Subscribe to news

HSCI RECEIVES MARKETING AUTHORIZATION FOR NEOVASCULGEN® IN UKRAINE

Moscow, 28 February 2013 – Human Stem Cells Institute OJSC (“HSCI”, MICEX: ISKJ), one of the leading Russian biotech companies, today announced that on February 26, 2013, the Ministry of Healthcare of Ukraine issued marketing authorization (Registration Certificate No.899/13-00200000) to HSCI for Neovasculgen®, a drug intended for treatment of Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI). The dossier for marketing authorization was filed with the Ministry of Healthcare on March 14, 2012.

Artur Isaev, General Director of HSCI, commented: “Ukraine is an important part of the innovation development strategy of the Human Stem Cells Institute. This is a country with not only a good market but also with great human and scientific potential. For more than 8 years we have been developing our cooperation in the field of regenerative medicine and the development of innovative products. We not only ‘speak the same language’ but also have good scientific contacts and joint projects with the medical community of Ukraine. For these reasons, this is a high-priority and important market is for us, as assimilation of innovations is only possible in partnership with well-informed and educated specialists.”

Marketing authorization for Neovasculgen® in Russia was received on December 7, 2011 (Registration Certificate No.LP-000671). The decision by the Russian Ministry of Healthcare to include the drug in the State Registry of Medications was based on findings on the drug’s efficacy and safety reached during the pre-clinical and clinical trials. Sales of Neovasculgen® began on the Russian market in late 2012.

Neovasculgen® is designed to treat patients with Peripheral Arterial Disease (PAD), caused by atherosclerosis in the legs (a thickening of artery walls and subsequent reduction of blood flow). Patients with the acute form of this disease, Critical Limb Ischemia (CLI), often face the prospect of amputation.

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. The drug contains the gene of the Vascular Endothelial Growth Factor (VEGF) embedded in a plasmid vector (carrier). Neovasculgen® stimulates the growth of collateral blood vessels and, as a result, promotes a long-term therapeutic effect and improves patients’ life. According to clinical trials, the therapeutic effect following a treatment course of Neovasculgen® continues for up to two years. It has been suggested that the drug’s mechanism of action can provide an even longer effect – observation of patients will continue over the course of five years from the initial treatment.


28 February 2013