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Hepatera Ltd and its development partner MYR GmbH announced today the results of clinical trials investigating Myrcludex B in patients with chronic hepatitis B (HBV) and delta (HDV). The results suggest that Myrcludex B may become an option for treating hepatitis delta.

Hepatera Ltd and its development partner MYR GmbH announced today the results of clinical trials investigating Myrcludex B in patients with chronic hepatitis B (HBV) and delta (HDV). The results suggest that Myrcludex B may become an option for treating hepatitis delta. With details to be presented at the AASLD meeting in Boston in November 2014, the trials also indicate positive results for the treatment of HBV infection.

A Phase 2a trial investigating effects of several Myrcludex B doses in 40 patients with chronic HBV infection showed that the drug was very well tolerated. A dose-dependent effect on HBV DNA was observed: >1 log10 HBV DNA decline at week 12 occurred in 6/8 (75%) patients receiving 10mg Myrcludex B while this occurred less often in the remaining dose groups (7/40; 17%). The HBV DNA response was maintained in 10mg patients through week 24.

In a Phase 2a trial in chronic HDV infection with 24 patients, Myrcludex B was investigated as monotherapy vs combination with pegylated interferon alpha for 24 weeks; a control arm received pegylated interferon alpha alone. Myrcludex B was very well tolerated both as monotherapy and in combination with interferon. Myrcludex B has shown strong single agent efficacy against HDV. 6 out of evaluable 7 patients experienced >1 log10 HDV RNA decline at week 24; 2 patients became HDV RNA negative and in further 2 the values dropped below the limit of quantification. In the combination arm, all patients had HDV RNA decline and 5 were HDV RNA negative at week 24. Importantly, ALT normalized in 4 Myrcludex B monotherapy patients at week 24.

These results indicate biological activity of a non-interferon drug for the treatment of HDV infection which can represent a major breakthrough in the management of this most severe form of viral hepatitis”, said Heiner Wedemeyer, Professor of Hannover Medical School, Germany, and Chairman of MYR`s clinical advisory board.

Chronic viral hepatitis B is one of the major problems facing healthcare systems globally. According to the World Health Organization, the prevalence of hepatitis B virus infection (HBV) worldwide is very high with about 350 million of them chronically infected. The market for chronic hepatitis B therapy is constantly growing, with significant unfulfilled demand for new therapies due to the lack of curative treatment options. Hepatitis delta is the most severe form of viral hepatitis affecting 15-20 million individuals worldwide. Apart from interferons, which are effective in only a minor subset of HDV patients, no treatment options are available for hepatitis delta. Myrcludex B is blocking NTCP, the receptor essential for both HBV and HDV, and thus inhibits the new infection of liver cells.

Dr. Alexander Alexandrov, CMO of MYR GmbH, said: “Myrcludex B has demonstrated the potential to become an option for controlling hepatitis delta. Moreover, more and more evidence is evolving that the inhibition of intrahepatic spread of HBV may become part of future curative regimes”.

About MYR GmbH

MYR GmbH is a German biotechnology company developing Myrcludex B, a drug for the treatment of chronic hepatitis B and D virus infections. MYR GmbH belongs to portfolio of HTGF, one of Europe largest venture funds. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver. The company was founded in 2010 and is based in Burgwedel, Germany.

About Maxwell Biotech Venture Fund

Maxwell Biotech Venture Fund (MBVF) is the first Russian venture fund fully dedicated to investments in the life sciences sector. The fund has been created with the participation of the Russian Venture Company. MBVF relies on an experienced international team of managers and financial and industry experts and has offices in Moscow and Boston. To date, MBVF has invested in nine therapeutic and medical device companies. These companies are developing products originating either from Russian research groups or licensed for commercialization in Russia from international biotech, pharmaceutical and medical device companies.

About High-Tech Gruenderfonds

High-Tech Gründerfonds invests venture capital in young technology companies with promising research results and strong potential to enable then to transform innovative ideas into entrepreneurial success. Seed financing helps startups take their R&D projects to the prototype, “proof-of-concept” or market launch phases. The fund participates with an initial €500,000; a total of up to €2 million per enterprise are available. The public-private partnership investors include the German Federal Ministry of Economics and Technology, the KfW Banking Group alongside the 18 corporate investors. High-Tech Gründerfonds manages a total investment portfolio of around €576 million (€272m Fonds I and €304m Fonds II).

