• Crucell is developing an epidemic (or seasonal) influenza vaccine in collaboration with sanofi pasteur, based on our proprietary PER.C6^® technology.
• PER.C6^® technology offers advantages in terms of safety and industrial-scale production.
• Phase I clinical trials for the epidemic flu vaccine in healthy adults began in the third quarter of 2006 and showed sound safety and tolerability data.
• Based on Phase I clinical study results of the seasonal influenza vaccine, Phase II testing of the cell culture-based seasonal influenza vaccine was initiated in the U.S. This project is part of a contract awarded in 2005 by the U.S. Department of Health and Human Services (HHS) aimed at accelerating the development of a new cell culture-based influenza vaccine. Phase II trials involving healthy adult volunteers in the U.S. will focus further on the safety profile and immunogenicity of the cell-based vaccine.

In alliance with sanofi pasteur (FluCell collaboration), we are developing an inactivated split virus influenza vaccine based on our PER.C6^® technology. PER.C6^® cells are highly susceptible to influenza viruses, thereby making the production of large amounts of influenza virus vaccine feasible. The epidemic vaccine will be a mix of 3 virus strains annually recommended by the World Health Organization (WHO).

Influenza vaccines are classically produced on embryonated chicken eggs. The safety and efficacy of such vaccines is proven, but various challenges have led the biopharmaceutical industry and the scientific community to explore other ways of producing influenza vaccines. PER.C6^® cells grow well in suspension and are easily scalable, potentially permitting the production of cost-efficient vaccines in large quantities. A key benefit of PER.C6^® cells is that they have a safety profile that is unequaled by any other cell used for the manufacturing of influenza vaccines, such as African Green Monkey (VERO) cells and Madin Darby Canine Kidney (MDCK) cells. PER.C6^® cells can produce all influenza strains that we have tested, both human strains and the avian strains that may present a pandemic threat.

In December 2003, we entered into a strategic agreement with sanofi pasteur to further develop and commercialize novel influenza vaccines using our PER.C6^® production technology. Sanofi pasteur has the worldwide rights to develop, manufacture and commercialize PER.C6^®-based influenza vaccines. Crucell has the commercialization rights for Japan, which represents 15% of the US$ 1.5 billion global influenza vaccine market.

Sanofi pasteur, with Crucell as a subcontractor, received a US$97 million contract from the U.S. Department of Health and Human Services (HHS) in April 2005 for clinical development of PER.C6^®-based influenza vaccine and other related activities. See the sanofi pasteur website.

Phase I clinical trials for the epidemic flu vaccine in healthy adults began in the third quarter of 2006 and showed sound safety and tolerability data. Phase II studies in healthy adults were initiated in the U.S. in November 2007. This project is part of the contract awarded in 2005 by the U.S. Department of Health and Human Services (HHS) aimed at accelerating the development of a new cell culture-based influenza vaccine. Phase II trials involving healthy adult volunteers in the U.S. will focus further on the safety profile and immunogenicity of the cell-based vaccine.

Yearly epidemic outbreaks of influenza cause high morbidity and mortality rates. During each influenza virus season, it is estimated that about 10 to 20% of humans worldwide contract the flu, and an average of 3 to 5 million people suffer severe illness. About 250,000 to 500,000 people die each year from complications associated with flu.

For Press Releases and Scientific Papers that relate specifically to our Influenza program, please refer to the Influenza Media Kit.