Crucell Announces Registration of Hepavax-Gene® in China
Leiden, The Netherlands - Dutch biopharmaceutical company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX), today announced that the Chinese Authorities have released Hepavax-Gene® for registration and quality control in China.
“The launch of Hepavax-Gene® is a significant advancement in the expansion of Crucell’s business in the highly strategic Chinese vaccine market,” said Ronald Brus, Crucell’s Chief Executive Officer. “Hepavax-Gene® will contribute significantly to the sustainability of our Chinese operations. The Chinese hepatitis B vaccine market is the world’s biggest market with approximately 100 million doses administered yearly.”
The prospects for Hepavax-Gene® in the Chinese private market are excellent. Hepavax-Gene® will be positioned in the high-end private market segment with a particular focus on young adults. Hepavax-Gene® possesses two decisive advantages; its production is based on Crucell’s hansenula polymorpha patented technology and it is 100% free of thiomersal. Thiomersal is a mercury based compound which, in several countries, is being phased out from vaccines given to children to avoid potentially adverse effects.
Hepavax-Gene® is a recombinant hepatitis B vaccine. Since its introduction in 1996, more than 596 million doses have been sold in over 90 countries, making it the third most used hepatitis B vaccine in the world. It is one of the World Health Organization (WHO)’s pre-qualified vaccines for immunization against hepatitis B virus (HBV). As one of seven different human hepatitis (inflammation of the liver) viruses, HBV can give rise to acute hepatitis lasting several weeks, but can also result in chronic hepatitis, cirrhosis of the liver and liver cancer. It is a highly infectious disease and endemic in many parts of the world, with more than 350 million chronic carriers. It claims about one million lives each year.
Hansenula Polymorpha Technology
H. polymorpha patented technology is a broadly applicable protein expression system. It offers a safe and robust platform for industrial scale production of pharmaceuticals including vaccines. Crucell was the first to use the H. polymorpha platform to the process development of its hepatitis B vaccine Hepavax-Gene®. The expression system has proven to be a safe, reliable system for a broad range of industrial proteins.
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global biopharmaceutical company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell’s core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6® production technology. The Company licenses its PER.C6® technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Portugal, Italy, Sweden, Korea and the US. The Company employs over a 1000 people. For more information, please visit www.crucell.com.
This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on May 7, 2008, and the section entitled “Risk Factors”. The Company prepares its financial statements under International Financial Reporting Standards (IFRS).
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