First Milestone Achieved in Collaboration Agreement with Sanofi Pasteur
Leiden, The Netherlands, 31 March 2008 - Dutch biotechnology company Crucell N.V. today announced that its rabies monoclonal antibody combination has entered a Phase II clinical trial in the United States. At the beginning of the year, Crucell announced it had signed a collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies to be used in combination with sanofi pasteur rabies vaccine for post-exposure prophylaxis against this fatal disease. The start of the Phase II study constitutes the first milestone in this agreement.
The clinical trial will be a randomized, single-blind, controlled study in 140 healthy volunteers that will test the antibody product in association with sanofi pasteur rabies vaccine and compare it to the currently marketed human rabies immune globulin or placebo, in association with rabies vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.
"We are very pleased with our continued and rapid progress with this next generation rabies treatment," said Ronald Brus, Crucell's Chief Executive Officer. "The swift development of this rabies monoclonal antibody product would be extremely valuable in reducing the global burden of this fatal disease."
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.
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 this fatal disease have appeared. Rabies is prevented by post-exposure prophylaxis (PEP) with the combined administration of a rabies vaccine and rabies immunoglobulin (RIG). Rabies is prevalent in Europe, Asia, Africa, North America and South America. Every year approximately 10 million people are vaccinated against the disease worldwide. An estimated 40,000 to 70,000 people die from rabies each year, mainly in Asia.
About Crucell's rabies monoclonal antibody program
Crucell's rabies monoclonal antibody product is a combination of two human monoclonal antibodies, generated using Crucell's MAbstract® technology and produced using Crucell's PER.C6® technology. Crucell's rabies monoclonal antibody combination offers the potential to replace the traditional serum-derived products that are currently used for rabies post-exposure prophylaxis. Phase I clinical trials conducted in the United States and India demonstrated safety and the ability to protect. The antibody combination is well tolerated, provides the expected virus neutralizing activity and can be safely administered in association with a rabies vaccine. 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.
In December 2007, Crucell and sanofi pasteur signed an exclusive collaboration and commercialization agreement for Crucell's rabies monoclonal antibodies, next-generation rabies biologicals, to be used with sanofi pasteur 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 received an initial payment of €10 million following the execution of the agreement and will be eligible for milestone payments of up to €66.5 million.
Peak sales for Crucell's rabies antibody combination are expected to exceed US$ 300 million.
About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. The strengths of the PER.C6® technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
About MAbstract® technology
Crucell's proprietary MAbstract® technology can be used to discover drug targets, such as cancer markers or proteins from infectious agents including bacteria and viruses, and identify human antibodies against those drug targets.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
