Solvay vows to work with FDA on approval of tedisamil
WASHINGTON Solvay Pharmaceuticals said it will continue to work closely with the Food and Drug Administration to fully address the questions raised by members of the Cardio-Renal Advisory Committee about its tedisamil drug, according to published reports.
The committee held a meeting to consider the tedisamil drug as a treatment for rapid conversion of recent onset atrial fibrillation to normal sinus rhythm. The committee voted against approval of tedisamil at the time, requesting that Solvay Pharmaceuticals provide additional information.
“Although we are disappointed with today’s vote, we remain committed to working with the FDA to determine appropriate next steps in the review of this drug application,” said Laurence Downey, chief executive of Solvay Pharmaceuticals.
The company said it expects action from the FDA on or before Jan. 19.
FDA approves Teva’s generic Trileptal
The Food and Drug Administration has granted final approval to Teva for its application to market a generic version of Trileptal, by Novartis, for the treatment of epilepsy.
The generic, oxcarbazepine, will be available in 150, 300 and 600 mg tablets. Teva will begin shipping the drug in the near future.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
The brand product had annual sales of approximately $690 million in the United States for the twelve months ended Sept. 30, 2007, based on IMS sales data.
Biogen’s lack of buyer interest triggers stock price dive
CAMBRIDGE, Mass. Biogen has reported that after two months of looking for a potential buyer, it has turned up no serious offers, which led to a 27 percent drop in the company’s shares, according to the Wall Street Journal.
Biogen said in a statement that it “did not receive any definitive offers to purchase the company” and would abandon exploration of a sale. Within a few minutes of the announcement, Biogen lost nine months of increasing business by buyout rumors.
Pharmaceutical firms may have been discouraged by Biogen’s high price—its market value had grown to $25 billion after the company announced its intention to sell. Last month, Sanofi-Aventis’ chief executive called Biogen’s price “a little high.”
Biogen has three main drugs on the market—Avonex and Tysabri for multiple sclerosis and Rituxan for cancer and rheumatoid arthritis. Some analysts said uncertainties about the future of the drugs were too great for buyers. Tysabri has been linked to a rare brain disorder, prompting close regulatory scrutiny.
The stock price fell from $75.88 to $55.50 on the Nasdaq Stock Market.