FDA Approves Fortical, Unigene's Nasal Calcitonin Product for Postmenopausal Osteoporosis
Monday August 15, 7:00 am ET
Unigene to Receive $4 Million Milestone Payment from Upsher-Smith
FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 15, 2005--Unigene Laboratories, Inc. (OTCBB:UGNE - News) 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.
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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.
Conference Call Details
Unigene will host a conference call on August 15, 2005 beginning at 2:00 P.M. EDT to discuss the FDA approval of Fortical®.
Unigene invites all those interested in hearing management's discussion of the FDA approval of Fortical to join the call by dialing 1-888-802-2266 for participants in the United States and 1-913-312-1270 for international participants and entering access code 4204125 when prompted. A replay will be available for 45 days after the call and can be accessed by dialing 1-888-203-1112 for participants in the United States and 1-719-457-0820 for international participants and entering access code 4204125 when prompted.
About Unigene
Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Unigene has licensed its oral PTH technology to GlaxoSmithKline. Unigene's patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 882-0860 or visit www.unigene.com.
About Upsher-Smith
Upsher-Smith Laboratories, Inc. is a fully integrated pharmaceutical company that manufactures and markets prescription pharmaceutical, OTC and cosmetic products. Upsher-Smith is also actively involved in licensing innovative compounds that are currently in clinical development. For more information about Upsher-Smith Laboratories, call (800) 654-2299 or visit www.upsher-smith.com. |
