Termination of license and development agreement for “OBLEAN^® TABLETS 120MG” for treatment of obesity

TERMINATION OF LICENSE AND DEVELOPMENT AGREEMENT FOR “OBLEAN® TABLETS 120MG”
FOR TREATMENT OF OBESITY

Takeda Pharmaceutical to return the rights to Norgine B.V.  

Amsterdam, The Netherlands, 13 July, 2018 and Osaka, Japan – 03:00 AM, Central European Time (CET) / 10:00 AM Japan Standard Time (JST) – Norgine B.V. (Headquarters: Amsterdam, The Netherlands, “Norgine”) and Takeda Pharmaceutical Company Limited (TSE: 4502) (Headquarters: Chuo-ku, Osaka, “Takeda”)announced today that they have agreed to terminate the license and development agreement (“the Agreement”) for the development, manufacture and sale in Japan of OBLEAN^® Tablets 120mg (generic name: cetilistat), a drug for the treatment of obesity, as of 13 October, 2018.

“We appreciate the effort that Takeda made in gaining approval for OBLEAN^® in Japan” said Peter Stein, CEO at Norgine. “We are assessing all options for the future of OBLEAN^® in Japan.”

“I would like to express my appreciation to patients and healthcare providers who made efforts for us to receive the Japanese New Drug Application Approval” said Masato Iwasaki, Ph.D., president of the Japan Pharma Business Unit and director of Takeda,” Takeda will continue to contribute to patients in Japan with its existing range of drugs for lifestyle-related diseases.”

OBLEAN^® is a lipase inhibitor created by Alizyme Therapeutics Limited (“Alizyme”) in the UK. Norgine acquired all rights relating to OBLEAN^® from Alizyme in October 2009. Takeda acquired exclusive rights for the development, manufacture and sale of OBLEAN^® in Japan in August 2003, and obtained a New Drug Application Approval for OBLEAN^® from the Ministry of Health, Labor and Welfare in September 2013. The General Assembly of the Central Social Insurance Medical Council elected not to set an NHI drug price listing in November of 2013.

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net product sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care.

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.

 For more information, please visit www.norgine.com /BD@norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.