Press Release Source: Crucell N.V. On Thursday October 28, 2010, 10:51 am
LEIDEN, NETHERLANDS--(Marketwire - 10/28/10) - Dutch biopharmaceutical company Crucell N.V. (NASDAQ:CRXL - News) (Swiss:CRX - News) 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.