Synta, Glaxo skin drug gets orphan status
Synta Pharmaceuticals Corp. and British partner GlaxoSmithKline PLC said today that the Food and Drug Administration granted orphan drug status to their experimental skin cancer drug elesclomol, and Synta's stock soared in premarket trading.
Shares of Lexington, Mass.-based Synta jumped $1.15, or 17.6 percent, to $7.69 in premarket trading.
Orphan drug status is designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases, which affect fewer than 200,000 people in the United States.
The designation also entitles the companies to seven years of market exclusivity for elesclomol for this disease.
In November 2006, elesclomol received "fast track" designation from the FDA for development in metastatic melanoma, or skin cancer. Because the drug was fast tracked, the company can submit clinical trial data to the agency as it becomes available, and receive feedback, rather than having to wait to submit it all at once.
Elesclomol is being developed under a global collaboration agreement between Synta and Glaxo.
(AP)
