JERUSALEM & TOKYO--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Takeda Pharmaceutical Company Limited (Takeda) have signed an agreement allowing Takeda to commercialize Teva’s innovative treatment for Parkinson’s disease, rasagiline* (active ingredient) in Japan.
Developed by Teva, rasagiline tablets are approved in over 40 countries for the treatment of Parkinson’s disease. Teva developed this product and received its first approval in 2005 in Israel and Europe, and is currently working towards the acquisition of marketing approval of this product in Japan. Under the terms of the agreement, Takeda will develop rasagiline tablets for the Japanese market and submit a New Drug Application for registration of the product in Japan. The financial details of the agreement are confidential.
Rasagiline is a monoamine oxidase B (MAO-B) inhibitor which is presumed to act by increasing available synaptic dopamine in the brain which may improve the motor symptoms characteristic of Parkinson’s disease.
Teva and Takeda announced an agreement in December 2013, to develop glatiramer acetate* (active ingredient) for the treatment of multiple sclerosis. Recognizing a high unmet need in the treatment options for Parkinson’s disease in Japan, the two companies have now entered into a further agreement in the CNS category.
“This agreement represents Teva’s continued commitment to introducing our innovative medicines to patients in Japan,” stated Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer. “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.”
“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,” said Nancy Joseph-Ridge, M.D., General Manager of Takeda’s Pharmaceutical Development Division. “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.”
* While Rasagiline and Glatiramer Acetate are marketed globally as Azilect® and Copaxone® respectively, their product names have not yet been approved in Japan.
** Parkinson’s disease treatment guideline 2011, supervised by Japan Society of Neurology
About Rasagiline
Rasagiline is indicated for the treatment of the signs and symptoms of Parkinson's disease (PD) both as initial therapy alone and to be added to levodopa later in the disease.
Side effects seen with rasagiline alone are flu syndrome, joint pain, depression, and indigestion; and when taken with levodopa are uncontrolled movements (dyskinesia), accidental injury, weight loss, low blood pressure when standing, vomiting, anorexia, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.
See additional important information at www.azilect.com/Resources/pdf/PrescribingInformation.pdf
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com
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