myrcludex -b hepatera 公司 背景介绍

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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

Hepatera ” ， Ltd是一家私人生物技术公司，成立于2011年，其目的是研制和发射成治疗肝病的俄罗斯市场的创新产品。自2011年12月Hepatera已成为斯科尔科沃生物医学集群的居民。
第一个产品（ Myrcludex B）的目的是治疗慢性病毒性肝炎B和D ，并开发出符合德国生物技术公司MYR有限公司密切合作。
到2011年底， Myrcludex B的安全性被证明在一系列临床前研究 - 抗病毒活性进行了评估在体外和体内实验。在体内模型移植肝细胞受到乙肝病毒，增加Myrcludex乙完全阻止乙肝病毒感染的发展。在2012年初，从临床试验阶段IA结果显示，人类的安全性和Myrcludex乙良好的耐受性。后来在2012年公司收到监管机构的批准，并开始第一期1b/2a临床试验在俄罗斯。
市场机遇
慢性病毒性乙型肝炎（CHB ）是严重的问题，医疗系统在全球范围内面临之一。据世界卫生组织， HBV （乙肝）病毒感染在世界的患病率非常高：约2十亿人是乙肝病毒携带者，其中约4亿为长期病患者（ 2008年数据） 。每年约有5000万人感染了乙肝病毒和大约2万人肝病病毒造成的死亡：肝硬化和肝癌，以及水流湍急的暴发性肝炎。只是一个相对较小的份额肝病患者得到适当的治疗。
约5％的慢性乙肝患者都同时感染HDV ，从而增加疾病的严重程度和加快并发症，增加一倍的5年死亡率。到目前为止，有选择有限看待HDV合并感染。
根据2009年市场的全球研究慢性乙型肝炎病毒（HBV ）治疗为大约$ 1十亿。尽管有显著的市场增长在过去十年中，由于市场启动核苷，世界市场仍然不满意，并具有庞大的增长潜力。而且没有药物在市场上治疗HDV感染。
根据现有专家估算，目前在俄罗斯2-8亿乙肝病毒携带者，这个数字代表流行的“中等”级别（ 2-7 ％ ）的WHO分类。
由于引入疫苗接种的逐渐减少乙肝的发病率进行了预测。但是，与此同时，较高的知名度和提高护理质量将导致更多的病人与疾病的诊断和治疗需要，预计将提供对药物需求的持续高水平的数量。
产品与技术
Myrcludex B是一个新的候选药物，作为一个线性47 -氨基酸化学合成的肽。到目前为止，它是一个代表性的一类新的抗HBV的分子，称为进入抑制剂。的抗病毒作用的推测机制是高度特异性和高稳定的肝细胞的表面，其引上错误的HBV一种非生产性的途径，从而防止了电池的感染上结合乙肝病毒的受体。这种独特的作用机制提供了可能，以解决两个最重要的医疗需求，即长期乙肝病毒消灭，以及对丁型肝炎病毒（HDV ）的抗病毒活性。
Myrcludex乙已被证明是安全的，并能完全阻止的病毒感染B的发展。
团队
该项目的医学顾问，是医学博士帕维尔· O。博戈莫洛夫，一个肝病，头MONIKI的肝病科MFVladimirov而得名，莫斯科地区肝病中心主任，莫斯科地区的领先肝病。公司管理层由来自麦克斯韦生物科技集团和俄罗斯生物技术行业高级专门人才。
知识产权
该公司的资产包括「马币有限公司“ ，其中涵盖了俄罗斯的领土和欧亚专利公约（白俄罗斯，哈萨克斯坦，吉尔吉斯斯坦，塔吉克斯坦，土库曼斯坦，摩尔多瓦，阿塞拜疆和亚美尼亚的其他成员购买了独家许可的Myrcludex乙）和乌克兰。
联系
奥克萨娜是Markova博士，首席执行官
1的Bolshaya Yakimanka海峡，莫斯科， 119180 ，俄罗斯
电话：+7 （ 495 ） 411-69-92 ，传真：+7 （ 495 ） 411-69-93
电子邮件： [email protected]

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Myrcludex-B，病毒入侵抑制剂，可阻止病毒进入肝细胞，德国海德堡大学奥本博士组研制，目前正在俄罗斯进行IIa临床试验，2013年底揭盲。预计2017年上市。

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