R-Pharm Rolls Out Arlansa for Treatment of Chronic Viral Hepatitis C

| By | Clinical Trials, R-Pharm, Technology transfer, Vasily Ignatiev

A new direct acting antiviral drug Arlansa (Narlaprevir) for therapy of VHC was introduced within All-Russian research and practice conference III with international engagement “Socially significant and highly infectious diseases” in Sochi on November 3d, 2016. This is the first registered pelleted domestic NS3 serine protease inhibitor administered in combination with other antiviral drugs.

On the first day of the conference, November 1st, there took place a research and practice forum named “Domestic VHC protease inhibitor: from development to clinical practice” where final clinical findings for Arlansa were introduced as well as prospects of its administration as part of chronic VHC interferon-free regiment.

The following persons took part in the conference: I.V. Shestakova, the chief independent infectiologist of Ministry of Healthcare of the Russian Federation; V.A. Isakov, the head of gastroenterology and hepatology department of nutrition research institute of RAS; K.V. Zhdanov, correspondent member of RAS and the chief infectiologist of Ministry of Defense of the Russian Federation; I.G. Nikitin, the head of hospital therapy department of Pirogov Russian National Research Medical University; O.O. Znoyko, Professor of infectious disease department of A.I. Evdokimov Moscow State University of Medicine and Dentistry; E.A. Strebkova, Assistant Professor and the head of department of the clinic for infectious diseases of Samara State Medical University.

Summarizing the results of the forum the experts emphasized the importance of introducing accessible treatment regiments for patients with noncomplicated chronic Hepatitis C in order to prevent the development of heavy liver conditions and to decrease social and economic damage caused by the disease.

Narlaprevir successfully passed extensive pre-clinical and clinical trials in Schering-Plough Research Institute (USA) and in a variety of clinical centers of Europe, USA and Russia. The drug was developed in collaboration with the Texas Liver Institute (USA), the global leading hepatology center. In 2014-2016 a large scale phase III PIONEER trial was held. It was named “Evaluation of safety and efficiency of Narlaprevir in patients with chronic VHC (genotype 1) who were not treated with pegylated interferon and Ribavirin before or whose earlier treatment with those drugs was inefficient”. The largest Russian centers specialized in the treatment of viral hepatitis took part in the studies. The research made it possible to get all the required data on the use of Narlaprevir in the Russian population of patients with prevailing VHC infection genotype 1b.

Based on clinical findings R-Pharm obtained a registration certificate for Arlansa (Narlaprevir) ЛП-003622 dd 12.05.2016 issued by Ministry of Healthcare of the Russian Federation.
R-Pharm continues to make investments in development of the scientific basis of the drug: it holds supportive studies on drug interactions, including antiretroviral agents, as well as studies on pharmacokinetics in patients with compensated hepatic disorders. It invests in studies of the drug efficiency and safety in interferon-free combinations with other direct acting antiviral drugs.

Director General of R-Pharm group Vasily Ignatiev emphasized that over 700 mln rubles were invested in the development and clinical research of Narlaprevir (completed studies and current research).

The development of the drug was supported by the Federal target program “Development of pharm and medical industry of the Russian Federation until 2020 and beyond”. In 2011 Ministry of Industry and Trade and R-Pharm concluded a state contract on foreign development transfer and production of the innovative drug in Russia. R-Pharm transfers production of the drug to its pharm complex in Yaroslavl region within this contract.
Arlansa (Narlaprevir) will be available in the pharmacies of Russia already in the fourth quarter of 2016. Besides Russia, R-Pharm is planning to commercialize this medication in a number of other countries where chronic VHC genotype 1b prevails, specifically in Turkey.

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