Forest Labs to develop new fibromyalgia treatment
NEW YORK Forest Labs will make a new treatment for fibromyalgia available near the end of the month, Forest and licensor Cypress Bioscience announced Monday.
The companies will ship Savella (milnacipran hydrochloride) to wholesalers on April 24, and it will become available at pharmacies starting April 28. The Food and Drug Administration approved the drug in January.
Fibromyalgia is a chronic condition that causes pain in the muscles, ligaments and tendons, as well as tender points and fatigue. It affects about 2% of the population in the United States and is more common in women than in men, according to the Mayo Clinic.
Vertex reports Q1 earnings
CAMBRIDGE, Mass. Vertex Pharmaceuticals ended first quarter 2009 with $869 million in cash, cash equivalents and marketable securities, the company announced Thursday.
The company is conducting a phase 3 study of telaprevir, a protease inhibitor for treating hepatitis C in patients who have not received treatment or for whom other treatments have failed. In March, Vertex started a phase 2a trial of VX-809, a compound designed to treat cystic fibrosis, and it also plans to start trials for the investigational CF drug VX-770 in the United States and Europe.
“With our strong performance in the first quarter, we are well-positioned to drive forward key programs in hepatitis C and cystic fibrosis and to deliver on our 2009 financial projections outlined earlier this year,” Vertex president Matt Emmens said. “Our top priority is to execute on the telaprevir phase 3 program and to prepare for [a new drug application] filing for telaprevir in the second half of 2010.”
Drug maker’s shares fall after HHS requests regulatory filing
NEW YORK A Department of Health and Human Services request that companies bidding on a government contract to provide anthrax vaccines give a regulatory plan to the Food and Drug Administration in 15 days caused shares of one of the companies to fall by 5.5% in afternoon trading on Friday, according to published reports.
The Associated Press reported Thursday that PharmAthene submitted a regulatory filing saying that HHS did not provide sufficient information. The HHS request caused PharmAthene’s shares to fall by 15 cents, to $2.56.
The Annapolis, Md.-based company makes the anthrax vaccine SparVax.