TOKYO, Japan & JERUSALEM, Israel I May 15, 2017 I Otsuka Pharmaceutical Co., Ltd (Otsuka) and Teva Pharmaceutical Industries, Ltd. (Teva) 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.
About the Agreement
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 & CEO growth markets at Teva Pharmaceutical 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., Ltd.”
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.
About Otsuka
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 Otsuka Holdings Co., Ltd., headquartered in Tokyo, Japan, with 2016 consolidated sales of approximately $11 billion.
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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva’s net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.
1 Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 1997; 17(1): 15-22.
SOURCE: Otsuka Pharmaceutical Co
Post Views: 27
TOKYO, Japan & JERUSALEM, Israel I May 15, 2017 I Otsuka Pharmaceutical Co., Ltd (Otsuka) and Teva Pharmaceutical Industries, Ltd. (Teva) 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.
About the Agreement
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 & CEO growth markets at Teva Pharmaceutical 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., Ltd.”
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.
About Otsuka
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 Otsuka Holdings Co., Ltd., headquartered in Tokyo, Japan, with 2016 consolidated sales of approximately $11 billion.
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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva’s net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.
1 Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 1997; 17(1): 15-22.
SOURCE: Otsuka Pharmaceutical Co
Post Views: 27
