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Unigene's Phase 2 Study of Oral PTH for the Treatment of Osteoporosis in Postmenopausal Women Featured in Bone
Date:12/12/2012

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Phase 2 Study of Oral PTH
The Phase 2 study of oral PTH for the treatment of osteoporosis in postmenopausal women was a multicenter, double blind with respect to placebo, randomized, repeat dose placebo controlled study that included an open label comparator arm of the Forsteo® injectable formulation, and a total of 97 postmenopausal osteoporotic women were enrolled. The primary objective of the Phase 2 study was to assess the change in bone mineral density (BMD) at the lumbar spine, a clinically validated predictor of fracture risk.  The study demonstrated once-daily treatment with 5mg of orally delivered PTH resulted in a significant and clinically relevant mean increase in BMD at the lumbar spine of 2.2 percent (p<0.001) at week 24 as compared to baseline.  Secondary endpoints evaluated biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.

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 drug 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 drug 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 statements relating to whether the oral delivery of PTH is possible from both an efficacy and safety standp
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SOURCE Unigene Laboratories, Inc.
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