DMC recommends Novartis and Nordic Bioscience to continue oral calcitonin Phase III studies

Dec 11 2009

Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) 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.”