According to the analytical report prepared by Synergy Research Group and devoted to the market of clinical trials in Russia, Valenta ranks the first among domestic pharmaceutical manufacturers by the number of clinical studies initiated in the third quarter of 20151.
In Q3 2015, the Ministry of Health of Russia issued 203 permissions for various kinds of clinical trials, which demonstrated a 13% increase in comparison with the similar period of the last year, at that 83% of the new studies were initiated in eight therapeutic areas. The maximum number was registered in the area of Oncology – 28 clinical trials; 25 – in Pulmonology; 10 - in Infectious and Parasitic Diseases, and 10 – in the area of Locomotive System and Neurology; 9 new trials were initiated in the area of Gastroenterology, 8 – in Endocrinology and 5 – in Urology2.
From July to September 2015, Valenta received permissions to carry out three new registration Phase-3 studies. One of them was devoted to the effectiveness and safety of the Company’s medicine included in its gastroenterological portfolio, in comparison with another antispasmodic for symptomatic treatment of pain caused by functional diseases of gastrointestinal and biliary tracts. Valenta plans to enroll more than 200 patients in about 20 clinical centers for the trials. Within the two other studies, therapeutic equivalence of the new medicinal form included in the Company’s anti-catarrhal portfolio is studied, and each of them stipulates participation of about 150 patients in more than 15 clinical centers.
Valenta considers the creation of new effective medicines its key priority. Currently the Company actively invests in the development of its portfolio of products, medical projects and healthcare innovations. In 2015, the amount of investments in research activity made hundreds millions roubles. The basic therapeutic areas of research are: Neuropsychology, Urology, Gastroenterology, Immunology, CNS diseases, Virology and Antibacterial Therapy. Valenta aspires to develop products from the first to the last phase of trials, studying the product safety and effectiveness at all phases. All studies are conducted according to the good clinical practice (ICH-GCP) and in compliance with high ethical standards.
Askar Bikkenin, Executive Director, JSC Valenta Pharm: “Development of innovative methods to combat various diseases is one of the first priorities for Valenta. We develop new medicines aimed at improvement of Russian patients’ quality of life based on the main criterion – the proven high clinical efficacy at the lowest risk of side effects. We thoroughly analyze the needs of domestic public healthcare and strive to find innovative solutions to meet them.”
- 1 Data from Synergy Research Group (Pharmaceutical Bulletin, No.35 (822), November 3, 2015, “Study more and more”, p.10).
- 2 Pharmaceutical bulletin, No.35 (822), November 3, 2015, “Study more and more”, p.10.