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|May 15, 2017 8:02 a.m.|
|Otsuka and Teva Sign Licensing Agreement for Japan on Prophylactic Migraine Drug Candidate Fremanezumab (TEV-48125)|
The annual prevalence of migraine in
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.
About the Agreement
With the agreement consummated, Otsuka is to pay Teva a lump-sum payment
Gianfranco Nazzi, president & CEO growth markets at
About Fremanezumab (TEV-48125)
Fremanezumab is a monthly subcutaneous injection that is under development for the prevention of migraine, with clinical trials conducted in chronic and episodic migraine as well as chronic and episodic cluster headache. It is thought to prevent migraine by selectively binding to CGRP ligand, a well-validated target in migraine. The effectiveness and safety of four dose levels of fremanezumab were previously studied in phase IIb, placebo-controlled, double-blind trials (about 300 participants) for the prevention of recurrent, episodic migraine and chronic migraine.
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical is a subsidiary of
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka at www.otsuka.co.jp/en/. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on Twitter at @OtsukaUS.
1 Sakai F, Igarashi H. Prevalence of migraine in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential the research, development and commercialization of TEV-48125 (fremanezumab), which are based on Teva’s management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
Teva Pharmaceutical Industries Ltd.