Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Jul 23 2010

Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) announced today that Novartis and its license partner Nordic Bioscience [the "Sponsor"] have decided to continue the companies' two-year, Phase III Study 2302 assessing safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee. Novartis has a worldwide license to produce recombinant calcitonin under Unigene's patented SecraPep® E. coli manufacturing technology.

“We believe our manufacturing license agreement with Novartis provides strong validation of Unigene's leading position in peptide manufacturing. We look forward to hearing of next steps in the program.”

An independent Data Monitoring Committee (DMC) reviewed and conducted a "futility" analysis of one-year data for all patients enrolled in Study 2302, including both an assessment of safety and efficacy parameters. The DMC concluded there is no reason to stop the study because of safety findings. In addition, the DMC concluded there is no reason to continue the study because of efficacy findings; however, the DMC also determined the final decision whether to continue Study 2302 rests with the study Sponsor. Accordingly, the relevant Health Authorities and Ethics Committees will be informed by the Sponsor about the DMC recommendation and about the decision to continue the study.

Conclusions after these kinds of interim analysis are usually based on whether or not the DMC has seen either major safety concerns, or a significant imbalance in adverse events, or an unsatisfactory efficacy outcome.

Based on a similar one-year futility analysis, the DMC recommended in December 2009 that Novartis and Nordic Bioscience continue a parallel two-year, Phase III Study 2301 in patients with osteoarthritis of the knee. At that time, the DMC also recommended continuation of a two-year, Phase III Study 2303 of oral calcitonin in patients with osteoporosis.

It is currently intended by the Sponsor that the entire clinical program of oral calcitonin in osteoarthritis and osteoporosis will continue, and Novartis and Nordic Bioscience will closely work together to assess next steps once the final data of Study 2301 are available, currently expected to be in 4Q 2010.

Unigene President and CEO Ashleigh Palmer commented, "We believe our manufacturing license agreement with Novartis provides strong validation of Unigene's leading position in peptide manufacturing. We look forward to hearing of next steps in the program."