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Regulatory Filings • Mar 27, 2006

News Details

Ad-hoc | 27 March 2006 08:31

Rhein Biotech Announces First Product Approval for Quinvaxem™ Vaccine

Ad hoc announcement transmitted by DGAP – a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. —————————————————————————— Rhein Biotech Announces First Product Approval for Quinvaxem™ Vaccine Maastricht, the Netherlands/ Seoul, Korea, March 27, 2006 – Rhein Biotech (WKN: 919 544, Geregelter Markt: RBO) announced today that the Korea Food and Drug Administration (KFDA) has awarded licensure to Quinvaxem™, a fully liquid pentavalent vaccine co-developed with Chiron Corporation, which provides four of five components as bulk, and produced in Korea. Quinvaxem™ 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™ 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. Rhein Biotech will start production of the Quinvaxem™ vaccine immediately at its Korean facilities. 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. About Rhein Biotech NV, a Crucell Company Since February 2006 Rhein Biotech is a Crucell Company. 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. Crucell N.V. Harry Suykerbuyk Director Investor Relations and Corporate Communications Tel. +31-(0)71-524 8718 h.suykerbuyk@crucell.com (c)DGAP 27.03.2006 ————————————————————————— language: English emitter: Rhein Biotech N.V. Oude Maasstraat 47 6229 BC Maastricht Niederlande phone: +31 433 56 78 9-0 fax: +31 433 56 78 9-9 email: patrik.richard@bernabiotech.com WWW: www.bernabiotech.com ISIN: NL0000230324 WKN: 919544 indexes: stockmarkets: Geregelter Markt in Frankfurt (General Standard); Freiverkehr in Berlin-Bremen, Stuttgart, München, Hamburg, Düsseldorf End of News DGAP News-Service —————————————————————————