Ad-hoc | 27 March 2006 08:31
Rhein Biotech Announces First Product Approval for Quinvaxem™ Vaccine
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The issuer is solely responsible for the content of this announcement.
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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
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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
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