FDA Approves Improvement to Unigene’s Calcitonin Manufacturing Process

FAIRFIELD, N.J.--(BUSINESS WIRE)--Unigene Laboratories, Inc. (OTCBB: UGNE) reported that the US Food and Drug Administration (FDA) approved a modification for a key enzyme, the first of two proposed improvements for its patented manufacturing process for calcitonin, the active ingredient in Fortical^®, Unigene’s 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 improve 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”

“We believe that these improvements to our production process will increase efficiency and productivity at our manufacturing facility,” commented 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 is 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.

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. Fortical^®, Unigene’s nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical^® to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. 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 [phone] or visit www.unigene.com. For information about Fortical, visit www.fortical.com.

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