Nuvelo gets additional orphan drug designation for alfimeprase

By Jennifer Chiou

New York, Nov. 8 - Nuvelo Inc. said it obtained orphan drug designation for lead product candidate alfimeprase from the Committee for Orphan Medicinal Products of the European Medicines Agency.

Alfimeprase is for the treatment of acute peripheral arterial occlusion or "leg attack."

The designation provides sponsors with benefits that include protocol development assistance and a 10-year period of market exclusivity following market authorization.

Nuvelo noted it already obtained orphan drug designation from the Office of Orphan Products Development at the U.S. Food and Drug Administration for alfimeprase.

The drug's phase 3 trial will include up to 700 patients for a randomized, double-blind study.

Based in San Carlos, Calif., Nuvelo is a biopharmaceutical company focused on acute cardiovascular and cancer therapy.

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