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Unigene Laboratories Inc.

FDA Compliance

FDA Approves Improvement to Unigene’s Manufacturing Process

Published: Tuesday, February 26, 2008 - 23:00

(Unigene Laboratories Inc: Fairfield, New Jersey) -- The U.S. Food and Drug Administration has approved a modification for a key enzyme, the first of two proposed improvements for Unigene Laboratories Inc.’s patented manufacturing process for calcitonin, the active ingredient in Fortical, a nasal spray product for the treatment of osteoporosis. The FDA is still reviewing a second improvement to the production process that, if approved, is expected to advance batch yields of the product by a factor of three.

"We believe that these improvements to our production process will increase efficiency and productivity at our manufacturing facility," says Dr. Warren Levy, president and CEO of Unigene. "In addition to reducing our manufacturing costs, these improvements should enable us to more easily increase our capacity if Fortical demand increases. We believe that the comparability in efficacy of many osteoporosis products, as reported last month in a study commissioned by the Department of Health and Human Services, along with the safety concerns reported for several of the leading osteoporosis products, may ultimately create a larger commercial opportunity for calcitonin-based therapies."

The leading osteoporosis products fall within a class of drugs called bisphosphonates. Although they are effective in reducing the incidence of fracture and in preventing bone loss, they have been associated with osteonecrosis, an infrequent but severe condition. The FDA has also announced that it’s conducting a safety review of this class of drugs regarding a possible increased risk of atrial fibrillation, an established risk factor for stroke. Most recently, the FDA issued a new warning that bisphosphonates may be associated with severe joint pain.

For more information, visit www.unigene.com/investor_relations/news_detail.php?reqid=1097438


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Unigene Laboratories Inc.