 

 

  

Hepatera Ltd. announces initiation of a clinical trial investigating Myrcludex B in chronically HBV infected patients who are also infected with hepatitis delta virus (HDV). Hepatera is financed by Maxwell Biotech Venture Fund formed with the participation of RVC – Russia’s government fund of venture capital funds. Hepatera was founded in 2011 with the goal of developing and launching innovative therapeutics for the treatment of liver diseases into the Russian market. 
 
Hepatera Ltd. announces initiation of a clinical trial investigating Myrcludex B in chronically HBV infected patients who are also infected with hepatitis delta virus (HDV). Hepatera is financed by Maxwell Biotech Venture Fund formed with the participation of RVC – Russia’s government fund of venture capital funds. Hepatera was founded in 2011 with the goal of developing and launching innovative therapeutics for the treatment of liver diseases into the Russian market. 
 
Myrcludex B is a novel drug candidate for the treatment of chronic viral hepatitis B and D. The drug inhibits the entry mechanism of the virus. Hepatera is co-developing the drug with MYR GmbH, a German biotech company initially funded by High-Tech Gruenderfonds (HTGF), one of Europe’s largest venture funds.
 

Stephen Locarnini, Head of Research at the Victorian Infectious Diseases Reference Laboratory, and a member of MYR`s Clinical Advisory Board said: “Myrcludex B has the potential to bring benefit to this often desperate population and to change treatment standard for these patients.”

 
HDV, which is very difficult to treat, affects five to 10 percent of chronically HBV infected patients. Fast track regulatory procedures will be possible given the high degree of unmet medical need.
 
The ongoing study will investigate the effects of Myrcludex in combination with pegylated interferon, and the use of the entry inhibitor as pre-treatment before interferon therapy is initiated. The enrollment of all patients will be completed in April 2014. First results are expected in Q3 2014. 
 

„The study explores a second important indication for Myrcludex B, with a chance to achieve early market access and revenue generation,“ - said Alexander Alexandrov, Medical Director of MYR GmbH. „The results of this trial will provide additional important information on our potentially landscape-changing compound and will be used for the preparation of the pivotal studies.”

 

 

A group of 48 patients infected with the hepatitis B virus (HBV) have been enrolled in the phase IIa clinical trial of Myrcludex B by Russian biotech company Hepatera Ltd. Hepatera is financed by Maxwell Biotech Venture Fund, set up with the participation of RVC – Russia’s government fund of venture capital funds. Hepatera was founded in 2011 with the goal of developing and launching innovative therapeutics for treatment of liver diseases into the Russian market. 
 
A group of 48 patients infected with the hepatitis B virus (HBV) have been enrolled in the phase IIa clinical trial of Myrcludex B by Russian biotech company Hepatera Ltd. Hepatera is financed by Maxwell Biotech Venture Fund, set up with the participation of RVC – Russia’s government fund of venture capital funds. Hepatera was founded in 2011 with the goal of developing and launching innovative therapeutics for treatment of liver diseases into the Russian market. 
 
Hepatera is developing an innovative drug candidate - Myrcludex B - for treatment of chronic viral hepatitis B and D in close cooperation with the German biotech company MYR GmbH, a portfolio company of High-Tech Gruenderfonds (HTGF), one of Europe’s largest venture funds.
 
The objectives of the ongoing Phase IIa clinical trial are to study safety and tolerability, as well as efficacy of several dose levels of Myrcludex B in comparison to standard therapy (nucleoside analogues). One specific aim is to study efficacy parameters not influenced by the standard therapy in the majority of cases.
Preliminary results are expected in June 2014 and will be presented at international specialized conferences.
 

Dr. Alexander Alexandrov (Medical Director, MYR GmbH): “Introduction of potentially curative therapies for chronic HBV infection is awaited by the patients for a long time. We look forward to the evaluation of the results of this study which might become a significant step on the path of creating a new tool in treatment of this important disease”.

 
Chronic viral hepatitis B (CHB) is one of the major problems facing healthcare systems globally. According to the World Health Organization, the prevalence of hepatitis B virus infection (HBV) worldwide is very high with about 350 million of them chronically infected. The market for chronic hepatitis B therapy is constantly growing, with significant unfulfilled demand for new therapies due to the lack of curative treatment options.
 

