Under the terms of the new agreement, Takeda will develop rasagiline tablets for the market in Japan and will be responsible for submitting a New Drug Application for product registration. No financial details of the agreement were disclosed by either company.
Dr. Michael Hayden, Teva’s President of Global R&D and CSO, said, “This agreement represents Teva’s continued commitment to introducing our innovative medicines to patients in Japan. Rasagiline has an established safety and efficacy profile and is currently approved for use in over 40 countries, and will be an important product for Japan, where the number of available treatment options for Parkinson’s disease remains limited.”
Rasagiline is a monoamine oxidase B (MAO-B) inhibitor indicated as treatment for the signs and symptoms of Parkinson’s disease, both as an initial therapy and as adjunct to levodopa later in disease progression. Teva developed rasagiline tablets and received its first regulatory approval in 2005 in Israel and Europe. The drug is currently approved in more than 40 countries. The company is currently working to secure marketing approval for rasagiline in Japan.
Nancy Joseph-Ridge, General Manager of Takeda’s Pharmaceutical Development Division, said, “It is estimated there are about 150,000-180,000 people diagnosed with Parkinson's disease in Japan, many of whom are waiting for a new treatment option. We will continue working on the development in cooperation with Teva so that we can bring this medicine to Japanese patients as quickly as possible.”
Parkinson’s Disease is a progressive disease that afflicts approximately 7 to 10 million people worldwide. The disease affects as many as one million people in the U.S, with about 60,000 new diagnosed cases every year. PD is characterized by primary, secondary, and nonmotor symptoms. Rasagiline is thought to improve motor symptoms of patients with PD by increasing available synaptic dopamine in the brain.