Russian investment vehicle sets sights on innovative drugs

Russian state-owned nanotechnology giant Rusnano is hoping to break into the pharmaceutical sector with sizeable investments in firms seeking to produce innovative drugs. Rusnano has been ploughing hundreds of millions of dollars into pioneering pharma companies with the aim of growing Russia’s domestic drug production, and making a tidy return by licensing drugs to foreign partners.

This is part of Russia’s State Strategy Pharma 2020, which has the goal of the increasing domestically produced drugs’ share of the Russian market by up to 50% by 2020. The strategy also stipulates that 60% of these drugs should be innovative, meaning that they were manufactured using biotechnology and other modern technologies.

As part of these plans, Rusnano has recently signed a series of major agreements with foreign pharmaceutical and biotech companies, as well as investment funds. One such agreement is Rusnano’s undertaking with longtime US partner and venture capitalists Domain Associates to invest up to $93 million (£59 million) in US companies Marinus Pharmaceuticals, Lithera and Regado Biosciences. These companies are working on drugs to treat a number of diseases.

Innovation in medication

Marinus is currently working on an epilepsy treatment, which is based on stabilised nanoparticles to deliver the drug ganaxolone. The therapy has completed Phase 2 clinical trials and shown a reduction in seizures. The firm is also looking at whether the therapy can treat alcohol- and drug-dependency.

Meanwhile, cooperation with Rusnano will allow Regado Biosciences to move its lead product, REG1, into Phase 3 trials. This unique two-component anticoagulant system gives surgeons exquisite control over a patient’s blood clotting. REG1 consists of two nucleic acid aptamers. The first aptamer binds to a blood clotting factor, preventing clot formation. The second aptamer binds to the first, inactivating it and restoring normal clotting. This drug will hopefully reduce the time patients spend in the operating theatre.

As well as helping to pay for clinical trials in the US and Russia, the funding will also cover the registration of successful drugs. The rights for the production and sales of new drugs will be transfered to the specially established NovaMedika company.

Cash injection

This agreement is part of a larger deal, between Rusnano and Domain signed last year. This venture will involve joint investments in the design of innovative drugs with a view to producing them in Russia.

Around $760 million will be invested in more than 20 US biotech companies, which will focus on the development of drugs for the treatment of heart disease and cancer. The majority of funding for the project is expected to be provided by Rusnano; however, the exact sum has not been disclosed.

According to Olga Shpichko, Rusnano’s managing director, the company will be concentrating on developing drugs for the treatment of incurable or intractable diseases. This means that the firm will only invest in companies that have a molecule in late stage clinical trials. In addition to the agreement with Domain, Rusnano is currently involved in a number of other major innovative drug projects.

Casting its net wide

The company is also working with the Russian research and development complex, ChemRar, the Center of High Technologies, to develop and potentially launch up to 15 innovative drugs. These drug candidates are currently in pre-clinical and clinical trials and designed to treat a range of illnesses, such as AIDS, hepatitis C, central nervous system disorders and pancreatic cancer.

At the same time, Rusnano is also working to create next-generation drugs with the UK-based Xenetic Biosciences, which has a number of platforms to deliver proteins and other biotherapeutics. Rusnano acquired a controlling stake in Xenetics in late 2011.

Tatiana Nikolenko, Rusnano’s director of infrastructure programmes, says that all the company’s projects primarily focus on the Russian market. Nevertheless, it also hopes to launch drugs onto the world market. She adds that Rusnano will be looking for partners to license successful drugs to.

Big risks, big returns

Rusnano says that it recognises that developing innovative drugs is risky, as it can take 10 to 15 years to see a return on investment. However, it says that the paucity of competitors in the field means any successes are likely to be substantial.

Analysts note that Rusnano has its eyes on a potentially lucrative area of the pharmaceutical  market, as demand for innovative drugs has significantly increased in recent years. The Russian Association of Pharmaceutical Producers says that numerous domestic and foreign pharmaceutical producers have already expressed an interest in Rusnano’s ventures.

Sergey Lepehin, a professor of the Russian Cancer Research Center, says Rusnano is working on some interesting anticancer nanotechnologies. However, he adds that it is still much too soon to talk about their effectiveness, as they’re still in clinical trials. He also notes that nanotechnologies is a promising future avenue for the pharmaceutical industry.

Sergey Seredennik a professor at the Zakusov Research Institute, one of Russia’s leading pharmacology institutes, is of the same opinion. He points out that nanotechnology is already enabling the creation of new and unique drugs that can act on specific targets with pinpoint accuracy.

To date, R&D activity in the Russian pharmaceutical industry has been limited as it has been constrained by its scientific research, business expertise and patent protection regime. Industry has suffered from long-term under-funding in the Soviet era and state support evaporated after it’s collapse in 1991. Perhaps Rusnano can start to turn the tide.