• Crucell has developed a human monoclonal antibody cocktail in collaboration with the Thomas Jefferson University (TJU) in Philadelphia and the US Centers for Disease Control and Prevention (CDC) in Atlanta, using MAbstract^® and PER.C6^® technology.
• Multiple Phase I studies were carried out in the US in the fourth quarter of 2006 and in Asia in the first quarter of 2007.
• Crucell and sanofi pasteur signed an exclusive collaboration and commercialization agreement for the development of a rabies monoclonal antibody cocktail using Crucell's PER.C6^® manufacturing technology. This antibody cocktail is to be used with the rabies vaccine for post-exposure prophylaxis against this fatal disease.
• Due to promising Phase I results of a US and an Indian study completed in 2007, Crucell was notified by the FDA Department of Health and Human Services that its rabies monoclonal antibody cocktail has been granted a Fast Track designation. Under the terms of the agreement, Crucell will continue to perform the development activities. Crucell will be responsible for the manufacturing of the final product and will retain exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF.
• In December 2007, Crucell received a payment of €10 million following the execution of the agreement and will be eligible for milestone payments of up to €66.5 million.
• Crucell's rabies monoclonal antibody cocktail entered a Phase II clinical trial in the US in March 2008. On May 12 2008, the start of a second Phase II study in the Philippines was announced.

We are developing a human monoclonal antibody cocktail for the post-exposure treatment of rabies. The use of Crucell’s MAbstract^® technology resulted in a combination of two human anti-rabies antibodies. The monoclonal antibodies are produced on Crucell’s PER.C6^® technology.

There is no treatment for rabies once symptoms of the disease have appeared. Lethal rabies is prevented by post-exposure prophylaxis (PEP) via the combined administration of a rabies vaccine and rabies immune globulin (RIG) following the bite of a rabid animal. Neither vaccine nor RIG are effective independent of one another. Current supply and quality of rabies vaccine is sufficient, but RIG, derived from human or horse blood, is in short supply and carries certain safety risks. Crucell has conceived an antibody product that is produced using PER.C6^® technology, which offers large-scale manufacturing capabilities and production under serum-free culture conditions. Crucell's discovery offers the potential for an innovative and potent replacement for the outdated serum products that are currently still in use for the treatment of rabies.

In experiments conducted during 2004 in collaboration with TJU under a Collaborative Research and Development Agreement (CRADA) with the CDC, the antibody product demonstrated protection in the industry standard hamster model at least equivalent to human rabies immune globulin (HRIG).

Multiple Phase I studies have been carried out in the U.S. in the fourth quarter of 2006 and in Asia in the first quarter of 2007. Results of the Phase I study in the US was reported at the RITA "Rabies in the Americas" meeting held in Mexico on October 3, 2007. Results of the study indicated that the rabies antibody product was well tolerated, provided the expected neutralizing activity and could be administered in combination with rabies vaccine. Phase I trials in India, which started in April 2007, have also been completed. Data analysis is completed and results will be presented during the Joint International Tropical Medicine Meeting on November 30, 2007 in Bangkok, Thailand.

In November 2007, Crucell was notified by the FDA Department of Health and Human Services that its rabies monoclonal antibody cocktail has been granted a Fast Track designation.

Crucell has also contracted DSM Biologics, its alliance partner for the PER.C6^® technology platform, for the process validation and manufacturing of antibody batches for Phase III clinical efficacy studies.

Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal. The virus infects the central nervous system, causing encephalopathy (disease of the brain) and ultimately death if medical treatment is not sought before symptoms appear. Rabies is prevalent in all the continental regions of Europe, Asia, America and Africa. Globally, approximately 10 million people a year are treated after exposure to rabies. Some 40,000 to 70,000 people are thought to die of the disease each year, mainly in Africa, China and India.