Local biotech firm wins OK on cancer drug
Gloucester Pharmaceuticals, a six-year-old Cambridge biotechnology start-up, has won approval from the Food and Drug Administration to market its first drug in the United States.
The drug, called Istodax, treats a rare skin cancer known as cutaneous T-cell lymphoma, or CTCL. Roughly 20,000 people in the United States have the cancer, which affects the immune system. The drug could be made available in January for some patients, Gloucester chief executive Alan Colowick said yesterday.
The company, which has a small staff and used outside consultants for its clinical development, licensed the technology behind Istodax from Japan’s Fujisawa Pharmaceutical Company Ltd. in 2004. Company officials have been talking to larger drug firms about forming a potential partnership to sell Istodax. But they also recently raised $29 million in venture capital from a consortium of investors and may use it to bring the drug to market themselves.
“A number of companies are interested in this drug and a potential partnership,’’ Colowick said, but he added that no deal is at hand.
There are already three drugs on the market to treat CTCL, a form of non-Hodgkin’s lymphoma: Ontak and Targretin, made by Eisai Inc. of Woodcliff Lake, N.J., and Vorinostat, made by pharmaceutical giant Merck & Co. of Whitehouse Station, N.J. Physicians also prescribe drugs approved for other types of cancer to treat the rare disease in many patients.
Istodax, a small molecule drug made in fermentation and administered intravenously, promises longer-lasting responses, Colowick said. “We believe there is a definite unmet medical need,’’ he said. “Many patients with CTCL will cycle through many, many different types of therapies because either they don’t respond to a drug or the response is short-lived.’’
Gloucester, which is backed by five venture capital firms, including Apple Tree Partners of Cambridge, filed its new drug application last January, citing efficacy studies from two clinical studies involving 167 patients. An advisory panel unanimously recommended in September that the FDA approve the drug.
Robert Weisman can be reached at weisman@globe.com. 
