The first innovative Russian drug in the 21 century was registered in Russia for treatment of HIV infection
Moscow, June 24, 2017 — ELPIDA® (elsulfavirin), a new generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and the first original Russian drug in the 21st century for the treatment of HIV infection, was registered in Russia (Registration Certificate No. LP-004360 of June 30, 2017). The drug was developed by Viriom, a company of ChemRar High-Tech Center, in partnership with F. Hoffmann-La Roche (Switzerland) and with the support of the Russian Ministry of Industry and Trade provided within the Federal Targeted Program “Development of Pharmaceutical and Medical Industry of the Russian Federation up to 2020 and Beyond”. The ELPIDA® development project was approved by the Russian Presidential Commission for Modernization and Technological Development of Russia’s Economy.
A multicenter comparative trial of ELPIDA® conducted in 12 clinical centers and 10 regions of Russia demonstrated high virological and immunological efficacy of the drug that does not depend on the baseline viral load; a high level of drug safety compared to other NNRTIs; and a high genetic barrier for the development of resistance. The obtained data allowed the researchers to recommend ELPIDA® as a first-line treatment for HIV infection in the combination antiretroviral therapy. The results of the drug development were presented at leading Russian and international conferences in 2013–2017.
The full production cycle of the drug, including the pharmaceutical substance, is implemented at CDRI of ChemRar Group.
Irina Tyrnova, the General Director of Viriom, says: “ELPIDA® registration is an event of special importance not only for our company but for the entire pharmaceutical industry in Russia and the CIS. This is the first innovative product in many years in the field of HIV with a full development and production cycle in Russia, developed with state support. The introduction of ELPIDA® into clinical practice as a first-line treatment for HIV infection will significantly increase the safety standards, improve patient compliance with the treatment and ultimately be more effective in the treatment of the dangerous infection. Further development of an innovative HIV portfolio includes the development of a fixed-dose combination of elsulfavirine with nucleoside reverse transcriptase inhibitors and long-acting (up to 3 months) injectable formulations for the HIV treatment and prevention”.
Viriom is a company of ChemRar Group involved in the development of innovative drugs for HIV, hepatitis C and influenza. Viriom, oriented toward top world standards, aimed at an improvement of treatment outcomes and patients’ quality of life, improved access to treatment for all patients who need it, reduction of the burden and full treatment of socially significant infections. www.viriom.ru