Prof. Stephan Urban (University Hospital Heidelberg), originator of the technology: “The enrollment of all planned patients into this trial is a very significant milestone for the drug; the success of the molecule can change treatment standards of chronic viral hepatis B

 

Pharma Vestnik, December 17, 2012

A biotechnology company "Hepatera" organized phase Ib-IIa clinical study of Myrcludex B in specialized clinical centers in Moscow, St. Petersburg, Chelyabinsk and Samara.

Pharma Vestnik, December 17, 2012

A biotechnology company "Hepatera" organized phase Ib-IIa clinical study of Myrcludex B in specialized clinical centers in Moscow, St. Petersburg, Chelyabinsk and Samara.

According to the PR office of the company, the developed drug is a synthesized peptide chain, similar in structure to a membrane protein of hepatitis B. Due to this structure it competitively binds to receptors on liver cells and blocks the virus. "Thus, the drug candidate provides for the recovery of the liver tissue and prevents further progression of the disease and the development of complications such as cirrhosis and hepatocellular carcinoma".

"The Company intends to confirm the effectiveness of the drug against HBsAg clearance and its effect on the viral load, as well as demonstrate good tolerability and safety of the drug in the target population of patient".

It is expected that the results of the study, which was launched in Russia in the largest specialized centers, will be available by the end of 2013.

Hepatera, a Russian biotech company and part of Maxwell Biotech Venture Fund's portfolio, has announced today the inclusion of the first three patients with chronic hepatitis B in the clinical trial phase Ib-IIa of Myrcludex B. Hepatera was founded in 2011 and is focused on the development of innovative therapeutics for the treatment of liver diseases. The study is being conducted in major Russian specialized clinical centers and its results are expected in the end of 2013.

Hepatera, a Russian biotech company and part of Maxwell Biotech Venture Fund's portfolio, has announced today the inclusion of the first three patients with chronic hepatitis B in the clinical trial phase Ib-IIa of Myrcludex B. Hepatera was founded in 2011 and is focused on the development of innovative therapeutics for the treatment of liver diseases. The study is being conducted in major Russian specialized clinical centers and its results are expected in the end of 2013.

Hepatera is a resident of the Skolkovo Biomedical Cluster and has been financed by Maxwell Biotech Venture Fund. Myrcludex B, an innovative drug candidate for the treatment of chronic viral hepatitis B and D, is developed in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Gruenderfonds (HTGF), one of Europe's largest venture funds.

Despite the widespread introduction of vaccination, chronic hepatitis B remains an unsolved health problem. According to the WHO close to 2 billion people in the world are carriers of HBV, of which about 400 million are chronically ill. Every year approximately 50 million people get infected with HBV and almost 2 million people die from liver conditions caused by this infection. Co-infection with HDV which is diagnosed in about 5% of cases increases the severity of the disease doubling the frequency of complications and mortality rate, compared to monoinfection. To date there are limited options to treat the HDV co-infection.

"It is very important for us that we take part in such a large international project and have the opportunity to be the first center to evaluate the effectiveness of the Myrcludex in patients. We hope that the positive results of this clinical trial will allow the company to continue the development of the drug, which offers a new approach to the treatment of patients with hepatitis B, and will be able to significantly improve and simplify the existing treatment regimen," said Elena Volchkova, consultant for "Infectious Clinical Hospital a"- 2" of the Moscow Department of Health, Doctor of Medical Science, Head of the Department of Infectious Diseases of the Sechenov First Moscow State University, principal investigator.

"We are excited to see that Myrcludex has now moved into the clinical study in patients who might benefit from the treatment. In this study we have a particular emphasis on safety, but also looking at HBsAg levels which remain unaffected by current standard treatment regimens in the majority of patients. With the HBV receptor identified now, we hope that the results will boost the field and deliver a milestone in combating this important disease," said Alexander Alexandrov, Chief Scientific Officer at MYR GmbH.

Hepatera, a Russian biotech company founded in late 2011 with the goal to develop and launch into the Russian market innovative products for treatment of liver diseases, has recently received notification from the Russian Ministry of Health for approval to begin a clinical trial associated with a drug registration submission, and can now proceed with the clinical development of Myrcludex B for treatment of chronic viral hepatitis B in the Russian Federation.

