Tarsa Therapeutics and Unigene Present Preclinical Data Suggesting Calcitonin May Have Utility in Combination Therapy for the Treatment of Osteoarthritis

PHILADELPHIA, BOONTON, N.J. and BRUSSELS, Sept. 24 /PRNewswire/ -- Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. (OTC Bulletin Board: UGNE) today reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis.  The data are being presented at the 2010 Osteoarthritis Research Society International (OARSI) World Congress in Brussels, Belgium.  Unigene produces Fortical® nasal calcitonin product for the treatment of postmenopausal osteoporosis and Tarsa's oral calcitonin, which is licensed from Unigene, is in a Phase III trial for the treatment of osteoporosis.

The study was designed to identify whether the combination of salmon calcitonin and other recognized and experimental anti-arthritis drugs can produce additive or synergistic effects in reducing collagen degradation in a bovine in vitro collagen matrix model.  The results were reported by Dr. James P. Gilligan, Chief Scientific Officer of Tarsa, and Dr. Nozer Mehta, Vice President, Biological Research and Development at Unigene.

Dr. Gilligan commented, "The impetus for this study is the fact that osteoarthritis is a complex, multi-modal disease, so combination therapy may be the most effective approach to treatment.  We hypothesized that a potentially disease-modifying osteoarthritis drug such as calcitonin given in combination with other anti-arthritic agents might result in additive or synergistic effects."

In the data presented, calcitonin did exhibit synergistic effects in reducing collagen degradation when combined with low doses of each of two other experimental anti-arthritis agents, while none of the agents reduced collagen release on its own at the concentrations used.

Dr. Mehta noted, "While preliminary, these data lend support to the concept that calcitonin may have a role in reducing cartilage degradation and bone loss as part of a combination therapy for treating osteoarthritis.  In addition, in our studies the synergistic effects were achieved using low doses of the compounds.  This type of combination therapy may have the potential to treat osteoarthritis more effectively while reducing the safety concerns associated with higher doses of existing anti-arthritis agents."

The annual OARSI Congress is a global forum for all people interested and involved in osteoarthritis research and treatment: basic scientists from academia and industry, clinical investigators, physicians (radiologists, rheumatologists, orthopaedic surgeons, etc.), allied health professionals and policy makers.  It is being held in Brussels, Belgium September 23-26, 2010.  For more information, visit www.oarsi.org/meetings/10Congress/index.php.

About Tarsa Therapeutics

Tarsa Therapeutics is developing an oral formulation of calcitonin for the treatment of osteoporosis.  Calcitonin is a peptide hormone that inhibits bone resorption, the underlying process that can result in osteoporosis.  Availability of an oral formulation is expected to generate wider use of this established osteoporosis treatment, which currently is available only in injectable and intranasal formulations.  Tarsa's oral calcitonin has generated promising data in Phase II studies, and the ORACAL study, a global Phase III clinical trial, has completed patient enrollment.  Tarsa is based in Philadelphia, PA.  For more information, visit www.tarsatherapeutics.com.

About Unigene Laboratories, Inc.  

Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics.  The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform.  Peptelligence encompasses extensive intellectual property covering delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence.  Core Peptelligence assets include proprietary oral and nasal peptide delivery technologies, and proprietary, high-yield, scalable and reproducible E. coli-based manufacturing technologies.

Unigene's technologies have extensive clinical and partner validation.  The Company's first product to market, Fortical®, a nasal calcitonin product, received FDA approval in 2005 and is marketed in the U.S. by Upsher-Smith for the treatment of postmenopausal osteoporosis.  Pivotal clinical programs include an oral calcitonin licensed to Tarsa Therapeutics, now in Phase 3 testing for the treatment of osteoporosis.  Other validating relationships include an oral parathyroid hormone nearing Phase 2 and licensed to GlaxoSmithKline.  In addition, Unigene has a manufacturing license agreement with Novartis, which is completing three Phase 3 studies of oral calcitonin for the treatment of osteoporosis and osteoarthritis.

For more information about Unigene, please visit http://www.unigene.com.  For information about Fortical, please visit http://www.fortical.com.

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SOURCE Tarsa Therapeutics, Inc.