Crucell Puts Temporary Hold on Shipments of Quinvaxem and Hepavax-Gene
(Thomson Reuters ONE) -
Leiden, the Netherlands (October 28, 2010) - Dutch biopharmaceutical company
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced
that it has put a temporary hold on all shipments of its fully liquid
pentavalent vaccine Quinvaxem(®) and its hepatitis B vaccine Hepavax-Gene(®) as
the sterile operation of its Shingal facility in Korea may have been compromised
during recent operations. The Shingal facility was already scheduled to be
vacated next year. The operations in our new Incheon facility are not affected.
Currently the situation is being investigated. As a precautionary measure,
Crucell has imposed a hold on all material currently held on stock. Crucell
expects to resume shipping before the end of November when results of the
investigation are expected to be available.
There are no concerns in terms of product safety in relation to the use of any
of the vaccines that have already been distributed. All products currently in
the market were manufactured in compliance with GMP regulations and have passed
all release tests, including, without exception, all sterility analyses.
Due to the investigation and current production stop of Quinvaxem(® )and
Hepavax-Gene(®) Crucell anticipates that in the period up to and including
January 2011 new shipments of Quinvaxem(® )and Hepavax-Gene(®) shall be
limited. As of February 2011 full availability is expected. Crucell is working
with its customers and stakeholders to ensure uninterrupted execution in-country
immunization programs.
As a result of the abovementioned, the financial outlook for 2010, given in
August, no longer holds. Crucell will inform the market as soon as more clarity
on the financial impact is obtained.
This manufacturing issue is not uncommon to the biologics industry and generally
resolved without lengthy operational disruptions. Pending the investigation
outcome, Crucell has suspended the manufacturing operations in the Shingal
site. Crucell is positive it shall be able to resolve the situation and
estimates it can resume manufacturing as early as November 2010.
Crucell remains confident in the safety and quality of Quinvaxem(®) and Hepavax-
Gene(® )and the contribution of these vaccines in protecting children against
five important infectious diseases.
About Crucell
Crucell N.V. (NYSE 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/or treat
infectious diseases. In 2009 alone, Crucell distributed more than 115 million
vaccine doses in more than 100 countries around the world, with the vast
majority of doses (97%) going to developing countries. Crucell is one of the
major suppliers of vaccines to UNICEF and the developing world. Crucell was the
first manufacturer to launch a fully-liquid pentavalent vaccine. Called
Quinvaxem(®), this innovative combination vaccine protects against five
important childhood diseases. Over 130 million doses have been sold since its
launch in 2006 in more than 50 GAVI countries. With this innovation, Crucell has
become a major partner in protecting children in developing countries. Other
products in Crucell's core portfolio include a vaccine against hepatitis B and a
virosome-adjuvanted vaccine against influenza. Crucell also markets travel
vaccines, such as an 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 Johnson & Johnson, DSM Biologics, sanofi-aventis, Novartis,
Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the
Netherlands, with offices in China, Indonesia, Italy, Korea, Malaysia, Spain,
Sweden, Switzerland, UK, the USA and Vietnam. The Company employs over 1300
people. For more information, please visit www.crucell.com.
Forward-looking statements
This press release contains forward-looking statements that involve inherent
risks and uncertainties. We have identified a number of 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 US Securities and Exchange Commission
on April 7, 2010, in the section entitled 'Risk Factors'. The Company prepares
its financial statements under International Financial Reporting Standards
(IFRS).
For further information please contact:
?Oya Yavuz
Vice President Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
ir(at)crucell.com
www.crucell.com ?
[HUG#1456754]
PDF file:
http://hugin.info/132631/R/1456754/396593.pdf
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originality of the information contained therein.
Source: Crucell N.V. via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 28.10.2010 - 16:36 Uhr
Sprache: Deutsch
News-ID 47116
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Town:
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Kategorie:
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