Independent Advisory Committee Recommends Continuation of Phase III Oral Calcitonin Studies For Osteoporosis And Osteoarthritis

Unigene Laboratories, Inc. (OTCBB: UGNE) announced that an independent Data Monitoring Committee (DMC) has recommended that Novartis and its partner Nordic Bioscience proceed as planned with their ongoing oral calcitonin Phase III studies for osteoporosis and osteoarthritis.



Its recommendation is based on the committee’s recently completed “futility” analysis of the data obtained from all patients enrolled for at least twelve months in these studies.  That analysis included an assessment of both safety and efficacy parameters.  It is the committee’s opinion that there are no major or unexpected safety concerns and it unanimously recommends to proceed with the studies to evaluate the efficacy and safety profile of oral calcitonin as planned.



“The report of the DMC is an important benchmark in the conduct of these trials and it provides the first preliminary indication of the drug’s performance,” commented Dr. Ronald S. Levy, Executive Vice President of Unigene Laboratories, Inc.  “Unigene has a vested interest in the success of these studies both from a milestone and a royalty perspective, and we are encouraged by this committee’s recommendation.”



About Unigene

Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs.  Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies.  Fortical®, Unigene’s nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in 2005.  Unigene has licensed the U.S. rights for Fortical to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. Unigene’s patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin and PTH analogs. Unigene’s patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics.  For more information about Unigene, call (973) 265-1100.  For information about Fortical.

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