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BioVectra Inc. announced today it has signed agreements with Sandoz Inc. of Princeton, New Jersey, for Sandoz to commercialize and market the Abbreviated New Drug Application (ANDA) for Docetaxel for injection, the generic version of Taxotere®, developed by BioVectra.
“The Sandoz team is well-positioned to maximize the opportunity for both companies. We look forward to a successful commercial program and providing an important generic alternative to the market.”
The company has reached commercial marketing and supply agreements with Sandoz Inc (a division of Novartis) to extend specific marketing rights within the U.S. for the drug to Sandoz, and BioVectra believes this is the first filing of a substantially complete ANDA containing a Paragraph IV certification for the product. Under the provisions of the Hatch-Waxman Act, it is expected that 180 days of sole marketing exclusivity will be awarded, once final approval is obtained. The filing of the ANDA took place in June, 2009.
Docetaxel for Injection (Taxotere®) is a clinically well-established anti-mitotic chemotherapy medication, used mainly for the treatment of breast, ovarian, neck, and non-small cell lung cancers. Worldwide sales of Taxotere®, the Sanofi-Aventis brand of the drug, exceed 3 billion USD annually.
http://www.biovectra.com/
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