Moscow. (Dec. 19, 2017) — Amgen (NASDAQ: AMGN) and Pharmstandard announced that the parties have entered into an agreement for the manufacture and commercialization of blinatumomab in Russia.
Under this agreement, Amgen will remain the marketing authorization holder while Pharmstandard will promote blinatumomab in the territory of the Russian Federation. The agreement contemplates that Amgen will perform a transfer of technology for both fill-finish and packaging to Pharmstandard for the local manufacture of blinatumomab.
“We are very excited about our relationship with Pharmstandard in Russia. This collaboration shows our desire to continue to bring Amgen’s innovative medicines to patients in Russia with unmet medical need, now and in the future. We are very pleased that blinatumomab will be the first locally produced Amgen product and that it offers another treatment option to patients with relapsed or refractory acute lymphoblastic leukemia, who have a poor prognosis,” said Oleg Paroshin, Country Director at Amgen Russia.
“This is our first joint project with Amgen, the world`s leader in biotechnology and drug development. As a result of implementation of the project the Russian patients, adults and children, with relapsed or refractory acute lymphoblastic leukemia, will receive access to treatment by the innovative biotechnology product blinatumomab, produced for the first time in the Russian Federation. Local manufacturing of medicines for the treatment of oncology diseases is one of the priorities of Pharmstandard. The manufacturing part of the agreement will be realized at Pharmstandard-UfaVITA JSC, which has all necessary state-of–the–art technological capabilities. We are looking forward to a fruitful partnership with Amgen and development collaboration that meets priorities of the Russian healthcare system and patients’ needs,” stated Grigory Potapov, Chief Executive Officer of Pharmstandard JSC.
Blinatumomab is an innovative immunotherapy for patients with relapsed/refractory (R/R) Ph-negative B-cell precursor ALL. It is the first bispecific antibody construct from Amgen's BiTE® platform, which helps the body’s immune system target cancer cells and represents an entirely new research area in oncology. BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
Amgen is committed to discovering the potential of biology for patients suffering from serious illnesses by developing, perfecting, manufacturing and implementing innovative human therapeutics. This approach is built on using advanced human genetics to unravel the complexities of diseases and understand the fundamentals of human biology.
Amgen focuses on areas of unmet medical need and applies its expertise to improve health outcomes and dramatically improve people's lives A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies. Millions of patients around the world use Amgen medicines. At the moment Amgen is developing a number of drug products with breakthrough potential.
Pharmstandard is a leading Russian pharmaceutical company which develops and manufactures high-quality, affordable and innovative pharmaceutical products to satisfy the needs of patients and the Russian healthcare system. Pharmstandard manufactures more than 250 medicines, more than 120 out of which are included in the List of Vital and Essential Drugs. The pharmaceutical portfolio of the company includes pharmaceutical products for the treatment of cardiovascular diseases, diabetes mellitus, growth hormone deficiency, gastroenterological and infectious diseases, neurological disorders, metabolic disorders, oncology, and a variety of other diseases.
The manufacturing capabilities of Pharmstandard are represented by six manufacturing plants and located across the Russian Federation. Pharmstandard’s state-of-the-art manufacturing facilities correspond to GMP standards and are certified by Russian and EU regulatory bodies.
Under partnership agreements with international pharmaceutical companies, Pharmstandard has localized and manufactured high quality innovative pharmaceutical products.
Pharmstandard is a leading Russian company and one of the biggest distributors of pharmaceutical products in Russia. Also, the company supplies its products to 18 countries around the world.
Elena Shishkina, Access Manager
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