Monday, January 28, 2008

Synta, partner GSK win orphan status for skin cancer drug

Synta Pharmaceuticals Corp. of Lexington and British drug giant GlaxoSmithKline PLC report the firms have been granted "orphan" drug incentives from the U.S. Food and Drug Administration to develop a treatment for deadly skin cancer.

The orphan status provides the firms with seven years of market exclusivity for a metastatic melanoma treatment called elesclomol -- which the companies are developing jointly -- if the drug is approved. It also gives the companies tax credits and a reduction in FDA user fees, according to the firms. Orphan status is granted for treatments that treat diseases found in 200,000 or fewer Americans.

Elesclomol is an injected treatment in Phase 3 clinical trials in combination with chemotherapy drug paclitaxel for metastatic melanoma, the firms report. The firms cited the American Cancer Society in saying that metastatic melanoma accounts for 75 percent of U.S. deaths related to skin cancer.

Synta is a biopharmaceutical company focused on developing chemical-based or small molecule drugs for cancer and other diseases. With 141 employees, the company reported a 2006 net loss of $57.3 million with no revenue.