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Unigene Provides Update Following Recent EMA Recommendation on Calcitonin-Containing Medicines
Date:7/26/2012

BOONTON, N.J., July 26, 2012 /PRNewswire/ --  Unigene Laboratories, Inc. (OTCBB: UGNE) today announced it has contacted relevant commercial parties to request access to certain European calcitonin product related safety data submitted to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).  The Company understands that it was this data that led to the EMA's recommendation issued on July 19, 2012, which suggests there is evidence of a small increased risk of cancer with long-term use of certain calcitonin medications commercially available in Europe, and calling for a curtailment in the usage of those products.

Ashleigh Palmer, Unigene's President and CEO, stated, "We are extremely surprised by the EMA's recent recommendation concerning certain products containing calcitonin, a therapeutic agent that has been approved for use in Europe since 1973.  It is important that we obtain and study the safety data for the specific European products that were reviewed by the CHMP to better understand the rationale behind the EMA's conclusion."

Unigene is currently evaluating the potential regulatory and commercial impact of the EMA recommendation on calcitonin-containing products currently marketed or under development by its licensees and partners, as well as the resulting financial impact on the Company's future business operations.

The Company also reported that the results of the Phase 3 ORACAL trial demonstrating the safety and efficacy of Tarsa Therapeutics' oral calcitonin in the treatment of postmenopausal osteoporosis were published yesterday in the Journal of Bone and Mineral Research*.  Th
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SOURCE Unigene Laboratories, Inc.
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