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Human Stem Cells Institute Signs Milestone Sales Agreement for the Innovative Drug Neovasculgen®

Moscow, 26 March 2013 – Human Stem Cells Institute OJSC (“HSCI”, MICEX: ISKJ), one of the leading Russian biotech companies, today announced that an agreement has been signed to supply the Russian pharmaceutical company Sotex Pharm Firm with the innovative drug Neovasculgen®, developed by HSCI for treatment of Peripheral Arterial Disease.

The sales agreement was signed by the two companies on March 25, 2013, and covers three commercial years with an extension option. A delivery schedule has also been agreed. During the first year, sales under this agreement will total 211.75 million rubles.

HSCI received marketing authorization for Neovasculgen® in December 2011 and following certification of the drug’s first batches it was made available for sale on the Russian market (October 2012).

Sotex Pharm Firm, part of Protek Group, is one of the largest players on Russian pharmaceutical market and has extensive experience in bringing innovative medicines to market.

Neovasculgen® is a first-in-class drug intended for the treatment of patients with Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI). This disease is caused by atherosclerosis (a thickening of artery walls and subsequent reduction of blood flow). It is believed that no less than 1.5 million people in Russia suffer from this ailment. Each year approximately 144,000 patients are diagnosed with CLI and 30,000-40,000 patients undergo amputations.

Neovasculgen® introduces a new approach to the treatment of ischemia – the use of an evolutionarily programmed process of blood vessel creation and growth. The action mechanism is called therapeutic angiogenesis.

According to HSCI’s forecasts, by 2017 the market volume for Neovasculgen® in Russia could exceed 1.5 billion rubles.

In addition to the Russian market, HSCI intends to make Neovasculgen® available on other markets as well. In February 2013 marketing authorization was receive for Neovasculgen® in Ukraine and work is already underway to obtain authorization for the drug in a number of other CIS countries.

Artur Isaev, Ernst & Young 2012 Entrepreneur of the Year in High Technology and General Director of HSCI, commented on the signing of the agreement: “We believe that cooperation in the marketing of HSCI’s new drug will be useful to both companies. Sotex will carry out an important part of the work related to the development of the market for the innovative drug Neovasculgen®, which will allow HSCI to focus more on the realization of other projects and developments.”
Over the course of the past several years HSCI has made substantial investments not only in the development of Neovasculgen® but also in the development of other products. At present HSCI plans to focus its efforts on the launch of a new laboratory and production complex for the production of medical and pharmaceutical products and the provision of services in the fields of regenerative medicine and medical genetics. Another important part of the company’s plans for the near future is the realization of a socially significant project to create a Russia-wide network of centers providing medical genetic diagnostics and consulting services and introducing into practice the use of a DNA array specially developed by HSCI for the diagnosis of a number of orphan diseases which are known to be prevalent in Russia.

Full Version of the Press Release (228 kb)

26 March 2013