BioVectra signs agreements with Sandoz to commercialize and market Docetaxel

Jan 6 2010

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.

While the specific terms of the agreement remain undisclosed, the two companies have been cooperating toward the ANDA filing and preparing for a commercialization strategy together for much of 2009. The partnership utilizes the strengths of Sandoz as a global leader in supplying differentiated medicines such as biosimilars and generic oncology injectables, and BioVectra as a skilled manufacturing and development partner, who was able to undertake an effective technology development program ahead of other potential Paragraph IV filings.

“We at BioVectra are pleased to collaborate with Sandoz on providing the U.S. market with a critical generic option for Docetaxel,” stated Dale Zajicek, Chief Operating Officer for 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.”

BioVectra has previously announced that Taxolog, Inc. has been its technology partner who enabled the use of the IP portfolio from Dr. Robert Holton of Florida State University. The partners were able to successfully cooperate on development and commercialization of proprietary technologies for taxane semi-synthesis out of this technology development agreement.