Hepatera, a Russian biotech company founded in late 2011 with the goal to develop and launch into the Russian market innovative products for treatment of liver diseases, has recently received notification from the Russian Ministry of Health for approval to begin a clinical trial associated with a drug registration submission, and can now proceed with the clinical development of Myrcludex B for treatment of chronic viral hepatitis B in the Russian Federation.

A Skolkovo resident Hepatera has been financed by Maxwell Biotech Venture Fund created with the participation of RVC and is developing an innovative drug candidate for treatment of chronic viral hepatitis B and D in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds.

Chronic viral hepatitis B (HBV) 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. About 5% of patients with HBV 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.

The idea for Myrcludex B was developed within two renowned research institutions in Europe, the French National Institute of Health and Medical Research (INSERM) and University of Heidelberg in Germany. The lead compound blocks the penetration of Hepatitis B and D viruses into hepatocytes (liver cells) thus creating a reserve for the restoration of liver tissue and preventing disease progression as well as development of complications such as cirrhosis and hepatocellular carcinoma.

“The open randomized clinical trial of the daily use of Myrcludex B compared with entecavir in patients with HBeAg-negative chronic hepatitis B, Phase Ib-IIa” approved by the Russian Ministry of Health will be conducted by Hepatera in specialized clinical centers in major Russian cities: Moscow, Saint-Petersburg, Chelyabinsk and Samara.

Pavel Bogomolov, head of hepatology department of MONIKI named after M.F.Vladimirov, head of the Moscow regional hepatology center, leading hepatologist of Moscow region: "Despite the mass vaccination, about 1.1 million people in this country require treatment of viral hepatitis B and D each year. Unfortunately, the existing standards of care does not give the opportunity to fully address this serious medical and social problem. Given the positive results obtained in previous stages of Myrcludex B development, we have every reason to believe that a clinical trial to be conducted in a number of Russian specialized centers will be successful."

Alexander Alexandrov, Medical Director – COO at MYR GmbH: “This clinical trial will allow us for the first time to obtain data on the tolerability and potential therapeutic effect of Myrcludex B in patients with viral hepatitis B in need for treatment. This important step in the development of the drug became possible due to the fruitful cooperation with Hepatera and Maxwell Biotech Venture Fund and sets an example of successful cooperation between Russian and European development teams."

Yan Ryazantsev, Director of Investment and Expertise Department with RVC: "We are always glad when portfolio companies which are created with the participation of RVC meet|pass the most important milestones in their development. Despite the fact that Hepatera was established not long ago, such progress shows properly structured business strategy in the company as well as the high level of competence of its management team. Together with Maxwell Biotech team we are looking forward to the positive results of Myrcludex B studies, which will significantly advance the search for solutions of such an important health issue as chronic hepatitis."

Venture Business News, May 14, 2012

In the beginning of April, Maxwell Biotech Venture Fund created with participation of PVC announced its cooperation with the large German fund for seed investments High-Tech Gründerfonds. Dmitry Popov Managing Partner of Maxwell Biotech Venture Fund, has told VBN what it gives to both companies.

Venture Business News, May 14, 2012

In the beginning of April, Maxwell Biotech Venture Fund created with participation of PVC announced its cooperation with the large German fund for seed investments High-Tech Gründerfonds. Dmitry Popov Managing Partner of Maxwell Biotech Venture Fund, has told VBN what it gives to both companies.

Maxwell Biotech Venture Fund has been cooperating with High-Tech Gründerfonds for half a year now, why do you need an agreement on the official partnership?

First, it increases considerably the flow of interesting projects to be reviewed by our team that have passed the expert filter of the German fund.

Second, such partnership expands significantly a network of international scientific experts whom we can engage in work on the projects. The more they are, the better and in more detail we can discuss the scientific and technological basis of a project and its prospects for successful development. For example, while working on the project of our portfolio company Hepatera, we have interacted with both the leading Russian specialist, Pavel Bogomolov chief hepatologist of the Moscow Region, and foreign experts — a specialist from San-Diego and a professor from a German university.

Third, this is an opportunity for us for co-investment. We can use financial resources of our funds and partners for joint investments that will back up significantly our investment risks.

