The Project is implemented in terms of strategic partnerships of companies for transfer of pharmaceutical production technologies
Moscow, November 09, 2020 — Akrikhin, Russian leading pharmaceutical manufacturer, and MSD, an International pharmaceutical company, announced local manufacturing of drugs, Grazoprevir/Elbasvir for treatment of chronic hepatitis C (CHC) and Doravirine/Lamivudine/Tenofovir for treatment of HIV-infection.
Strategic partnership of companies on transfer of technologies for manufacture of innovative medication has been implemented since 2012; and the parties have achieved significant success in this project.
Localization is implemented at the production facility of Akrikhin JSC in the Moscow Region (Staraya Kupavna) in full compliance with the GMP standards.
The current stage of project of local manufacturing of Grazoprevir/Elbasvir drug for treatment of chronic hepatitis C (CHC) assumes commercial output. By the end of 2020 several batches of Grazoprevir/Elbasvir drug in volume of 6 thousand packs will have been produced.
Earlier, in 2020 Companies have concluded agreement on local manufacturing of HIV drug Doravirine/Lamivudine/Tenofovir. Partners have successfully completed preparatory stage and commenced transfer of secondary package and release quality control technologies for further manufacture of fixed drug combination.
Use of Akrikhin JSC production capacities will allow for better availability of innovative drugs for treatment of VHC and HIV-infection.
We proactively participate in Import Substitution Programme and development of manufacture of efficient and, at the same time, available medical drugs. Example of this is local manufacturing of innovative drugs for treatment of viral hepatitis C and HIV-infection on the Akrikhin’s industrial site. In course of our long-term cooperation with MSD, one of the global leaders in the pharmacy industry, we implement joint investments in development of plant in Staraya Kupavna, i.e. create new jobs, our employees adopt global experience in manufacture of innovative products from MSD and apply it for further developments,
– said to Denis Chetverikov, President of Akrikhin.
Innovative drugs help to cure CHS and may ensure comfortable and efficient admission of anti-retro-viral therapy (ARVT) in HIV-positive patients. Transfer of technologies for manufacture of innovative drugs designed for reducing burden of socially-significant diseases is one of key elements of MSD strategy in Russia, and in this we proactively cooperate with Russian manufacturers, — declared Marwan Akar, General Director of MSD in Russia and EAEU. — Of all sales in Russia – over 60% is a share of drugs that are either manufactured locally already or undergo localization stage. Local manufacturing of Grazoprevir/Elbasvir and Doravirine/Lamivudine/Tenofovir on plant of our partner, Akrikhin, — is an important step on the road to better availability of highly effective therapy for Russian patients, as well as to solving tasks of the Russian health care on increase of duration and quality of life of people suffering from socially-significant diseases.
In Russia, according to experts’ estimated data, number of patients suffering from CHC may reach almost 5 mln people. Grazoprevir/Elbasvir is a drug of anti-viral action for treatment of chronic hepatitis C (CHC). The Drug has been registered in Russia in October 2018 for treatment of adult patients with chronic hepatitis C of 1а, 1b and 4 genotypes, as well as genotype 3 in combination with Sofosbuvir. The Drug is included in the list of Vital and Essential Drugs (VED).
Currently in Russia there is over 1 mln people living with HIV1. Doravirine is the drug for treatment of HIV-1 infection in adults within combined anti-viral therapy. Doravirine belongs to class of Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) of new generation with dosage regimen 1 time per day regardless of food intake, is also produced in the form of fixed combination with Lamivudine and Tenofovir. The drug has been registered in Russia in June 2019; fixed combination – in November 2019.
Joint project of MSD and Akrikhin JSC on local manufacturing has been initiated in 2012. Within 8 years of joint work the manufacture of 7 MSD drugs for treatment of cardio-vascular, allergic and respiratory diseases, diabetics, mycotic infections and chronic hepatitis C has been launched. In frame of the project the technology processes (“know-hows”) have been transferred, production lines and laboratories have been refitted, and the personnel have been additionally trained. Within the period from 2014 to 2018 project of organization of production of finished dosage form for four localized drugs has been successfully implemented.
According to the World Health Organization as of the end of 2019, there were 38 million people with HIV-infection across the globe. As of the end of 2019, 25.4 million people received anti-retro-viral therapy (ARVT). Within the from 2000 to 2019 number of new cases of HIV-infection has dropped by 39%, and mortality rate due to reasons associated with HIV has decreased by 51%; whereby, 15.3 million human lives were saved due to the ART.
Currently in Russia there is over 1 mln people living with HIV1. Nowadays, HIV-infection has spread far beyond vulnerable groups of population and is actively spreading in the society. Most of patients first diagnosed in 2020 were infected as result of heterosexual contacts (63.2%). In the first half of 2020 557,556 patients received anti-retro-viral therapy in Russia. In 2020, in the Russian Federation the treatment covered 50.3% of those living with HIV-infection diagnosis, and 73.9% of those at regular medical check-up.
About chronic hepatitis C (CHC)
According to the World Health Organization, nowadays ca. 71 mln people suffer CHC making it one of most widespread diseases in the world. Every year, almost 1.75 mln people get infected with it. Almost 2.7 mln patients died within the period from 2000 to 2016 due to hepatic cirrhosis and hepatocellular carcinoma as most dangerous complications of CHC. Modern studies conducted in Russia also detected wide spread of the disease. According to experts, real number of patients may reach almost 5 mln people putting Russia on the fifth place in world by number of patients with hepatitis C.
Prior to prescribing any drug mentioned herein, please read through entire administration manual provided by the manufacturing company.
MSD does not recommend using the company drugs by methods different from those described in the administration manual.
1As of 30 June 2020 the total number of registered cases of HIV-infection amounted to 1,465,102 people (according to preliminary data), http://www.hivrussia.info/wp-content/uploads/2020/07/Spravka-VICH-v-Rossii-1-polugodie-2020.pdf.