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Osteoporosis

U.S. FDA approves Fortical for postmenopausal osteoporosis

Published in Women's Health Weekly, September 15th, 2005

Unigene Laboratories, Inc., (UGNE) has received approval from the U.S. Food and Drug Administration (FDA) for Fortical calcitonin-salmon (rDNA origin) Nasal Spray, its nasal calcitonin product for the treatment of postmenopausal osteoporosis.

FDA approval triggers the final milestone payment of $4 million under Unigene's exclusive U.S. licensing agreement with Upsher-Smith Laboratories, Inc.

Fortical will be manufactured at Unigene's production facility in Boonton, New Jersey. The final product will be packaged, marketed, and sold in the United States by Upsher-Smith. Unigene will sell the filled product to Upsher-Smith and receive royalties on...

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