Takeda Submits a New Drug Application for Rasagiline Mesylate for the Treatment of Parkinson’s Disease in Japan

Osaka, Japan, June 29, 2017 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for rasagiline mesylate (generic name, development code: TVP-1012) for the treatment of Parkinson’s disease.

Developed by Teva Pharmaceutical Industries Ltd. (“Teva”), rasagiline mesylate is approved in 55 countries in Europe, the US, and other regions for the treatment of Parkinson’s disease. Teva and Takeda signed an agreement as of the end of March 2014, granting Takeda a right for commercialization and clinical development of rasagiline mesylate in Japan.

The NDA was filed based mainly on the result of the Phase 2/3 clinical trial (Study CCT-002) and the Phase 3 clinical trial (Study CCT-001), conducted in Japan. Study CCT-002, conducted in patients with Parkinson’s disease under the treatment with levodopa, and Study CCT-001, conducted in patients with early stage Parkinson’s disease demonstrated efficacy of the drug without major safety concerns.

“Although medications have greatly contributed to improvement of Parkinson’s disease, the levels of treatment satisfaction are far from satisfactory,” said Toshiro Heya, head of Takeda Development Center Japan. “Therefore, new treatment options are eagerly awaited by patients and healthcare professionals. I am grateful to patients and physicians for their cooperation in developing the drug, as well as looking forward to the day when the drug will be delivered to patients in Japan, which has given sufficient evidence and contributed to the treatment of patients with Parkinson’s disease in 55 countries in the world.”

About Rasagiline Mesylate 
Rasagiline mesylate is an anti-parkinsonian drug with potent, selective irreversible monoamine oxidase type-B (MAO-B) inhibitor activity. By irreversibly binding to MAO-B, it prevents the breakdown of dopamine in the brain, increasing the levels of dopamine within the synaptic cleft, thus providing beneficial effects on Parkinson’s disease (PD) symptoms.

Currently, rasagiline mesylate is approved in 55 countries including the US, Canada, Israel, Mexico, and European countries. Both monotherapy and combination therapy with levodopa are approved as treatment of Parkinson’s disease overseas. Rasagiline mesylate can be used in combination with dopamine agonist, without levodopa, in the US. Worldwide sales in 2016 were USD 410 million (Teva’s financial report). For details of approved labeling in the US and EU, please access the URL below:
http://www.azilect.com/Content/pdf/azi-40850-azilect-electronic-pi.pdf  (US)
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000574/WC500030048.pdf  (EU)

About Parkinson’s Disease
Parkinson's disease is a neurodegenerative disease associated with aging. General symptoms include tremor, akinesia/bradykinesia, rigidity, postural instability, and autonomic nervous system symptoms. The number of patients given a diagnosis of Parkinson’s disease is about 0.163 million in Japan (based on the MHLW Patient Survey 2014). The disease typically develops among those who are over 60 years of age.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited 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 central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Disclaimer
The drug information contained herein is intended to disclose Takeda's corporate information. Nothing contained herein should be considered a solicitation, promotion or indication for any prescription drug including the ones under development.

Contact:
Tsuyoshi Tada
+81 (0) 3-3278-2417
tsuyoshi.tada@takeda.com

###