Clinical Trials in Russia 4th Quarter 2007

Released on: February 18, 2008, 7:10 am

Press Release Author: Synergy Research Group (SynRG)

Industry: Pharmaceuticals

Press Release Summary: On February 18, 2008 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. During the Q4 2007 the
RZN approved 174 new clinical trials in Russia showing a 23% increase over the Q4
2006. The main growth was contributed by international multi-center clinical trials,
which increased by 54% and accounted to 131 studies in Q4 2007, - the maximum number
during the whole history of clinical trials in Russia.


Press Release Body: On February 18, 2008 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.

During the Q4 2007 the RZN approved 174 new clinical trials in Russia showing a 23%
increase over the Q4 2006. The main growth was contributed by international
multi-center clinical trials, which increased by 54% and accounted to 131 studies in
Q4 2007, - the maximum number during the whole history of clinical trials in Russia.

The share of international multi-center trials in Q4 2007 stood at 75%, and the
shares of local and bioequivalence studies stood at 18% and 7%, respectively. The
lions share of clinical trials in Russia is conducted by foreign sponsors, in Q4
2007 82% of the total number of studies were initiated by 71 manufacturers from 20
countries.

The total number of patients to be enrolled in clinical trials started in Q4 2007 is
23,745, which is 2.7 times more than in the corresponding quarter of the past year.
The minimal number of subjects is four, and the maximum number of patients is 5,000.
The shortest trial lasts two months, while the longest will take five years.

The French sanofi-aventis holds the first place among foreign sponsors in terms of
number of trials initiated in Q4 2007. It is followed by American Merck & Co.,
British GlaxoSmithKline slips to the third place this quarter. Russian sponsors are
led by pharmaceutical company LEKKO, it is followed by Microgen and Schelkovsky
Vitamin Plant.

21 of 44 new drugs approved by Food and Drug Administration (FDA) and European
Medicine Agency (EMEA) in Q4 2007 were, or are being tested in the clinical trials
in Russia. Top six therapeutic areas of the clinical trials started in Russia in Q4
2007 are: oncology, cardiovascular, respiratory; nervous, gastro-intestinal and
endocrine disorders.
According to the RZN data, as of 9 January 2008 there are 854 investigator sites in
Russia, 27 of which were accredited by the RZN in Q4 2007.

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, 4-Magistralnaya Ul., 123007 Moscow, Russia. Tel. +7 495 643
1186. Fax +7 95 643 1187

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