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Unigene Announces Positive Top-Line Results of Phase 2 Oral PTH Study for the Treatment of Osteoporosis in Postmenopausal Women
Date:11/9/2011

BOONTON, N.J., Nov. 9, 2011 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced positive top-line results of its Phase 2 clinical study evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in 93 postmenopausal women.  The study achieved its primary endpoint with statistical significance. The Phase 2 study was conducted by Unigene as part of an exclusive worldwide option and licensing agreement with GlaxoSmithKline (GSK).  

The primary objective of the 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 statistically significant mean increase in BMD at the lumbar spine of 2.2 percent (p<0.001) at week 24 as compared to baseline.  

Ashleigh Palmer, President and CEO, stated, "We are delighted to report these positive Phase 2 results from our oral PTH program.  These results further validate Unigene's proprietary oral peptide drug delivery technology and, importantly, we have demonstrated that the oral delivery of PTH is possible, having successfully achieved proof-of-concept.  We now believe we have the opportunity to address an important unmet medical need.  Unigene's Peptelligence™ platform continues to lead the industry, and we are committed to ensuring our distinctive core competence dominates the growing peptide sector, establishing Unigene as the peptide partner of choice."

Secondary endpoints in the Phase 2 study evaluated an open label comparator arm of injectable Forsteo® (teriparatide), an approved treatment for osteoporosis, and placebo to assess the changes in BMD at the lumbar spine at 24 weeks.  The Forsteo® comparator arm showed a
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SOURCE Unigene Laboratories, Inc.
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