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 recombinant 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 robust E. coli-based manufacturing technologies, including peptide amidation.
In June 2010, Ashleigh Palmer, an experienced biopharmaceutical turnaround executive was appointed President and Chief Executive Officer. In the third quarter of 2010, the Company completed a comprehensive business audit and situational analysis resulting in a new strategy for the Company, an organizational realignment with the creation of two highly focused strategic business units, Unigene Biotechnologies and Unigene Therapeutics, and the appointment of a new executive leadership team.
Unigene is exclusively focused on peptide therapeutics. Peptides are a rapidly growing therapeutic class with more than 130 programs currently in active development throughout the industry. To date, more than fifty peptide-based therapeutics have reached the market. Our goal is to see our Peptelligence(TM) platform, which represents a distinctive set of capabilities and assets, incorporated into as many peptide programs as possible as they advance through development towards commercialization. In 2011, the top 15 selling peptide drugs totaled $27 Billion.
Peptelligence™ encompasses extensive intellectual property covering drug delivery and manufacturing technologies, peptide research and development expertise, and proprietary know-how. Our core Peptelligence™ assets include proprietary oral and nasal peptide drug delivery technologies, and proprietary, high-yield, scalable and robust recombinant manufacturing technologies.
We are focusing our Unigene Therapeutics pipeline on metabolic with significant unmet medical and socioeconomic needs. We also intend to focus our Unigene Biotechnologies business unit on generating near-term fee-for-service revenues and longer-term milestone payments and royalties by customizing delivery and manufacturing solutions for novel therapeutic peptides.
Unigene’s technologies have extensive clinical validation. The Company’s first product to market, Fortical®, a nasal calcitonin product, received FDA approval in 2005 and is marketed by Upsher-Smith for the treatment of postmenopausal osteoporosis. Pivotal clinical programs include OSTORA™, an oral calcitonin licensed to Tarsa Therapeutics that has achieved all of the efficacy endpoints in a pivotal Phase 3 trial, and also indicated that the safety profile of OSTORA™ did not substantially differ from nasal calcitonin or placebo. Unigene’s reported positive, statistically significant Phase 2 results of it oral parathyroid hormone currently in Phase 2, having achieved its primary endpoint. In addition, Unigene reported positive data from preclinical studies in rats and dogs for its lead proprietary anorexigenic peptide, UGP281 for the treatment of morbid obesity.
Unigene is committed to realizing the potential of its proprietary technology assets and the Company’s advanced and broad pipeline of novel peptides focused on metabolic diseases.