Released on: November 12, 2007, 11:14 am

Press Release Author: Synergy Research Group (SynRG)

Industry: Pharmaceuticals

Press Release Summary: In the 3rd Quarter 2007 RosZdravNadzor (RZN) has issued 141
approvals for conducting new clinical trials, which is 2% more than in Q3 2006.

Press Release Body: On November 12, 2007 Synergy Research Group (SynRG), a
Russia-based CRO, presented the current issue of its Orange Paper, a regular
analytical report on the market of clinical trials in Russia. The report contains
hundreds of figures as well as dozens of tables and pictures covering various
aspects of the Russian Clinical Trials 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 - few of the key strategic objectives
of SynRG.

According to SynRG Orange Paper, in the 3rd Quarter 2007, the overall volume of the
clinical trials in Russia and its basic parameters are generally the same as in the
corresponding quarter of the last year. In the 3rd Quarter 2007 RosZdravNadzor (RZN)
has issued 141 approvals for conducting new clinical trials, which is 2% more than
in Q3 2006. In comparison with the last year the proportion between international
clinical trials, local clinical trials and bioequivalence studies remains unchanged.


There is a minor increase in the share of Russian sponsors in the total number of
clinical trials which accounts for 31% of the total number of studies initiated
during Q3 2007. Among the foreign sponsor countries the majority comes from the
United States (30% of clinical trials), Germany (10%) and Great Britain (7%).
An increase in the number of Phase II trials (by 57%) and a decrease of the number
of phase III trials (by 18%) is observed. The total number of patients who are
planned for recruiting has decreased by 12% (from 16,340 to 14,431), compared with
the Q3 2006.

Among foreign sponsors the leader is Bristol-Myers Squibb (7 new studies in 95 sites
recruiting 2,033 patients in total), among Russian sponsors - OOO ROZFARM.
Among the therapeutic areas the maximum number of clinical trials have been
initiated in oncology (29 studies in 230 sites with total number of 1,784 patients),
on the second place are cardiovascular trials (18 trials, 220 sites, 4851 patients),
then go studies in nervous system diseases (15 trials in 84 sites recruiting 1,112
patients).

In the 3rd Quarter 2007 the US Food and Drug Administration (FDA) approved 7 new
drugs which had been tested in clinical trials conducted on the territory of Russia.
European Agency for the Evaluation of Medicinal Products (EMEA) approved 5 marketing
applications for drugs which had been tested in clinical trials in Russia.

32 new investigator's sites in Russia were approved by the RZN for conducting
clinical trials, thus the current number of investigative sites in Russia is 800.

Synergy Research Group (SynRGT) is a Russian contract research organization, which
has been successfully operating all over Russia and the CIS member-states since
2002. SynRGT 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 warehouse in Moscow, with the total area of 180
square meters. Today, Synergy Research Group is represented in Moscow,
Saint-Petersburg, Novosibirsk, Yekaterinburg and Almaty (Kazakhstan). The company's
headquarters are in Moscow.


Web Site: http://www.synrg-pharm.com/en/article11.htm

Contact Details: 11, Ul. 4-Magistralnaya, 123007 Moscow, Russia/ tel. + 7 495 643
1186/ fax +7 495 643 1187