Takeda LLC (Takeda Russia) and Pharmstandard JSC announced the release of the first batch of brentuximab vedotin, trading as ADCETRIS®, an innovative oncohematological drug for the treatment of patients with Hodgkin’s lymphoma at the plant of Pharmstandard-UfaVITA OJSC (Ufa). Localization of production will increase the availability of the drug for patients in Russia, open up possibilities for export deliveries to the CIS countries, as well as help to reduce cost of the product in the longer term.
“We are committed to provide Russian patients with innovative medicines from the Takeda global portfolio,” says Andrey Potapov, General Director of Takeda Russia, head of the CIS area, - thanks to cooperation between Takeda and Pharmstandard we establish the production of brentuximab vedotin in Russia, and patients with Hodgkin’s lymphoma have a chance to extend their lives.”
“The localization of an innovative drug production is a complex labor-intensive process that requires the well-coordinated work of an international team of specialists. Brentuximab vedotin is a part of Takeda’s global portfolio of innovative medicines and it was crucially important for us that the transfer of the production of the drug be carried out on a production site that meets all the requirements of international and Russian requirements. We approached the choice of a partner for the implementation of this project very carefully and are glad that we chose Pharmstandard,” commented Andrey Obruchnikov, Commercial and Logistics Director, Takeda Russia, Already this year we plan to release several thousands of packages and in a partnership with Pharmstandard we consider the possibility of increasing production next year in order to improve access to innovative treatment for patients in the CIS countries through export supplies.”
“Today one of the focus areas of Pharmstandard is a local manufacturing of innovative drugs for treatment of oncologic and hematologic diseases. That is why cooperation with Takeda is strategically important for us. As a result of this project, patients will get excess to innovative target therapy that is a breakthrough in control of this serious disease, impairing lymphatic system. Preservation of patients’ life and a prospect of rehabilitation are advance objectives of the Russian national policy. I am glad that we make a substantial contribution to oncologic diseases therapy and development of healthcare delivery,” noted Grigory Potapov, General Director of Pharmstandard JSC.
The oncohematological drug brentuksimab vedotin for patients with Hodgkin's lymphoma was registered in Russia in February 2016 and is for use for patients with recurrent / refractory CD30 + Hodgkin's lymphoma and recurrent/refractory systemic anaplastic large cell lymphoma (SACCL)1. The drug is a conjugate of a monoclonal antibody and an antineoplastic agent that acts on tumor cells that have a CD30 marker on the surface, causing a controlled process of their death.
The introduction of this antibody into clinical practice provides patients who have exhausted the resources of classical treatment regimens, the possibility of long-term remission, and gives a chance for a cure.
About Hodgkin’s lymphoma and SACCL
Hodgkin's lymphoma and SACCL are oncohematological diseases affecting the lymphatic system, and in later stages they spread to other systems and organs. In Russia, more than 3,000 new cases of Hodgkin's lymphoma are detected annually. The death rate from this disease is about 10002 people per year, and more than half of the patients are young able-bodied people aged 16 to 35 years3.
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries.
Takeda Pharmaceuticals, LLC located in Moscow, is the Russian marketing and sales organization of Takeda Pharmaceutical Company Limited, Osaka, Japan. Additional information about Takeda Pharmaceutical Company Limited is available on its website https://www.takeda.com/, about Takeda Pharmaceuticals, LLC on https://www.takeda.com/ru-ru/
Pharmstandard is a leading pharmaceutical company in Russia, included in the List of strategic country enterprises. The Company’s total manufacturing capacity exceeds 1.7 bln. packs per year, 700 thousand liters of pharmaceutical substances. Pharmstandard produces more than 330 pharmaceutical products, including medications to treat cardiovascular diseases, diabetes mellitus, growth hormone deficiency, gastroenterological, neurological, infectious diseases, and metabolic disorders, oncologic and other diseases. More than 140 pharmaceutical products (considering all dosage forms and dosages) included in the “Vital and Essential Drugs List”. Pharmstandard is one of Russian leading pharmaceutical companies in local manufacturing of innovative medical products of leading global producers.
Manufacturing sites of the Company meet the requirements of Good Manufacturing Practice and are completed with state-of-the-art manufacturing and laboratory equipment. The Company supplies its products throughout Russia and abroad.
 Instruction leaflet for medical use of the medical product ADCETRIS®. Product license ?? 003476
²Malignant neoplasms in Russia in 2016 (incidence and mortality). Under the editorship of A.D. Kaprin, V.V. Starinsky, G.V. Petrova - M.: MSROI n.a P.A. Herzen FSBI Branch “NMRRC” of Ministry of Health of the Russian Federation, 2018. - 250 p.
³Russian Clinical Guidelines in Diagnoses and Management of lymphoproliferative Diseases. Under the editorship of prof. I.V. Poddubnaya, prof. V.G. Savchenko - ?: OOO «Buky Vedy» Print shop. – 2016. – 324 p.