FDA Approves Second Improvement to Unigene's Calcitonin Manufacturing Process

Apr 29, 2008 - The U.S. Food and Drug Administration (FDA) has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in Fortical(R), Unigene Laboratories, Inc.'s (OTCBB: UGNE, http://www.unigene.com) nasal spray product for the treatment of osteoporosis. This is the second improvement to the production process approved by the FDA this year. The combination of these improvements is expected to increase batch yields of the product by a factor of three.

"We believe that these improvements to our manufacturing process will reduce our future costs and allow us to increase capacity for Fortical," said Dr. Warren Levy, President and CEO of Unigene. "Given the safety concerns reported for certain other osteoporosis products, we believe that the availability of alternative products may become important for osteoporosis sufferers. The global history of calcitonin products has shown that these products are effective with no significant side effects. Also, FDA approval of our improved manufacturing process should provide additional capacity for other peptide products."