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07.10.2009

OPK Biotech Develops Research and Production in Russia

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:  www.prnewswire.com

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