Positive Phase 3 results from Tarsa's ORACAL study validates Unigene's oral peptide drug delivery technology

Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the statistically significant top-line results released by its licensee, Tarsa Therapeutics, validate its proprietary oral peptide drug delivery technology. The ORACAL study achieved its primary endpoint and the results support Tarsa's plans for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) targeted before the end of 2011. The study design and endpoints were agreed with the FDA through a formalized Special Protocol Assessment (SPA) process. Tarsa also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2012.

“The positive Phase 3 results confirm our belief that Unigene's oral drug delivery technology leads the industry. Our internally-developed calcitonin tablet formulation now has the potential to be the first oral calcitonin to reach the market and will provide patients with a once-a-day easy to use osteoporosis therapy.”

Ashleigh Palmer, Unigene's President and Chief Executive Officer, commented, "The positive results from the Phase 3 oral calcitonin trial represent the second game-changing event for the New Unigene since launching our turn-around strategy last quarter! The successful outcome of this study not only validates our propriety oral peptide delivery technology and state-of-the-art recombinant manufacturing capabilities, but highlights our overall competence in the peptide sector. Our mission is to become nothing less than the pre-eminent peptide powerhouse."

The ORACAL study is a Phase 3 multinational, randomized, double-blind, double-dummy placebo-controlled trial of oral recombinant salmon calcitonin compared to commercially available synthetic salmon calcitonin administered by nasal spray. The ORACAL study's primary endpoint was the percent change in lumbar spine bone mineral density (BMD) after one year of treatment. The results of the study demonstrated that oral salmon calcitonin was significantly superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing BMD at the lumbar spine after one year of treatment. The trial enrolled 565 postmenopausal women with established osteoporosis in six countries. The trial also assessed the tolerability of oral calcitonin, which was similar to that of calcitonin administered by nasal spray and to placebo. Tarsa expects that the full data from the study will be presented in a prestigious, peer-reviewed forum in the second half of 2011.

Dr. Nozer Mehta, Vice President, Biological Research and Development stated, "The positive Phase 3 results confirm our belief that Unigene's oral drug delivery technology leads the industry. Our internally-developed calcitonin tablet formulation now has the potential to be the first oral calcitonin to reach the market and will provide patients with a once-a-day easy to use osteoporosis therapy." Dr. Mehta continued, "Furthermore, these results give added confidence for our ongoing development programs and feasibility studies using our propriety oral drug delivery technology."

Calcitonin is approved for the treatment of postmenopausal osteoporosis, but its use has been limited by the fact that it is currently available only in intranasal and injectable forms. The efficacy of this oral calcitonin tablet formulation in delivering the desired blood levels of calcitonin and reducing levels of biomarkers of bone resorption has been demonstrated by Unigene in prior clinical studies.