And, finally, our portfolio companies will be able to attract experience of international investment managers that will be useful not only at the development stage but when organizing a financial exit as well.

That is, now Maxwell Biotech will invest into Germany?

Not exactly. We are investing only in Russian companies but the origin of intellectual property may be international. The IP rights are regulated by a license agreement. The project development – pre-clinical and clinical trials – is conducted in Russia in accordance with the international standards. It goes in line with the philosophy of our company – Russian patients should get access to the best innovative drugs not later than the residents of other countries.

What do you think why the German fund needs this cooperation? It is well known that the Rothschild family fund co-invests with them, and you are a young Russian fund.

I think they are interested in us not only for co-investments, another  reason is that Russia has a well-developed clinical trial industry that meets all the international standards: qualified researchers, medical centers. The possibility to share financial risks and at the same time to get access to an advanced infrastructure for clinical development is a serious basis for our collaboration.

Your fund has been active for 4 years now, and in total 7 projects have been invested. Why not more?

Our fund was formed at the end of December 2008; that is why actually we started working only in 2009. About a year was spent on organizational issues: office, team formation, beginning of an active search for projects in Russia and abroad. In summer 2010, we signed the first deal. Thus, within incomplete two years of active investments, we’ve made seven deals and are planning to announce the eighth one in May. By the end of year 2013 — the fifth year of the fund’s existence — we are to double the number of invested projects, increasing it to 14. Taking into account the duration of expert examination of biotech projects and complexity of deal structure — the result is far from being poor.

Experts say that 40% of the drugs that patients take do not help. Is your fund planning to invest in any project that would increase drug efficiency?

Every drug has its individual effect, there are many projects aimed at the improvement of drug delivery, changing its pharmacokinetics and pharmacodynamics. We review such projects but they are not our investment priority at the moment.

What diseases do the Russians suffer from?

The main reasons for mortality in Russia remain oncology and cardiovascular diseases. This is precisely why our three projects — OncoMax, MetaMax and CardioNova — are focused on these areas. Infectious diseases also remain an important problem, therefore Infectex and Hepatera are dealing with its solution (drug candidates against tuberculosis and  chronic viral hepatitis respectively). Diabetes and its complications are also a special concern and NeuroMax is working in this direction.

There are so many smokers among us, do you think it’s possible to create a universal pill that would help to stop smoking for good?

As for me, I don’t smoke and it seems to me that it would be extremely difficult to create such a drug. If a person lacks will power and determination to get rid of the bad habit, then neither therapy patch nor electronic cigarette nor any drug will help him.

Which of your products are closest to the market?

The most advanced projects — NeuroMax, Infectex, Hepatera, their drugs are under the clinical trials. MetaMax and CardioNova are also close to this stage. The clinical trials last from 2 to 5 years, and another year will be needed for all the registration procedures. In case of successful clinical results, we’ll see these drugs in the market in 3-6 years.

Do you receive many applications for investments?

For the period of our fund’s activity, we have received about a thousand projects. But the majority of them do not meet our investment criteria. In Russia, there are quite a lot scientific activities but not many of them can become the basis for a business project. Apart from the development itself, the business project should have a clear IP position, an estimated market volume and an adequately determined need for the product. And of course the project team is also very important.

And how do you organize the work in your office in Boston?

The choice of Boston as a location for our international office was not ad hoc; this is the largest biotechnical cluster of the world with research centers of large pharmaceutical companies, seven large universities, world-level clinical centers and about 300 biotech companies operating there. Institutional investors and venture funds, that we have arranged effective communication also have their offices there. Our team in Boston has up to ten meetings with startup companies and projects authors a week. We are planning to expand our international presence in USA, on the western coast, and in Europe as well.

Thank you.

Venture Business News, May 2, 2012

Maxwell Biotech Venture Fund created with the participation of RVC has announced the coordinated round of investments into Hepatera, Ltd – a private Russian company, dealing with development and market promotion of innovative drugs. The investments of Maxwell Biotech Venture Fund will be forwarded for the development of an innovative drug for treatment of chronic virus hepatitis В and D.

Venture Business News, May 2, 2012

Maxwell Biotech Venture Fund created with the participation of RVC has announced the coordinated round of investments into Hepatera, Ltd – a private Russian company, dealing with development and market promotion of innovative drugs. The investments of Maxwell Biotech Venture Fund will be forwarded for the development of an innovative drug for treatment of chronic virus hepatitis В and D.

