Company Overview
"Hepatera", Ltd is a private biotechnology company, founded in 2011 with the goal to develop and launch into the Russian market innovative products for treatment of liver diseases. Since December 2011 Hepatera has become a resident of Skolkovo Biomed Cluster.
The first product (Myrcludex B) is aimed at treatment of chronic viral hepatitis B and D, and is developed in close cooperation with a German biotech company MYR GmbH.
By the end of 2011, Myrcludex B’s safety was shown in a series of preclinical studies - antiviral activity was assessed in in vitro and in vivo experiments. In an in vivo model with transplanted hepatocytes susceptible to hepatitis B virus, adding Myrcludex B completely prevented development of HBV infection. In early 2012, results from the clinical trial phase Ia showed the safety and good toleration of Myrcludex B in humans. Later in 2012 the Company received the regulator’s approval and started Phase 1b/2a clinical trial in Russia.
Market Opportunity
Chronic viral hepatitis B (CHB) is one of the serious problems that healthcare systems are faced globally. According to the World Health Organization, the prevalence of HBV (hepatitis B) infection in the world is very high: about 2 billion people are carriers of HBV, of which about 400 million are chronically ill (2008 data). Every year about 50 million people get infected with HBV and about 2 million people die from liver diseases caused by the virus: liver cirrhosis and hepatocellular carcinoma, as well as the fast-flowing fulminant hepatitis. Only a relatively small share of patients with liver disease receive appropriate treatment.
About 5% of patients with CHB are co-infected with HDV, which increases the severity of disease and hasten the complications, doubling the 5-years mortality rate. So far there are limited options to treat the HDV co-infection.
According to the global studies in 2009 the market for chronic hepatitis B (HBV) therapy amounted to about $1 billion. Despite significant market growth in the last decade, due to the market launch of nucleosides, the world market remains unsatisfied and has substantial growth potential. Moreover there are no drugs at the market to treat the HDV infection.
According to the available expert estimates, there are 2-8 million HBV carriers in Russia, this number represents the “medium” level of prevalence (2-7%) in the WHO classification.
A gradual decrease in incidence of hepatitis B due to introduction of vaccination is forecasted. But, at the same time, the higher awareness and improvement in the quality of care will cause an increase in the number of patients diagnosed with the disease and requiring treatment, which is expected to provide a continuing high level of demand for the drug.
Product and Technology
Myrcludex B is a novel drug candidate, being a linear 47-amino acid chemically synthesized peptide. So far it is the single representative of a novel class of anti-HBV molecules, called entry inhibitors. The postulated mechanism of antiviral action is the highly specific and highly stable binding to HBV receptors on the surface of hepatocytes, which misdirects HBV to an unproductive pathway and thereby prevents an infection of the cell. This unique mechanism of action offers the possibility to address the two most important medical needs, namely long-term HBV eradication as well as antiviral activity against hepatitis D virus (HDV).
Myrcludex B has proven to be safe and able to completely block the development of virus B infection.
Team
Medical adviser of the project is MD Pavel O. Bogomolov, a hepatologist, head of hepatology department of MONIKI named after M.F.Vladimirov, head of the Moscow regional hepatology center, leading hepatologist of Moscow region. Company’s management is comprised of highly qualified specialists from Maxwell Biotech Group and Russian biotech industry.
Intellectual Property
The company’s assets include an exclusive license for the Myrcludex B purchased from “MYR GmbH”, which covers the territory of Russia and the other members of the Eurasian Patent Convention (Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Moldova, Azerbaijan, and Armenia) and Ukraine.
Contact
Dr. Oksana Markova, Chief executive officer
1 Bolshaya Yakimanka str., Moscow, 119180, Russia
Tel: +7 (495) 411-69-92, Fax: +7 (495) 411-69-93
Email: markova@hepate