Sanofi Pasteur enters agreement eith Crucell for next-generation biologicals against rabies

Jan 4 2008

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has signed an exclusive collaboration and commercialization agreement with Crucell N.V. for Crucell's rabies monoclonal antibodies (MAbs), next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

Rabies causes 55,000 deaths worldwide annually, mostly in rural areas of Asia and Africa(1). Today there is no treatment for rabies once symptoms of the disease have appeared. Post exposure prophylaxis for severe bites requires both active immunization, using vaccines such as those currently marketed by sanofi pasteur, and passive immunization in the form of rabies immunoglobulins (RIG). Rabies monoclonal antibodies (MAbs) are expected to be an innovative and potent alternative to currently used RIGs.

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."

Crucell has developed a combination of two rabies MAbs that has shown favorable results comparable to current immunoglobulin products in preclinical trials. Phase I clinical trials demonstrated that the MAb-based 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.

Under the terms of the agreement, Crucell will continue to perform the development activities and will manufacture the final product. Crucell will receive a payment of EUR 10 million following the execution of the agreement and would be eligible for milestone payments of up to EUR 66.5 million.

Rabies is an acute viral encephalitis transmitted from animal to animal or from animal to human by exposure to saliva. Virus in saliva attaches to peripheral nerve endings and progresses to the brain. All mammalian species are believed to be susceptible. Dogs are a major reservoir of human rabies. They are responsible for most incidences of bites.

Rabies vaccination by Louis Pasteur was an important step in the history of vaccine when, in 1885, Joseph Meister, who had been bitten by a rabid dog, was successfully treated by successive inoculations during a 10-day period.