The drug development will be performed in close cooperation with a German biotech company, MYR GmbH, a portfolio company of a European Venture Fund High-Tech Gründerfonds. The fund itself, listed in TOP-15 venture companies of the world in volumes of investments in biomedical projects, participates in the investment round together with Maxwell Biotech Venture Fund.

Hepatera, founded in September 2011, is a member to the biotech holding Maxwell Biotech Group, and since December 2011 has been a resident of the Skolkovo Innovative Center Biomedical Cluster. The amount of investment is not disclosed; however, it is known that the policy of High-Tech Gründerfonds implies investment from 500 thousand Euros into projects at the seed stage.

 

Today, April 4th, Maxwell Biotech Venture Fund (MBVF), founded with the participation of RVC, and High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds, signed a Letter of Intent between the two funds during a joint press conference in Moscow.

Today, April 4th, Maxwell Biotech Venture Fund (MBVF), founded with the participation of RVC, and High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds, signed a Letter of Intent between the two funds during a joint press conference in Moscow.

In the Letter of Intent, the funds agree that it is in their best interests to develop a strategic partnership for investing in the life sciences sectors of Russia and Germany and identify a framework for cooperation and partnership. This has been conceived with the intention of both funds to coordinate their efforts and to leverage their respective country expertise and resources to facilitate innovation in medicine. Such innovation will be directed toward addressing the high unmet medical needs of patients and their providers, and to further building the strength of their respective country’s healthcare industries.

Bernd Goergen, Senior Investment Manager of the High-Tech Gründerfonds: "Joining forces with the right people is a key success factor for establishing and maintaining a sustainable business not only in biotechnology, but also in the venture area. Therefore we are more than happy to welcome MBVF into our partner network and look forward to a steadily growing number of successful projects to the mutual benefit of our portfolio companies, our organizations, and our markets."

According to the Letter of Intent, MBVF and HTGF intend to explore all possibilities for effective collaboration, such as identification of strategic areas of common interest (including priority therapeutic and diagnostic categories), choice of key opinion leaders and experts in Russia, Germany and other parts of the world available to both funds, joint evaluation of potential new investment opportunities, co-investment in existing portfolio companies of the funds, as well as exchange of information relating to market data, regulatory requirements and other material relevant to the development of biotech and pharmaceutical products in Russia and Germany.

Both MBVF and HTGF are actively pursuing investment opportunities in life science companies that develop novel therapeutics, diagnostics, medical devices and related products and technologies. Recently, the two funds announced the execution of definitive agreements for their first collaboration, which resulted in investments in MYR GmbH, a portfolio company of HTGF, and Hepatera LLC, a MBVF biotech company and resident of the Biomedical Cluster of Skolkovo Innovation Center, that was established to develop and bring to market innovative drugs for liver diseases. Reflecting the strong experiences in the MYR-Hepatera negotiations, the funds wish to collaborate to identify and co-invest in further mutually beneficial opportunities.

Dmitri Popov, managing partner at Maxwell Biotech Venture Fund: “We are very pleased with the development of our collaboration with HTGF, which is not limited to a single transaction, and are confident that this agreement will significantly simplify our further cooperation. Given the recent successful experience, we hope to build a mutually beneficial and effective partnership which will result in further venture capital market developments and, ultimately, the appearance of innovative products and technologies."

Under the signed Letter of Intent, the collaboration between HTGF and MBVF may result in co-investment in start-up companies, in particular in cases where: (i) there are potential synergies arising from the research activities of the Funds’ portfolio companies, (ii) advantage can be taken of access to each country’s medical infrastructure, such as Russian medical centers for conducting clinical trials of new and innovative treatments, medical devices and diagnostic tests, and, (iii) products under investigation have particularly strong medical and commercial potential in the Russian and German healthcare markets.

Yan Ryazantsev, Chief Investment Officer with RVC: "One of the areas for RVC’s investment activities is increasing the number of joint transactions between market participants. This allows the funds to exchange best practices while working on a project together and gives access to knowledge and technologies of other funds, which results in significant acceleration of professional teams involved in completing transactions. Cooperation between "Maxwell Biotech" and HTGF is a good example of the expert and technological interaction necessary in the biotechnology industry. MBVF has already achieved a strong presence in the international marketplace and RVC sees this collaboration as a significant indicator confirming that our backed fund is able to build up an effective cooperation not only with Russian funds and development institutions, but also with foreign partners."

