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Unigene Reports Third Quarter 2011 Financial Results
Date:11/9/2011

ORACAL study was a Phase 3 multinational, randomized, double-blind, double-dummy, placebo-controlled trial of OSTORA™ compared to placebo and to commercially available, synthetic salmon calcitonin administered by nasal spray. The primary efficacy endpoint was the percentage change in lumbar spine bone mineral density (BMD) after one year of treatment. The trial enrolled 565 postmenopausal women with established osteoporosis in six countries.

Unigene is awaiting details from Tarsa regarding the timing of its New Drug Application (NDA) submission schedule to the U.S. Food and Drug Administration (FDA) for OSTORA, as well as its potential exit transaction.

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.

Metabolic Peptide ProgramsUnigene'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 is on track to file an Investigational New Drug (IND) application with the FDA and initiate Phase 1 clinical studies in the first half of 2012.

On October 6, 2011, Unigene and Nordic Bioscience anno
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SOURCE Unigene Laboratories, Inc.
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