Published: 08:00 03.01.2008 GMT+1 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562
Crucell Enters Agreement with Sanofi Pasteur for Next-generation Biologicals against Rabies
Exclusive agreement for rabies monoclonal antibodies to fight fatal disease
Leiden, The Netherlands, 3 January 2008 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced that it has signed an exclusive collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies, the next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.
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. Crucell will receive a payment of € 10 million following the execution of the agreement, will be eligible for milestone payments of up to € 66.5 million and will receive an undisclosed percentage on sales of the final product by sanofi pasteur.
Crucell has developed a combination of two rabies monoclonal antibodies that has shown favorable results comparable to current immunoglobulin products. Phase I clinical trials demonstrated that the antibody product is well tolerated, provides the expected immediate passive neutralizing activity and that it can be safely administered in combination with a rabies vaccine without interfering with the vaccine's ability to induce an active immunity. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. Crucell expects to enter phase II clinical trials in the first half of 2008. Peak sales for Crucell's rabies antibody cocktail are expected to exceed US$ 300 million.
Sanofi pasteur is the worldwide market leader in providing biologicals for pre- and post-exposure prophylaxis against rabies. In the last 20 years, over 20 million people in 100 countries have been treated with sanofi pasteur's rabies products.
"Sanofi pasteur is the global leader in providing rabies vaccine and immunoglobulin, and the only international company to offer a full range of rabies biologicals. Adding a next generation rabies treatment to our well-established rabies product range will further position the company as a leading force to help prevent this fatal disease," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "Louis Pasteur's first human rabies immunization in 1885 was a founding milestone for modern vaccination and we are proud to build on his legacy with innovative treatments."
"We are pleased that sanofi pasteur selected our rabies antibodies to be used in combination with their rabies vaccine," said Ronald H.P. Brus, Crucell's Chief Executive Officer. "Today, millions of people are exposed to rabies and often no life-saving treatment is available for this fatal disease. This agreement further validates our PER.C6® production technology and our MAbstract® technology for generating monoclonal antibodies."
About rabies
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 encephalitis (inflammation of the brain) and ultimately death if medical intervention is not sought promptly after exposure. There is no proven 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 RIG (rabies immunoglobulin) following the bite of a rabid animal.
Rabies is prevalent in Europe, Asia, North and South America as well as Africa. Every year, approximately 10 million people are vaccinated worldwide. An estimated 40,000 to 70,000 people die of the disease each year, mainly in Asia.
About Crucell's rabies antibody cocktail program
Crucell develops the antibody cocktail using its PER.C6® technology, which offers large-scale manufacturing capabilities and production under serum-free culture conditions. Crucell's rabies monoclonal antibody cocktail offers the potential for replacing the traditional serum-derived products that are currently still used for the treatment of rabies.
Crucell's cocktail is a combination of two human monoclonal antibodies, generated with the use of Crucell's MAbstract® technology and produced with the use of Crucell's PER.C6® technology. Phase I clinical studies (conducted in the US and India) recently showed that the antibody cocktail can be safely co-administered with rabies vaccine in line with standard therapy and that it provides the expected immediate passive neutralizing activity. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. The Fast Track program facilitates the development and expedites the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. Peak sales for Crucell's rabies antibody cocktail are expected to exceed US$ 300 million.