MSD, an innovative global pharmaceutical company, and AKRIKHIN, a leading Russian pharmaceutical manufacturer, announced the successful launch of local production of a 100 mg finished dosage form of sitagliptin, an oral anti-hyperglycemic drug for type 2 diabetes. The project was implemented as a part of the strategic partnership between the companies for the transfer of pharmaceutical manufacturing technology to Russia that began in 2012.
Sitagliptin is manufactured at AKRIHIN’s production facility in the Moscow region (Staraya Kupavna) in full compliance with GMP standards. The manufacturing process includes incoming quality control, preparation of the active pharmaceutical ingredient and excipients, preparation of the finished dosage form, packaging and release quality control.
To date, 75,000 packages of sitagliptin have been produced and released. The Russian-made medicine will become available in Russian pharmacies in Q2 2018. The batches of sitagliptin that are currently in circulation have been packaged at AKRIHIN’s plant. By the end of 2018, the company plans to manufacture up to 200,000 packages of sitagliptin, starting with the stage of finished dosage form preparation.
MARWAN AKAR, General Director, MSD, Russia and Eurasian Economic Union:
Localizing production of medicines for the treatment of socially significant diseases is one of the key pillars of MSD’s strategy in Russia. Sitagliptin has become the second MSD medicine of which production has been localized as part of our long-term partnership with AKRIKHIN, beginning with the dosage form preparation stage. This is an important step towards improving access to highly effective and safe therapy for Russian patients in line with state priorities in healthcare and development of the pharmaceutical industry.
Denis Chetverikov, President, AKRIKHIN:
Localizing pharmaceutical production in Russia is one of the most effective ways of quickly populating the domestic market with modern medicines. AKRIKHIN and MSD’s strategic partnership encourages the development of the Russian pharmaceutical industry, the application of new technologies and the production of more effective and at the same time more affordable medicines. I am confident that such close cooperation will significantly expand Russian consumers’ access to the most in-demand medicines produced in accordance with the highest quality standards at AKRIKHIN’s production facility.
According to the International Diabetes Federation (IDF), in Russia there are 9.3 million people with diabetes, while the number of undiagnosed patients with diabetes is approximately 5 million people. Roughly 90% of registered patients in Russia have type 2 diabetes.
Sitagliptin, developed by MSD, is the first DPP-4 inhibitor in its class. In Russia, the medicine has been approved for use in treatment of type 2 diabetes since 2007 and has been included in the List of Vital and Essential Drugs (VED) since 2015.
The joint MSD and AKRIKHIN project to localize production was initiated in 2012. Over five years of joint work, production of seven key MSD medicines has been established, for the treatment of cardiovascular, allergic and respiratory diseases, diabetes and fungal infections. Under the project, technology is transferred, production lines and laboratories are refitted and staff are given additional training. In 2014, a project was launched to set up production of the finished dosage form of four localized products, which is planned for completion before the end of 2018. The total investment by MSD and AKRIKHIN in the project will be 330 million rubles.
For more than a century, MSD has been one of the leading global healthcare companies. We create, develop, produce and sell innovative prescription medicines, including biologics and vaccines, that help maintain and improve people’s health. MSD’s portfolio includes products to treat and prevent cancer, diabetes, hepatitis C, HIV and other infectious diseases, autoimmune inflammatory diseases, respiratory diseases, circulatory diseases and more. We also conduct and support programs and partner projects designed to boost the accessibility of medical care. MSD has been operating in Russia since 1991, focusing on ensuring access to innovative medicines and vaccines, partnership with local manufacturers and leading medical institutions, as well as supporting medical education. We apply our extensive global experience to make a contribution to the development of healthcare and the pharmaceutical industry in Russia. More information can be found at www.msd.ru or www.msd.com.
AKRIKHIN is one of the leading Russian pharmaceutical companies, producing effective, affordable and high quality medicines in the most popular therapeutic areas in Russia. The company is in the top five leading local pharmaceutical producers by sales on the Russian market and continues to demonstrate significant growth and development rates. AKRIKHIN’s product portfolio comprises some 200 medicines, more than 100 of which are manufactured at a production facility in the Moscow region. AKRIKHIN’s key therapeutic areas are tuberculosis, diabetes, dermatology, cardiology, neurology, gynecology and more. All products are manufactured in full compliance with GMP standards.
In line with state and industry priorities, AKRIKHIN is actively involved in localization and import substitution of medicines through its own R&D center and also through partnership with international pharmaceutical producers. In 2014 – 2015, as part of its import substitution program, the company released 10 medicines on the market. AKRIKHIN is committed to regularly updating its product portfolio through its own developments and also via effective cooperation with other pharmaceutical companies and leading R&D institutions in Russia and other countries. AKRIKHIN’s production facility is located 20 km from Moscow and includes a facility for the manufacturing of soft and solid dosage forms, annual output of which is more than 80 million packages. In 2010-2016, the company implemented an investment program to modernize production facilities that involved a total investment of more than 35 million euros. AKRIHKIN employs 1,500 staff, 800 of which work at the production facility in Staraya Kupavna in the Moscow region.