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Unigene Announces Manufacturing and Clinical Supply Agreement with Cara Therapeutics for Phase 1 Study of Novel Kappa Receptor

^{Published on 2011-05-19 05:11:01 - Market Wire}
 

BOONTON, N.J.--([ BUSINESS WIRE ])--Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the Company signed a Clinical Manufacturing Services Agreement with Cara Therapeutics, Inc. Unigene will use its validated, proprietary peptide manufacturing technology to provide clinical supply material for Caraa™s Phase 1 study of investigational drug, CR845, a peripherally acting kappa opioid agonist being developed for the treatment of both acute and chronic pain. Caraa™s Phase 1 study is expected to begin in the second half of 2011.

No financial terms were disclosed.

Ashleigh Palmer, Unigenea™s President and CEO, stated, aUnigene Biotechnologies was created specifically to exploit the potential of our 'Peptelligencea"' core competence and related technology platforms by providing proprietary solutions to the oral drug delivery and commercial scale manufacturing challenges of other companiesa™ therapeutic peptides. We are pleased to have had early success with Cara via the results of a feasibility study, then to be selected as their partner of choice to manufacture its Phase 1 study clinical trial material, and believe this transaction represents further validation of our oral delivery technology. The goal of our Biotechnologies strategic business unit is to deploy Peptelligencea" so that it becomes the 'Intel® Inside' equivalent for therapeutic peptides.a Palmer continued, aWe remain focused on and committed to building a diverse portfolio of highly targeted project proposals, and we have had several enter feasibility studies, with others still expected to do so. We anticipate additional feasibility studies will be commissioned throughout the remainder of this year. While not all of the feasibility studies we initiate will materialize into formal partnerships or license agreements, we are confident that we will establish a viable portfolio of new opportunities to ensure long-term success for this compelling and vibrant strategic business unit.a

About CR845

CR845 is a highly selective, peripherally restricted kappa opioid receptor agonist currently in Phase 2 clinical development as an IV formulation for the treatment of post-operative pain. CR845 represents a new class of peripherally acting opioid analgesic which activates peripheral opioid receptors located on sensory nerves and immune cells, but not in the brain. Consequently, CR845 acts to produce analgesia without the central nervous system (CNS) side effects of sedation, respiratory depression, and abuse liability. CR845 has exhibited an excellent safety profile in over 140 human subjects exposed to date.

About Cara Therapeutics, Inc.

Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. In addition to CR845, Caraa™s current pipeline includes near-term clinical development candidates within multiple proprietary classes of peripherally restricted cannabinoids with preclinical analgesic and anti-inflammatory activity. Cara also plans to develop entirely novel classes of analgesics that emerge from its proprietary GPCR DimerScreena" technology

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 Peptelligencea" 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.

Unigenea™s technologies have extensive clinical and partner validation. The Companya™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. Unigene licensed its oral calcitonin program to Tarsa Therapeutics and expects an NDA filing with the FDA before year end. The Company has a worldwide licensing agreement with GlaxoSmithKline for its parathyroid hormone product candidate currently in Phase 2. 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.