Philadelphia, PA, Boonton, NJ and Brussels, Belgium – September 24, 2010—Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. (OTCBB: 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, visitwww.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.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, including with respect to clinical studies of one of our licensees. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors. These known and unknown risk factors include, but are not limited to: the delay in obtaining or the failure to obtain regulatory approvals for our products and the products of our licensees that may generate royalty and milestone payments to us, our ability to achieve product sales and royalties, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human clinical trials, our dependence on patents and other proprietary rights and the risks associated with patent litigation, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, general economic and business conditions, our history of losses and ability to achieve profitability, litigation and other risk factors discussed in our Securities and Exchange Commission (“SEC”) filings, including our annual report on Form 10-K and our quarterly reports on Form 10-Q. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “potential,” “continue,” and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements. In addition, any statements that refer to expectations, projections, contingencies, goals, targets or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements and are not statements of historical fact. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.
Tarsa Contact:
GendeLLindheim BioCom Partners
Barbara Lindheim
blindheim@bicompartners.com
Unigene Corporate:
William Steinhauer
VP of Finance
973-265-1100
Unigene Media:
Burns McClellan
Justin Jackson
212-213-0006
jjackson@burnsmc.com
or
Michelle Szwarcberg
212-213-0006
mszwarcberg@burnsmc.com