Co-Invests with Germany’s Public/Private High-Tech Gründerfonds, one of Europe’s Top Venture Funds

Co-Invests with Germany’s Public/Private High-Tech Gründerfonds, one of Europe’s Top Venture Funds

Maxwell Biotech Venture Fund (MBVF), founded with the participation of the Russian Government’s Russian Venture Company, announced today its first investment involving the High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds. MBVF’s investment committee approved the terms and the amount of an investment in a newly formed Russian biotech company, Hepatera, and a concurrent investment in theGerman biotech company MYR GmbH (“MYR”), a portfolio company of HTGF. Hepatera is going to use the funding to co-develop its first drug candidate, Myrcludex B, aimed at the treatment of chronic viral hepatitis B and D, in close partnership with MYR.

"Hepatera", Ltd. is a private Russian biotech company, that was founded in September 2011 and became a resident of the Biomedical Cluster at Skolkovo Innovation Center in December 2011. The company’s main goal is to develop and bring to the market innovative drugs for the prevention and treatment of liver diseases.

Dmitri Popov, managing partner at Maxwell Biotech Venture Fund: "Investing in Hepatera is not only a successful complement to the existing project portfolio of the fund, addressing one of the most serious medical and social problems, but also our first experience of investing alongside High Tech Gründerfonds. This is Germany’s pre-eminent public/private high tech fund, and we are pleased to be associated with one of Europe’s largest venture funds that was listed as one of the world’s TOP-15 venture funds, based on total investments in biomed projects in 2011."

Yan Ryazantsev, Director of Investment and Expertise Department with RVC: "Attracting the participation of the global venture capital market into Russia, promoting abroad the products and services of Russian venture industry participants and innovative companies, as well as forming a sustainable positive attitude in foreign markets towards Russian innovation companies — these are the three components of success for Russia’s venture business on a global scale. And we are very pleased with the fact that the investment in Hepatera will help meet them.”

Bernd Goergen, Senior Investment Manager of the High-Tech Gruenderfonds adds: "We are extremely excited about our first investment together with Russian venture capitalists. Throughout the whole process we experienced an extraordinarily high level of sector competence, professionalism and fairness from Maxwell Biotech. The resulting mutual trust will form the basis for developing together not only a sustainable business with a highly innovative hepatitis drug, but also paves the way for additional fruitful collaborations."

 

About Myrcludex B

The prevalence of HBV (hepatitis B) infection in the world is very high: about 2 billion people are carriers of HBV, of which about 350 million are chronically ill. In some 5% of individuals with chronic hepatitis B virus the presence of hepatitis D is revealed. Such co-infection results in more severe and rapid progression of liver disease. Currently there is no drug approved to treat patients with hepatitis D.

The idea for Myrcludex B was developed within two renowned research institutions in Europe, the French National Institute of Health and Medical Research (INSERM) and University of Heidelberg in Germany. The lead compound blocks the penetration of Hepatitis B and D viruses into hepatocytes (liver cells). By treating with an entry inhibitor, new infection of constantly-evolving, healthy hepatocytes may be blocked and the number of infected cells should significantly decline within a few months. The immune system could then regain control over the infection and long-term treatment with viral replication inhibitors omitted or significantly shortened. Both HBV and HDV use the same receptor to enter the cell. The results obtained to date in the course of developing Myrcludex B show the effectiveness of this approach against both HBV and HDV in cell and animal models, as well as an excellent safety and pharmacokinetic profile in the recently completed Phase 1 clinical study.

Overview

"Hepatera" is a private biotech company. The main activity of the Company is the search for and evaluation of promising drug candidates, as well as development and bringing to the Russian market safe and effective drugs for the treatment of liver diseases. First product (Myrcludex B) is aimed at the treatment of chronic
hepatitis B and D. Myrcludex B is based on the research of the University Ruprecht-Karls-Universität Heidelberg, and is being developed in the framework of international cooperation with the biotechnology company MYR, GmbH (Germany).