth of ~25% CAGR over the last 6 years. www.intaspharma.com

About Accord Healthcare Inc:

Accord Healthcare, Inc is the wholly owned subsidiary of Intas in the US. Accord has been servicing the needs of the US healthcare industry since 2009. Its US portfolio consists of about 30 approved oral solids and injectable prescription medicines and 38 awaiting USFDA approval. Accord is now the second largest Indian player in the US generic injectable space.

Primary Media Contact: Pritesh Trivedi, [email protected], 91-97272-60309

Secondary Media Contact: Gaurang Darji, [email protected], 91-99250-38960