Otsuka Pharmaceutical Co. Ltd. (Otsuka) and R-Pharm Group signed a licensing agreement to manufacture and market Deltyba™ (Delamanid), a drug for the treatment of pulmonary multidrug-resistant tuberculosis, in Russia and CIS.
Delamanid was developed by Otsuka and is currently registered under Deltyba™ trademark. Under the terms of agreement, OtsukaNovelProductsGmbH (ONPG), a subsidiary, granted R-Pharm a license to register Deltyba in the Russian Federation and market the product after the approval by the regulatory authority. The two parties also discussed the development of a technology transfer plan to facilitate the manufacturing of Deltyba™. After preparing the registration dossier of the medicinal product in the Russian Federation, R-Pharm can expand its registration and marketing activities to CIS.
Vasily Ignatyev, the CEO of R-Pharm said, “Over the past years, Russia experienced a decline in registered incidence of this disease, but we are increasingly confronted with a new, drug-resistant form of tuberculosis. The cooperation with Otsuka, which will include the localization of Deltyba manufacturing on the facilities of R-Pharm, will help to address this problem.”