ImmunoGen cancer treatment receives ‘orphan drug’ status from US, European regulators
By APMonday, March 8, 2010
ImmunoGen cancer drug gets ‘orphan drug’ status
WALTHAM, Mass. — ImmunoGen Inc. said Monday the Food and Drug Administration and European regulators gave the company’s potential cancer drug IMGN901 “orphan drug” status.
Orphan drug status is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives in the U.S. include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits. European incentives include similar benefits, with 10 years of market exclusivity.
The special designation covers IMGN901’s use as a treatment for Merkel cell carcinoma, which is a rare type of aggressive cancer that develops beneath the skin.
Shares of Immunogen rose 38 cents, or 5.2 percent, to $7.75 in after-hours trading after rising 27 cents, or 3.8 percent, to close at $7.37 during the regular trading session.
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