Unigene's Proprietary Peptelligence™ Platform Used to Commence Cara Therapeutics Phase 1 Clinical Trial of Oral Novel Peripherally-Acting Kappa Opioid Agonist

BOONTON, N.J., Nov. 30, 2011 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that Cara Therapeutics commenced the Phase 1 study of its oral proprietary peptide-based, investigational drug, CR845, a novel peripherally-acting kappa opioid agonist in healthy volunteers. CR845 oral capsules were formulated using Unigene's validated, proprietary peptide manufacturing technology under a Manufacturing and Clinical Supply Agreement established in May 2011. 

Ashleigh Palmer, Unigene's President and CEO, commented, "The commencement of Cara's Phase 1 study of CR845 is the first clinical study initiated as a result of launching our new strategy a year ago and further validates our mission to deploy Peptelligence™ into as many oral peptide development programs as possible.  With seven feasibility studies ongoing or completed, we believe we are well positioned to build a diverse portfolio of highly targeted project proposals from which we plan to generate near-term revenue from feasibility studies and service fees, while establishing a solid foundation for the potential of licensing agreements with high-value milestones and royalties."

"Initiation of this Phase 1 trial represents an important advancement in the clinical potential of CR845 and will provide the basis for developing the drug beyond the treatment of acute pain in a hospital setting," said Frederique Menzaghi, V.P. of R&D at Cara Therapeutics. "There remains a significant unmet need among chronic pain patients for an effective analgesic without the debilitating or dangerous side-effects of currently used narcotic analgesics and NSAIDs. We believe that an oral formulation of CR845 has the potential to provide an effective and safer option for the treatment of chronic pain."

About CR845

CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain.  In a previous randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy.  In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. A multicenter double-blind, randomized, placebo-controlled 200-patient Phase II trial is ongoing to evaluate the efficacy and safety of intravenous CR845 when administered both pre- and post-operatively in women undergoing laparoscopic hysterectomy. Analysis of this trial is expected in 1Q'12.  To date, more than 150 human subjects have been exposed to CR845 with no cases of the dysphoria or hallucinations that have been reported with centrally-acting kappa opioids.  For more information visit: www.caratherapeutics.com.

About Cara Therapeutics

Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.

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.

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.

Investor Contact:
Unigene Laboratories, Inc.
Jenene Thomas
VP, Investor Relations and Business Administration
973-265-1107
[email protected]

Media Contact:
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SOURCE Unigene Laboratories, Inc.