Crucell Puts Temporary Hold on Shipments of Quinvaxem and Hepavax-Gene
Thursday, October 28, 2021 10:37 AM

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Oct. 28, 2010 (Thomson Reuters ONE) --

Leiden, the Netherlands (October 28, 2021) - Dutch biopharmaceutical company Crucell (NASDAQ:CRXL) 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@crucell.com
www.crucell.com 

HUG#1456754


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This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.

Source: Crucell N.V. via Thomson Reuters ONE


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