Emisphere Reports First Interpretable Results on Second Phase III Study

On July 23, 2010, Emisphere Technologies, Inc. reported that Novartis Pharma AG and its license partner Nordic Bioscience A/S provided certain information in connection with their Phase III Study 2302 assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee.

Study 2302, along with its companion Study 2301, incorporates Emisphere’s unique and proprietary Eligen Drug Delivery Technology for the improved oral absorption of salmon calcitonin. Specifically, in July 2010, Novartis informed Emisphere that an independent Data Monitoring Committee conducted a futility analysis of 1-year data for all patients enrolled in Study 2302, including assessments of safety and efficacy parameters. Although the DMC concluded that there was no reason to stop Study 2302 because of safety concerns, there was no reason to continue the study for efficacy. Novartis has informed Emisphere that because of a previously more encouraging futility analysis of Study 2301 (reported by December 9, 2009), Novartis and Nordic Bioscience had decided to continue the study to be able to pool results and compare safety information.

Following completion of Study 2302, Novartis has recently informed Emisphere that it has reviewed the first interpretable results and has advised Emisphere of its top line conclusions as follows: Preliminary analysis of 2-year study data showed both co-primary endpoints and secondary endpoints of the study were not met. Additionally, preliminary analysis of Study 2302 data showed a positive safety profile.

Nordic Bioscience recently presented the results from the 2-year Phase III Study 2301, the companion study to Study 2302, at the Osteoarthritis Research Society International World Congress on Osteoarthritis held September 15-18, 2011, in San Diego. The results were also published in OARSI Abstract No. 64, Volume 19, Supplement 1. Specifically, the OARSI abstract contains the conclusion “twice daily oCT over 2 years resulted in a significant symptom-modifying efficacy in patients with painful knee OA as assessed by WOMAC pain, physical function, and stiffness scores. Although improvement on the primary endpoint of JSW (joint-space width) was not reached, there was an increase in cartilage volume versus placebo, indicating some structure-modifying efficacy.”

Novartis has not provided Emisphere with any further data from either Study 2302 or Study 2301 at this time. Nordic Bioscience and Novartis have indicated that they are going to continue to work together to further analyze and evaluate the results. Additionally, a Phase III study of oral calcitonin in osteoporosis has been completed, and first interpretable results are expected in the fourth quarter of 2011.