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Unigene Provides 2012 Business Outlook
Date:1/9/2012

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Tarsa also currently has a Phase 2 osteoporosis prevention trial ongoing.  TAR01-201, is a Phase 2 double-blind study comparing oral recombinant salmon calcitonin to placebo in approximately 120 postmenopausal women who have low bone mass (osteopenia) and are at increased risk of fracture. This proof-of-concept study is evaluating the ability of oral calcitonin to prevent osteoporosis and maintain bone mass in this population.  Tarsa expects to report top-line results from this study in the second half of 2012.

Tarsa expects to file its New Drug Application (NDA) submission schedule to the FDA for OSTORA, in the second half of 2012.

Metabolic Peptide Programs Advancing in Preclinical Development

Unigene's lead proprietary anorexigenic peptide, UGP281, is currently in advanced preclinical development. An anorexigenic peptide is one that diminishes or controls appetite and offers potential therapeutic benefit to morbidly obese patients.

UGP281 is a peptide hormone analog that has shown an acute dramatic reduction in food intake in rat and dog model preclinical studies at low doses. The peptide has been produced by recombinant expression in E. coli and has also been formulated in enteric-coated capsules for oral delivery.

Longer term oral studies with UGP281 in dog models are currently ongoing. Unigene expects to file an Investigational New Drug (IND) application with the FDA and initiate Phase 1 clinical studies before the end of 2012.

On October 6, 2011, Unigene and Nordic Bioscience announced the companies established a Joint Development Vehicle (JDV) to progress up to three of Unigene's internally developed, proprietary calcitonin analogs through Phase 2 proof-of-concept in humans for the treatment of Type 2 diabetes, osteoarthritis and osteoporosis. Unigene and Nordic each own 50% of the JDV.

In exchange for 50% ownership interest in the JDV, Unigene has licensed, on an
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SOURCE Unigene Laboratories, Inc.
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