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Oncophage receives orphan drug status.(Brief Article)
2002 JUL 3 - (NewsRx.com & NewsRx.net) -- Antigenics, Inc., (AGEN) announced that the U.S. Food and Drug Administration (FDA) has granted the company's personalized cancer vaccine Oncophage (HSPPC-96) orphan drug status for the treatment of renal cell carcinoma.
This designation gives Antigenics, among other benefits, potential market exclusivity in renal cell carcinoma - the most common type of kidney cancer - for seven years from FDA marketing approval.
"This designation is extremely gratifying for us, as it clearly supports our aim of developing superior treatments for underserved markets," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "As a company, we strive to create new treatment options to effectively address enormous unmet medical needs - a goal we believe can be accomplished with Oncophage in renal cell carcinoma."
The orphan drug program is intended to encourage research, development, and approval of products that affect fewer than 200,000 patients in the United States. In addition to seven years of market exclusivity following marketing approval, orphan drug status provides tax incentives for up to 50% ...
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Source: HighBeam Research, Oncophage receives orphan drug status.(Brief Article)