Israel's Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Japan's Otsuka Pharmaceutical Co. Ltd. have announced an agreement covering Japan for Otsuka to develop and commercialize fremanezumab, Teva’s investigational drug candidate. Fremanezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of migraine, which 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 8.4 million patients suffer from the condition. The highest prevalence rate is among young women, with 20% of cases reported among women in their 30s. 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.
Published by Globes [online], Israel business news - www.globes-online.com - on May 15, 2017
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