Amgen LLC and Pharmstandard JSC announced the signing of an agreement on technology transfer, manufacturing and commercialization of blinatumomab in the Russian market.
Under this agreement, Amgen will remain the holder of the registration certificate, while Pharmstandard will be responsible for promoting blinatumomab within the Russian Federation. In addition, according to the signed agreement, Amgen will transfer to Pharmstandard the technology for full-cycle manufacturing of blinatumomab and packaging of finished products.
Oleg Paroshin, the General Director of Amgen in Russia, said, “We are enthusiastic about the relationship that we have with Pharmstandard in Russia. This collaboration allows us to demonstrate our commitment to making the innovative medicinal products of Amgen available to Russian patients, whose medical needs in them have not yet been met, and we will continue to do so in the future. We are very pleased that blinatumomab will be the first locally manufactured product of Amgen. This will open a new therapeutic opportunity for the treatment of patients with relapsed and refractory forms of acute lymphoblastic leukemia, for whom the prognosis is unfavorable today.”
Grigory Potapov, the Director General of Pharmstandard JSC, said, “This is our first joint project with Amgen, a global leader in biotech and development of medicinal products. Following the implementation of this project, the Russian patients, including both adults and children with relapsed and refractory forms of acute lymphoblastic leukemia, will be able to receive the treatment with blinatumomab, an innovative biotech drug which is for the first time manufactured in Russia. Localizing the manufacturing of drugs for the treatment of oncological diseases is one of priorities for Pharmstandard. The joint project with Amgen will be implemented at the site of Pharmstandard-Ufavita JSC, as this plant has the required production capacity. We hope for the fruitful collaboration with Amgen and expansion of cooperation in accordance with the priorities of Russian health care system and the interests of patients.”