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Unigene Comments on FDA Advisory Committee Review of Salmon Calcitonin
Date:3/6/2013

BOONTON, N.J., March 6, 2013 /PRNewswire/ -- Unigene Laboratories, Inc. (PINK: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today commented on the outcome of the Food & Drug Administration (FDA) Advisory Committee Meeting held on March 5th, 2013 to discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer. The Advisory Committee concluded via a 12-9 vote that the benefits of calcitonin products, including Fortical®, do not outweigh the potential risks associated with their use and, as a result, should not continue to be broadly marketed. Unigene is the manufacturer of Fortical Nasal Spray, a calcitonin containing product indicated for the treatment of osteoporosis that is distributed in the USA by Upsher Smith Laboratories, Inc. 

Additionally, the Advisory Committee recommended via a 20-1 vote that fracture prevention data should be required for the approval of new oral calcitonin products in development for osteoporosis prevention and treatment.  This recommendation could impact Unigene's licensee, Tarsa Therapeutics. Tarsa Therapeutics is currently developing an oral calcitonin tablet for the treatment of postmenopausal osteoporosis.

Ashleigh Palmer , Unigene's Chief Executive Officer, stated, "It is our understanding that the FDA will now take the Advisory Committee's recommendations under consideration.  Restricting the use of calcitonin drugs has been a possibility since last year's negative EMA ruling on calcitonin containing products.  Currently, we are evaluating how the specific recommendations from yesterday's Advisory Committee Meeting are likely to affect Unigene.  However, to be clear, they are certain to have a materially adverse impact on the Company's financial situation an
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SOURCE Unigene Laboratories, Inc.
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