Clinical Trials in Russia 2nd Quarter 2007

Released on = July 25, 2007, 9:13 am

Press Release Author = Synergy Research Group

Industry = Pharmaceuticals

Press Release Summary = According to SynRG Orange Paper, In the 2nd Quarter of 2007,
The Federal Agency for Health Care and Social Development (Roszdravnadzor, or RZN)
issued 114 permits to conduct clinical trials in Russia. This is 13% as low as in
the second Quarter last year; at the same time, the number of international
multi-center clinical trials became 25% as low, and the number of local and
bioequivalence studies grew inconsiderably.

Press Release Body = On July 25, 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 11 Tables and 9 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 Synergy Research Group.

According to the report, In the 2nd Quarter of 2007, The Federal Agency for Health
Care and Social Development (Roszdravnadzor, or RZN) issued 114 permits to conduct
clinical trials in Russia. This is 13% as low as in the second Quarter last year; at
the same time, the number of international multi-center clinical trials became 25%
as low, and the number of local and bioequivalence studies grew inconsiderably.

As a result, the contribution made by Russian sponsors grew by 7% as compared to the
second Quarter of 2006 and made up 35% of the total volume of the clinical trials
market in Russia. Study sponsors were 72 companies from 23 countries including
Russia, which was represented by 22 companies. The leader among foreign countries
participating in the clinical trials market is the US (17%) followed by Switzerland
(11%) and Germany ranking third with its 7%.

As many as 284 medical institutions will take part in trials initiated in the 2nd
Quarter of 2007, which is just over one third of the total number of study sites
accredited by RZN for conducting clinical trials. Over 50% of them are located in
Moscow and Saint-Petersburg, which is another confirmation of the unequal usage of
regional clinical sites. Over 10,000 patients will take part in the trials, and the
average trial duration will be 19 months.

The leader among foreign sponsors is Hoffmann-La Roche (10 clinical trials, 89 sites
and 1,042 patients), and the leader among Russian sponsors is ZAO Severnaya Zvezda
(The Northern Star).

In the 2nd Quarter of 2007 FDA approved 27 new drugs with four of them being tested
in clinical trials in Russia. During the same period, the European Medicine Agency
(EMEA) approved of 43 marketing applications for drugs with six of them also being
or having been tested in clinical trials in Russia.

In the 2nd Quarter of 2007 RZN inspectors conducted 12 regular audits of clinical
trial quality and accredited 18 new study sites. FDA carried out five inspections in
the territory of Russia for the first six months; in three cases, it reported on NAI
(No Action Indicated), and in other cases - on VAI (Voluntary Action Indicated).

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. The company's headquarters
are in Moscow.


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

Contact Details = Igor Stefanov
office@synrg-pharm.com
tel. +7 495 643 1186
11, 4-Magistralnaya Ul., 123007 Moscow, Russia

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