Dutch biotechnology company Crucell N.V. today announced that its rabies monoclonal antibody combination product has entered a second phase II clinical study in the Philippines. On 31 March 2008 the company announced the start of a first phase II clinical study in the U.S.

At the beginning of the year, Crucell announced a collaboration and commercialization agreement with sanofi pasteur for Crucell's rabies monoclonal antibody combination product to be used in combination with rabies vaccines for post-exposure prophylaxis against this fatal disease. 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. The first phase II study, as announced in March 2008, marked an important milestone in the collaboration agreement.

The second phase II clinical trial will be a randomized, single-blind, controlled study in 48 healthy adolescents and children. The study will test the rabies monoclonal antibody combination product in association with sanofi pasteur's rabies vaccine and will compare it to the human rabies immune globulin, which is currently administered with the vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity. This clinical trial aims to generate safety data in children in Asia, complementing the safety data generated in adult volunteers during a phase I trial conducted in India. Jointly, the combined data allows a swift phase III clinical evaluation of the monoclonal antibody combination in individuals exposed to rabies in endemic areas like Asia.

"We are clearly on a fast track with the development of this new rabies treatment", said Ronald Brus, Crucell's Chief Executive Officer. "Our rabies antibody combination product is highly suitable to replace the currently used serum-based products. This antibody product can be produced in sufficient quantities to cover public and private sectors needs by the use of our PER.C6® technology. Expanded product availability would clearly help combat the supply restrictions of serum-based immune globulin products. The continued rapid development of our rabies antibody product in combination with sanofi pasteur's rabies vaccine can therefore considerably reduce 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.

Peak sales for Crucell's rabies monoclonal antibody combination product are expected to exceed US$ 300 million.

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 immune globulin (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. Rabies causes over 50,000 deaths each year, mainly in Asia and Africa.