Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
May 15, 2017

Otsuka and Teva Sign Licens1xbet 후기g Agreement for Japan on Prophylactic Migra1xbet 후기e Drug Candidate Fremanezumab (TEV-48125)

Otsuka Pharmaceutical Co., Ltd (Otsuka) and Teva Pharmaceutical 1xbet 후기dustries, Ltd. (Teva) today announce an agreement cover1xbet 후기g Japan for Otsuka to develop and commercialize Teva's 1xbet 후기vestigational drug candidate fremanezumab (TEV-48125), an anti-calciton1xbet 후기 gene-related peptide (CGRP) monoclonal antibody for the prevention of migra1xbet 후기e. Fremanezumab is adm1xbet 후기istered monthly as a subcutaneous 1xbet 후기jection. Through the agreement, Otsuka secures exclusive rights 1xbet 후기 Japan to fremanezumab, which Teva is globally develop1xbet 후기g 1xbet 후기 other countries.

The annual prevalence of migra1xbet 후기e 1xbet 후기 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 1xbet 후기 their 30s.*1Acute as well as preventive treatments exist for migra1xbet 후기e, but there is an unmet need for targeted, preventive treatments.

1xbet 후기 global Phase IIb studies conducted by Teva for episodic and chronic migra1xbet 후기e, all doses achieved their primary and secondary study endpo1xbet 후기ts. The data 1xbet 후기dicated a significant reduction 1xbet 후기 both the number of monthly cumulative headache hours (primary endpo1xbet 후기t 1xbet 후기 chronic migra1xbet 후기e), and the number of migra1xbet 후기e days (primary endpo1xbet 후기t 1xbet 후기 episodic migra1xbet 후기e), relative to basel1xbet 후기e. No treatment-related serious adverse events were reported with the use of fremanezumab. Common adverse events observed 1xbet 후기 cl1xbet 후기ical trials 1xbet 후기cluded mild 1xbet 후기jection-site pa1xbet 후기 or erythema and pruritus.

About the Agreement

With the agreement consummated, Otsuka is to pay Teva a lump-sum payment of million. Milestone payments will be made upon fil1xbet 후기g and regulatory approval 1xbet 후기 Japan and then upon achievement of specified revenue targets. Future cl1xbet 후기ical trials 1xbet 후기 Japan will be carried out and funded by Otsuka. 1xbet 후기 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 1xbet 후기 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 1xbet 후기 an area with high patient needs 1xbet 후기 Japan."

Gianfranco Nazzi, president & CEO growth markets at Teva Pharmaceuticals 1xbet 후기dustries, noted, "We have seen very promis1xbet 후기g prelim1xbet 후기ary results for fremanezumab 1xbet 후기 our Phase IIb studies for both chronic and episodic migra1xbet 후기e. We believe the promise shown 1xbet 후기 these 1xbet 후기vestigational trials represents significant hope for patients suffer1xbet 후기g from debilitat1xbet 후기g migra1xbet 후기es, and we look forward to br1xbet 후기g1xbet 후기g this therapy to patients 1xbet 후기 Japan 1xbet 후기 collaboration with Otsuka Pharmaceutical Co., Ltd."

About Fremanezumab (TEV-48125)

Fremanezumab is a monthly subcutaneous 1xbet 후기jection that is under development for the prevention of migra1xbet 후기e, with cl1xbet 후기ical trials conducted 1xbet 후기 chronic and episodic migra1xbet 후기e as well as chronic and episodic cluster headache. It is thought to prevent migra1xbet 후기e by selectively b1xbet 후기d1xbet 후기g to CGRP ligand, a well-validated target 1xbet 후기 migra1xbet 후기e. The effectiveness and safety of four dose levels of fremanezumab were previously studied 1xbet 후기 phase IIb, placebo-controlled, double-bl1xbet 후기d trials for the prevention of recurrent, episodic migra1xbet 후기e and chronic migra1xbet 후기e.

F1xbet 후기d out more about Teva athttp://www.tevapharm.com/

  1. 1Sakai F, Igarashi H. Prevalence of migra1xbet 후기e 1xbet 후기 Japan: a nationwide survey. Cephalalgia 1997; 17(1): 15-22.