Clinical Trials in Russia. 2nd Quarter 2008

Moscow, Russia, July 26, 2008 --( On July 24, 2008 Synergy Research Group (SynRG), a Russia-based CRO, presented the current issue of its Orange Paper, a regular analysis of 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 174 new clinical trials during Q2 2008, a 53% increase over the corresponding period of last year. The main contribution is still made by multinational multi-center clinical trials, their number increased by 67% over Q2 2007 and stood at 107 new studies in Q2 2008.

Clinical trials in Russia in Q2 2008 were sponsored by 42 companies from 21 countries. The maximum number of trials (58) was initiated by Russian sponsors, American sponsors (37 trials) took the runner-up place, they are followed by the German (23) and UK (16) companies, and the top six is concluded by French sponsors (10 new trials).

Eight new Phase I clinical trials were launched in the second quarter of 2008; which is one trial up from the corresponding quarter of last year. The number of the Phase II trials increased substantially from 25 trials in the second quarter of 2007 to 40 in the second quarter 2008. The number of Phase III trials demonstrated the biggest increase, the number almost doubled over last year, up from 40 to 83 studies. The number of Phase IV trials slightly decreased from 19 in Q2 2007 to 15 in Q2 2008.

Twelve thousand patients are planned to be enrolled in the Phase II-IV trials launched in the second quarter of 2008, 24% up on last year number of 9,700 patients. It’s worth mentioning that the number of Phase III subjects rose by 63% from last year’s figure.

The French sanofi-aventis sponsoring 12 new studies returned to the top of the pile in the second quarter of 2008. The German Boehringer Ingelheim, sponsoring eight new trials in Q2 2008, took the runner-up place, it is followed by the American Merck & Co. with eight trials but fewer patient number. The Canadian Patheon and American Johnson & Johnson ranked number four and five, respectively.

The Russian Valenta, sponsoring four new clinical trials enrolling 200 patients in six sites, ranked number one among domestic pharmaceutical manufacturers by the number of new studies in Q2 2008. Central European Pharmaceutical Company with three new trials took the runner-up place. It is followed by Schelkovo Vitamin Plant, Sintez and NIOPIK, all three having the same number of new studies but with different number of patients.

About two-thirds of the new studies in Q2 2008, or 67%, were conducted in the following six therapeutic areas: Neurology; Oncology; Gastrointestinal and Infectious diseases; Endocrine and metabolic diseases and Cardiology.

According to the RZN data, as of the April 3 2008 there were 877 hospitals entitled to conduct clinical trials in Russia. Twenty three new sites were accredited since last period.

According to the FDA data, as of July 1 2008, there were three FDA inspections conducted in the Russian investigative sites during 2008: two inspections were conducted in St.Petersburg, and one inspection was conducted in Yaroslavl.

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, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm and Almaty (Kazakhstan). The company’s headquarters are in Moscow.

Synergy Research Group
Igor Stefanov
+7 495 643 1186