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Print Edition StoriesTuesday, March 9, 2010
ImmunoGen cancer drug granted orphan drug status
By Mass High Tech staff
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ImmunoGen Inc. reports the U.S. Food and Drug Administration and the EU Committee for Orphan Medicinal Products has granted orphan drug status to an ImmunoGen compound used to treat Merkel cell carcinoma (MCC).
The compound, IMGN901, has shown effectiveness in treating MCC, a rare aggressive neuroendocrine cancer of the skin that typically occurs on the head/neck, most often in individuals of European ancestry, according to the company. Under the FDA orphan status, which is intended to encourage development of treatments for conditions that affect fewer than 200,000 people in the U.S., ImmunoGen (Nasdaq: IMGN) has seven years of market exclusivity starting when the drug wins FDA approval. The EU orphan status applies to treatments affecting no more than 5 in 10,000 people and grants 10 years of market exclusivity.
In December, Immunogen announced preliminary Phase 1 testing for its BT-062 cancer therapy produced “encouraging” results that merited a new round of trials featuring a more frequent dosing regimen. The treatment is intended for patients with relapsed and relapsed/refractory multiple myeloma.
In November and December, the company struck separate deals licensing its Targeted Antibody Payload technology to Thousand Oaks, Calif.-based Amgen Inc., for a combined potential of $69 million.
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