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FDA Approves Fortical (calcitonin-salmon), Unigene's Nasal Calcitonin Product for Postmenopausal Osteoporosis
FAIRFIELD, N.J. -- August 15, 2005 -- Unigene Laboratories, Inc. has received approval from the U.S. Food and Drug Administration ("FDA") for Fortical® calcitonin-salmon (rDNA origin) Nasal Spray, its patented 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 Upsher-Smith's sales.
"We are understandably excited to receive FDA approval for our first pharmaceutical product in the U.S.," commented Dr. Warren Levy, President and CEO of Unigene. "This is a pivotal accomplishment for any company in our industry and it will provide the rapidly growing population of postmenopausal osteoporosis sufferers with an additional option for managing the disease. We are confident that Upsher-Smith's enthusiasm and commitment to the product will give us the best opportunity to realize Fortical's potential. We expect that the revenues generated from sales of Fortical will allow us to strengthen our financial position and expand our activities into new applications of our patented peptide manufacturing and oral delivery technologies."
"We are thrilled that the FDA has approved Unigene's Fortical as an important therapy for the osteoporosis market, which in 2004 grew nearly 18% to reach $4 billion," said Mark Evenstad, Upsher-Smith President and Vice Chair. "We look forward to engaging our marketing and distribution expertise to help make this important calcitonin product available to the millions of Americans affected by osteoporosis."
Fortical Indication
Fortical is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women.
SOURCE: Unigene Laboratories, Inc.
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