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Last updated on May 29, 2012 at 14:51 EDT

OPK Biotech Develops Research and Production in Russia

October 6, 2009
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MOSCOW, October 6 /PRNewswire/ — At the close of the 20th century, the
lack of donor blood and the safety of blood medication became one of the most
critical problems in the area of health protection on a global scale. The WHO
(World Health Organization) started the Global Database on Blood Safety,
GDBS. Experts also determined the main problems in the area of blood
transfusion: the necessity of donor blood and other blood products, the
limited access to materials used in hemotransfusion and blood safety.
Nowadays the situation has improved, but mainly in western developed
countries, which can hardly be said about other developing countries.

Earlier there were attempts to struggle against this originated problem,
by means of the creation of chemical blood analogues. This method had a wide
application in Japan and in the USA, but during clinical trials of chemical
drugs, a scandal arose in the USA. The reason was the high reactogenicity of
drugs, as a result of which it was forbidden.

The Russian company OPK Biotech, controlling the American
biopharmaceutical company Biopure Corporation, has worked out two main
products – Hemopure (for human treatment) and Oxyglobin (applied in
veterinary medicine) – offering practical alternatives to these methods.

Already in the beginning of the 1990s, basic production methods for
biological analogue of human blood were worked out. These methods underlay
innovative blood medicines, like Hemopure and Oxyglobin, originated from
cattle blood, and functioning as an oxygen bridge to organisms during
critical situations like anemia, ischemia or severe traumas. At that time
Hemopure and Oxyglobin already existed in medicine, but it took the
authorities permission to deliver the products to the market.

In 1998, the Center for Veterinary Medicine, U.S. Food and Drug
Administration (FDA) permitted to apply Oxyglobin in the USA. And in 1999,
the European Committee permitted to apply Oxyglobin in the countries of the
EU. This drug has been sold since 1998.

In June 2005, the U.S. Naval Medical Research Center (NMRC) inquired the
U.S. Maritime Force for permission to test Hemopure in the frameworks of
surgical traumatology by means of the Federal budget. In December 2006,
during a vote in the Blood Product Advisory Committee (BPAC) all surgeons
supported such a particular testing. The Committee approved pre-clinical
testing of Hemopure. Since then, the NMRC started to stock up on Hemopure.
The contract with the NMRC is still ongoing. In 2009, the FDA got an inquiry
for clinical application of Hemopure in USA.

At the end of August 2009, Biopure Corporation was finally taken under
OPK Biotech’s control, a part of the United Industrial Corporation (OPK). OPK
Biotech has high-qualified specialists and managers in the domain of
biochemistry and finance. All top-managers possess academic degrees and
scientific education from leading universities in the USA. Most of the
managers also have great experience in the medical domain. In particular, the
Member of the Board of Directors is a former U.S. Surgeon General, named

Everett Coop.

Today, OPK Biotech disposes of certificated production facilities, with
the capacity to manufacture about 100 thousand doses (250ml) of Hemopure, 347
thousand doses of Oxyglobin (125 ml), or 647 thousand doses of Oxyglobin (60
ml) a year. The company also has all estimated and technical documents
required for the construction of factories, able to produce more than 500
thousand doses of Hemopure a year.

OPK Biotech aims at expanding scientific explorations, increasing the
production base by means of new high-technological productions in different
regions in the world, as well as developing global marketing to promote their
high-technological products.

In particular, OPK Biotech and OPK plans imply the development of
research-and-production complex in Russia, as well as further perfectionning
of these technologies with the participation of Russian scientists and
specialists.

About OPK

United Industrial Corporation (OPK) is a diversified holding company with
total value of assets of more than US$13 billion. OPK develops and manages an
investment portfolio in major sectors of the Russian economy, including the
financial sector, real estate development, shipbuilding, mining and media.
For more information please visit the OPK website http://eng.opk.ru/

SOURCE OPK


Source: newswire