Otsuka Pharmaceutical Co and Teva Pharmaceutical Industries, Ltd, have announce an agreement covering Japan for Otsuka to develop and commercialize Teva’s investigational drug candidate fremanezumab (TEV-48125), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of migraine. Fremanezumab is administered monthly as a subcutaneous injection. Through the agreement, Otsuka secures exclusive rights in Japan to fremanezumab, which Teva is globally developing in other countries.

The annual prevalence of migraine in Japan is 8.4% of adults and approximately 8.4 million patients suffer from the condition. The highest prevalence rate is among young women, with approximately 20% of cases reported among women in their 30s.*1 Acute as well as preventive treatments exist for migraine, but there is an unmet need for targeted, preventive treatments.

In global Phase IIb studies conducted by Teva for episodic and chronic migraine, all doses achieved their primary and secondary study endpoints. The data indicated a significant reduction in both the number of monthly cumulative headache hours (primary endpoint in chronic migraine), and the number of migraine days (primary endpoint in episodic migraine), relative to baseline. No treatment-related serious adverse events were reported with the use of fremanezumab. Common adverse events observed in clinical trials included mild injection-site pain or erythema and pruritus.

With the agreement consummated, Otsuka is to pay Teva a lump-sum payment of $50 million. Milestone payments will be made upon filing and regulatory approval in Japan and then upon achievement of specified revenue targets. Future clinical trials in Japan will be carried out and funded by Otsuka. In addition, Otsuka holds exclusive sales rights and will pay royalties on revenues to Teva.

Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd. commented, "Through this agreement, we aim to leverage our core strengths in the areas of neurology and psychiatry. I'm confident that this new therapy, advanced to this development stage by Teva, holds significant potential as a future new option in an area with high patient needs in Japan."

Gianfranco Nazzi, president & chief executive officer growth markets at Teva Pharmaceuticals Industries, noted, “We have seen very promising preliminary results for fremanezumab in our Phase IIb studies for both chronic and episodic migraine. We believe the promise shown in these investigational trials represents significant hope for patients suffering from debilitating migraines, and we look forward to bringing this therapy to patients in Japan in collaboration with Otsuka Pharmaceutical Co”