Pfizer and Pharmstandard have signed an agreement on contract manufacturing in the territory of the Russian Federation (at Pharmstandard-UfaVITA plant, the Republic of Bashkortostan) of innovative medicinal products for the treatment of breast cancer, lung cancer, kidney cancer, and chronic myeloid leukemia. Pharmstandard-UfaVITA will provide the partner with product manufacturing services. The first commercial batches are expected to be released in 2024.
The partners are currently embarking on a step-by-step technology transfer implementation, including the equipment purchase required for Pfizer product manufacturing, the manufacturing site reconstruction, the technology and analytical method transfer, the commercial manufacturing launch. Within the frames of the project, it is planned to localize the full-cycle manufacturing of 4 innovative medicinal products in 8 strengths. The partners expect to manufacture approximately 2 million tablets and capsules per year.
Pfizer medicinal products, to be manufactured at Pharmstandard site, are in high demand on the Russian market, given the priority of tasks to fight widespread oncology diseases in the country, for which they are indicated – breast cancer, lung cancer, kidney cancer, and chronic myeloid leukemia.
“Pfizer’s goal is to deliver breakthroughs that change patients’ lives. We are driven by aspirations to provide patients with access to quality and advanced treatment. Pfizer’s investment strategy in Russia is designed to foster innovations and enhance medical care to extend for Russians life expectancy and raise their quality of life. We are confident that by partnering with Pharmstandard, we will be able to meet the demand of Russian patients for medicinal products for oncology therapy, which remains one of the most pressing healthcare challenges in Russia”, commented Eric Patrouillard, General Manager, Pfizer, Russia and Belarus.
Choice making about products to be localized is primarily contingent on the essential needs of oncology patients in Russia.
Indeed, breast cancer (BC) is one of the most common malignancy and cause of cancer death in women 1, especially in the metastatic form of the disease. Lung cancer also belongs to malignant neoplasms with a high mortality rate: often, the disease is diagnosed in the later stages 3–4 2. Kidney cancer stands out at a high rate of annual increase in incidence 3. The prevalence of hematologic malignancies is also growing. Modern standards for the treatment of these dangerous diseases include innovative targeted medicines 3.
All four medicinal products of the localization project are included in the List of Vital and Essential Drugs (VED).
“The manufacturing of medicinal products for the treatment of oncology patients remains one of the strategic areas of Pharmstandard development. In recent years, the list of curable cancers has expanded significantly. Today, there are advanced and effective methods in cancer diagnosis and therapy, innovative medicines that help patients beat disease and return to a socially active, full-quality life. Together with our partners and the public sector, we are faithfully striving for cancer drug provision. And we are glad to cooperate with Pfizer, which we have been pursuing over the past years. We have extensive expertise in localizing high-tech product manufacturing. And we are confident that the manufacturing of products from Pfizer oncology portfolio at Pharmstandard facilities will give the opportunity for the partner to expand patient access to necessary treatment”, noted Grigory Potapov, CEO of Pharmstandard JSC.
Pfizer: Breakthroughs that Change Patients’ Lives
Through innovation and global resources, Pfizer strives to improve human health and well-being at any stage in life. We aspire to set high quality and safety standards for studies, development, and manufacturing of medicinal products. The company’s product portfolio comprises medicinal products, including vaccines.
Pfizer employees devote their efforts to advance prevention and treatment of today`s most serious diseases in the advanced and developing world daily. Consistent with our commitments as one of the world’s leading biopharmaceutical companies, Pfizer collaborates with healthcare professionals, government agencies and local communities to ensure and expand access to reliable, quality healthcare around the world.
For more than 170 years, Pfizer has worked to make a difference for all who rely on us.
To learn more about Pfizer’s activities, please visit our website www.pfizer.ru
Pharmstandard is one of the leading Russian pharmaceutical manufacturers. For many years, the company has been developing, manufacturing and launching to the Russian market high-quality, modern and affordable medicinal products that meet the needs of patients and the Russian healthcare system. The company manufactures more than 450 medicines, including all dosage forms, strengths, and products intended for export. Over 140 of them are included in the List of Vital and Essential Drugs. The pharmaceutical portfolio of the company comprises products for treatments of cardiovascular diseases, diabetes mellitus, growth hormone deficiency, metabolic and neurological disorders, respiratory, oncology, gastroenterological, contagious diseases and others.
The company’s pharmaceutical manufacturing facilities are located in Kursk, Ufa, Tomsk, and Volginsky settlement (Vladimir Region). The pharmaceutical manufacturing is compliant with the requirements of the Good Manufacturing Practices, which is verified by the GMP compliance certificates.
Pharmstandard is one of the leaders in localizing innovative medicinal products in Russia under partnership agreements with international pharmaceutical companies. The company’s products are supplied throughout the Russian Federation and abroad.
1. Breast cancer. National Medical Research Radiological Center of the Ministry of Health of Russia, FSBI https://nmicr.ru/meditsina/onkologicheskie-zabolevaniya-i-programmy-lecheniya-raka/programma-protiv-raka-verkhnikh-dykhatelnykh-putey-i-grudnoy-kletki/rak-molochnoy-zhelezy/
2. The Minimal Clinical Recommendations of the European Society for Medical Oncology (ESMO). 2010
3. The incidence rate of malignancies by gender and localization. Healthcare in Russia – 2019. Federal State Statistics Service. https://rosstat.gov.ru/bgd/regl/b19_34/Main.htm