Crucell Announces Product Approval in Korea for Quinvaxem(TM) Vaccine
Leiden, The Netherlands / Seoul, Korea, March 27, 2006 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: SW CRX) announced today that the Korea Food and Drug Administration (KFDA) has awarded licensure to Quinvaxem(TM), a fully liquid pentavalent vaccine to be produced by Crucell in Korea. Quinvaxem(TM) was co-developed with Chiron Corporation, which provides four of the five components as bulk.
Quinvaxem(TM) combines antigens for protection against five important childhood diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b, one of the leading causes of bacterial meningitis in children. It is the first internationally available fully liquid vaccine containing all five of the above antigens to reach the market, offering a major advantage in terms of convenience of use. Supranational organizations are major customers for combination vaccines, which are used in mass vaccination programs in developing countries.
The Quinvaxem(TM) product dossier was filed in 2005 with both the KFDA and the World Health Organization (WHO). The paediatric vaccine addresses an important unmet medical need in many parts of the developing world. As a next step, the WHO is expected to finalize its own review in order to grant WHO ’pre-qualification’, a pre-requisite for the combination vaccine to be made available to supranational purchasing organizations.
Crucell will start production of the Quinvaxem(TM) vaccine immediately at its Korean subsidiary. First sales are expected in the second half of 2006. The current demand exceeds 50 million doses, with the annual demand expected to increase to more than 150 million doses per year over the next five years.
Ronald H. Brus, Crucell’s CEO commented: “This approval by the Korean FDA is an important first step towards becoming a major supplier in paediatric vaccination programs for the developing world. The approval of Quinvaxem(TM) is an important milestone for us, which fits perfectly in our strategy to become a leading vaccine player.”
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: SW CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell’s core portfolio includes vaccines against hepatitis B and virosomal influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine on the market. The Company has a broad development pipeline, including both early-stage products and products almost ready to go to market. Several Crucell products are based on its unique PER.C6® production technology. The Company licences this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, elsewhere in Europe, and in Korea. The Company employs about 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 April 14, 2005, and the section entitled “Risk Factors”. The company prepares its financial statements under generally accepted accounting principles in the United States (US GAAP).
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- Harry Suykerbuyk
- Director Investor Relations & Corporate Communications
- Crucell N.V.
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