Sanofi-aventis to acquire Oforta, oral chronic lymphocytic leukemia treatment

Sanofi-aventis U.S. announced today that it has acquired from biotechnology company Antisoma plc the U.S. commercial rights to Oforta (fludarabine phosphate film-coated tablets), an oral B-cell chronic lymphocytic leukemia (CLL) drug. Oforta is currently approved in the United States for use as a second-line therapy to treat adults with B-cell CLL.

"We are extremely pleased to add Oforta to our existing oncology portfolio, and believe it represents an exciting opportunity for sanofi-aventis U.S.," said John Harrington, Vice President and Head of the Oncology Business Unit at sanofi-aventis U.S. "Sanofi-aventis is a company committed to identifying and exploring new treatment options for patients facing serious diseases, such as CLL. This agreement further supports our efforts to help patients and complements our strong heritage of providing therapies to treat cancer."

Antisoma currently licenses certain rights and purchases Oforta from Bayer Schering Pharma AG. As part of this transaction, sanofi-aventis U.S. will acquire these agreements.

Oforta is a nucleoside analogue designed to prevent cancer cells from dividing by inhibiting DNA synthesis. Oforta was granted accelerated review and later received approval from the U.S. Food and Drug Administration (FDA) in December 2008 to treat adult patients with B-cell CLL whose disease has not responded to, or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. Oforta is an orally administered tablet formulation of fludarabine phosphate.

Oforta is indicated as a single agent for the treatment of adult patients with B-cell CLL whose disease has not responded to, or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. Studies demonstrating clinical benefit such as prolongation of survival or relief of symptoms have not been performed. Studies providing a direct comparison of the clinical efficacy and safety of orally administered fludarabine phosphate relative to intravenously administered fludarabine phosphate have not been performed. The most common adverse reactions include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, infection, and nausea and vomiting. Serious opportunistic infections have occurred in patients with CLL treated with fludarabine phosphate.

CLL is a slow-growing cancer of the white blood cells and bone marrow, which arises predominantly in older age groups (the majority of people with CLL are at least 50 years of age). According to the Leukemia & Lymphoma Society, CLL is the most prevalent leukemia -- with approximately 15,000 new cases diagnosed in 2008. An estimated 90,000 people are living with CLL today. More than 95 percent of all CLL cases have B-cell involvement.