New migraine drug! Teva/Otsuka Japan submits Ajovy listing application, Teva/Takeda Japan joint venture sells generic drug assets!

03, 2020 // Teva Pharma and Otsuka Pharma have jointly announced that they have submitted a listing application for Ajovy (fremanezumab) to the Japan Drug and Medical Devices Administration (PMDA) for preventive treatment for migraines.
as part of a May 2017 license agreement on Ajovy's development and sale in Japan, Otsuka Pharmaceuticals is developing Ajovy in the Japanese market.
earlier this year, the two sides published the results of two key clinical studies in Japan on Ajovy's treatment of onset migraines (EM) and chronic migraines (CM).
in both trials, Ajovy showed clinical and statistically significant improvements in primary endpoints compared to placebos.
, Ajovy also had a statistically significant improvement in all secondary endpoints compared to placebos.
safety, Ajovy has good tolerance and similar rates of adverse events compared to placebos.
Ajovy is the first and only long-acting anti-CGRP subcutaneous injection approved by the United States and the European Union for preventive treatment of migraines and offers monthly and quarterly (three-month) options. "This is an exciting milestone that will deliver on our global mission to improve patients' lives by advancing potential new treatments," said Gianfranco Nazzi, executive vice president of
Teva International Markets.
, driven by the desire to deliver high-value products to our patients, we are pleased to be one step closer to offering this treatment option to Migraine sufferers in Japan.
" on the same day, Teva unveiled a new strategic focus for the Japanese market: a joint venture (BV) with Takeda Pharmaceuticals in Japan, which will launch a new strategy for its local commercial operations.
in the nearly five years since its inception, bv's new strategy will focus on commercialselection of complex generics, specialty assets and other pipeline opportunities, following an in-depth review of the market.
the shift will include divesting most of BV's non-differentiated generic portfolio and operating assets from Nichi-Iko Pharmaceutical Co., Ltd., a Japanese drugmaker.
expectthes to close the deal by early 2021.
BV will retain approximately 20 generic soruas and some pipeline assets, as well as its powerful licensed generics, limited liability partnerships and specialty portfolio. "The joint venture between Teva and Takeda is committed to meeting the broad needs of patients and healthcare professionals in Japan," said Gianfranco Nazzi, Executive Vice President,
Tiwa International Markets.
our new strategy will enable all parties to leverage their core strengths and ultimately better serve Japanese patients.
for Teva, based on the company's strategic objectives, the new model provides an opportunity to continue to place patients and healthcare professionals at the center of our strategy by focusing our business in Japan on a select portfolio of generics and specialty asset pipelines.
" () Original origin: Teva Announcs New Drug Application In Japan for AJOVY ® (fremanezumab) Injection.