Bradley introduces first new topical wart treatment in ten years
FAIRFIELD, N.J. Bradley Pharmaceuticals today announced the launch of its new drug, Veregen ointment 15%. The drug is used as a topical treatment for external genital and perianal warts in patients 18 years and older.
Veregen is the first botanical drug approved for prescription use in the U.S. and is patented through 2017, with additional applications pending which, if approved, would extend patents beyond 2020. The active ingredient in Veregen is sinecatechins, a proprietary mixture of 8 catechins, the primary phenols found in green tea leaves. Veregen is the first new prescription treatment for external genital warts in ten years.
In two Phase III studies, Veregen proved effective in clearing both baseline and newly emerging external genital and perianal warts, with complete clearance in 53.6 percent of all patients studied who received Veregen. Veregen also demonstrated low recurrence rates during these trials. When treated with Veregen, only 6.8 percent of the patients experienced recurrence.
External genital warts are one of the most common and fastest spreading venereal diseases worldwide. More than 1 million new cases are seen each year in the U.S. and nearly 1.4 million sexually active adults have visible genital warts at any point in time.
The drug will begin shipping to wholesalers and will be available in drugstores within a few weeks.
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.