Clinical Trials in Russia. 2nd Quarter 2010.

Moscow, Russia, August 14, 2010 --(PR.com)-- On August 12, 2010 Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q2 2010, the quarterly analytical report on the clinical trial market in Russia. The report contains hundreds of figures as well as dozens of tables and pictures covering various aspects of the Russian clinical trial market. This is another step to formation of a civilized market of clinical trials in Russia and improvement of the research attractiveness of Russia for foreign sponsors, one of the SynRG’s key strategic goals.

The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 178 new clinical trials of all types including local and bioequivalence studies during the second quarter of 2010 demonstrating a 38% increase over the corresponding period of last year.

The main contribution into the total number of studies is made by multinational multi-center clinical trials, although the number of them decreased by 7% over Q2 2009 and stood at 77 new studies in Q2 2010. The number of the local clinical trials conducted in Russia by domestic and foreign sponsors increased from 27 to 68 clinical trials demonstrating a notable 152% increase over the same point in 2009.

The proportions between local and foreign companies significantly changed over the corresponding period of last year. The share of local sponsors increased by 16% and accounted up to the half of the total number of studies in Q2 2010.

Clinical trials in Russia in Q2 2010 were sponsored by companies from 23 countries. Russian sponsors are still on the top with the maximum number of initiated trials (87). American sponsors with 20 studies took the runner-up place, they are followed by German (16), Swiss (10) and the UK (7) sponsors. Top 6 is concluded by the Danish manufacturers with six new studies in Q2 2010.

The number of patients which are planned to be enrolled in the Phase I-IV trials launched in the second quarter of 2010 stood at 15,287 patients, demonstrating a 24% increase over the last year number.

The Swiss Novartis sponsoring eleven new studies is on the top of the heap in the second quarter of 2010. GlaxoSmithKline with six new trials in Q2 2010 took the runner-up place. It is followed by Johnson & Johnson sponsoring five new studies and Teva with four new studies but with the bigger number of patients and sites. The top five is concluded by Novo Nordisk also having four new studies in Q2 2010.

The Russian pharmaceutical company ZAO Rafarma sponsoring four new clinical trials ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the second quarter 2010. OOO Materia Medica with three new trials took the runner-up place. It is followed by ZAO Biocad, OAO Nizhpharm with the same number of studies (three), but different number of patients and sites. ZAO Firn M takes the 5th place with two studies.

Sixty four per cent of the new studies in Q2 2010 were conducted in the six leading therapeutic areas. The maximum number of trials (24) were initiated in Oncology; 20 clinical trials in Endocrine diseases; 13 new studies in Respiratory diseases; 11 new studies in Cardiovascular, 10 in Genitourinary diseases and 9 in Psychiatry were initiated in Q2 2010.

Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating in Russia since 2002. SynRG™ offers a broad range of services for conducting clinical trials for Russian and foreign pharmaceutical and biotechnological companies – from registration of the studies in regulatory authorities to pharmaco-economic surveys. The company has its own clinical depot in Moscow. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm, Rostov-on-Don, and also in Almaty and Astana in Kazakhstan. The company’s headquarters are in Moscow.

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