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Sanofi-aventis U.S. to Acquire Oral Chronic Lymphocytic Leukemia Treatment

Posted on: Monday, 11 May 2009, 15:30 CDT

BRIDGEWATER, N.J., May 11 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that it has acquired from biotechnology company Antisoma plc the U.S. commercial rights to Oforta(TM) (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.

About Oforta

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.

About CLL

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.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

For more information, www.sanofi-aventis.us or www.sanofi-aventis.com.

U.S. Contact Lisa Buffington 908-981-6569 Lisa.Buffington@sanofi-aventis.com

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE sanofi-aventis

Source: PR Newswire

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