Unigene Laboratories, Inc.,  a leader in the design, delivery, manufacture and development of peptide-based therapeutics, announced 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 Cara'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. Cara's phase 1 study is expected to begin in the second half of 2011.

No financial terms were disclosed.

Ashleigh Palmer, Unigene's president and CEO, stated, "Unigene Biotechnologies was created specifically to exploit the potential of our 'Peptelligence' core competence and related technology platforms by providing proprietary solutions to the oral drug delivery and commercial scale manufacturing challenges of other companies' 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 Peptelligence so that it becomes the 'Intel Inside' equivalent for therapeutic peptides." Palmer continued, "We 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."

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.

Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions.

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.