Leiden, The Netherlands (October 20, 2009) - Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced that detailed results of the Phase II Philippines study of its rabies monoclonal antibody combination (CL 184) were presented at the XX Rabies in the Americas (RITA) Conference in Quebec, Canada. The presentation was given by Dr Beatriz P. Quiambao (MD), Chief Clinical Research Division and Head, Rabies Research Group, Research Institute for Tropical Medicine, Muntinlupa, Philippines and is available on Crucell's website www.crucell.com.
In June 2009, Crucell announced the results of the Phase II Philippines study in healthy adolescents and children, which showed that the antibody combination was safe and well tolerated. Neutralizing activity levels in subjects given the antibody product were similar to those in subjects given human rabies immunoglobulin (HRIG), the current standard for inducing immediate, passive immunity. All study participants reached adequate immunity levels. This study in a paediatric population, performed at the Research Institute for Tropical Medicine under the leadership of Dr Quiambao, further broadens the potential patient population for Crucell's rabies monoclonal antibody combination.
"We are very pleased with the outcome of the Philippines Phase II study as our children are at high risk of getting rabies. The progress with this next generation rabies treatment brings us closer to the moment when all-in-need will get adequate treatment against rabies." said Dr Quiambao.
"We continue to push this program forward in order to bring a high quality rabies treatment to the market as soon as possible. Plans to start the third phase II clinical study are progressing well after recent approval received from the Drug Controller General of India." said Ronald Brus, CEO Crucell. "The market for Crucell's rabies monoclonal antibody combination is estimated to be significant with peak sales expected to exceed $300 million."
This third phase II study will be carried out at Lotus Laboratories in Bangalore, India and is planned to start within the next six months. The rationale for this study is to collect safety and neutralizing activity data of the CL184 antibody in combination with the vaccine in a simulated rabies post-exposure prophylaxis setting to be used in Phase III.
Crucell's monoclonal antibody combination against rabies is being developed in close collaboration with Sanofi Pasteur using Crucell's PER.C6® manufacturing technology. This antibody combination is designed to be used in combination with a rabies vaccine for post-exposure prophylaxis against this fatal disease.
In 2007 promising Phase I data showed no serious adverse effects and demonstrated the expected rabies neutralizing activity upon administration. Positive results of the Phase II US study were presented to rabies experts at the 19th annual RITA meeting in Atlanta on October 1, 2008.
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 55,000 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 data conducted in the United States and India supported further clinical development. The program has been granted a Fast Track designation by the US Food and Drug Administration's (FDA) Department of Health and Human Services in February 2008. 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 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.
