Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced the results of a second phase II clinical study of its investigational rabies monoclonal antibody combination, which started in May 2008 in the Philippines.
Crucell has 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 association with a rabies vaccine for post-exposure prophylaxis against the fatal disease of rabies.
This phase II trial was set up as a randomized, single-blind, controlled study in 48 healthy children and adolescents in a high endemic area of Metro Manila, Philippines. The trial was set up to test the safety and tolerability of the antibody product in association with sanofi pasteur’s VerorabÂ® rabies vaccine in a direct comparison with the marketed human rabies immune globulin (HRIG) product. It was performed at the Research Institute for Tropical Medicine under the leadership of Dr Beatriz P. Quiambao. The antibody product in association with the rabies vaccine was administered to 16 adolescents as well as 16 children. Its safety and neutralizing activity was compared to HRIG associated with the same rabies vaccine in 8 adolescents and 8 children. The results of the Philippines study showed Crucell’s rabies monoclonal antibody combination was safe and well tolerated. Neutralizing activity levels were similar in the subjects administered with the antibody product or with HRIG and all study participants reached adequate immunity levels. This study in children further broadens the population in which Crucell’s rabies monoclonal antibody combination could potentially be used. Earlier trials in adult populations have already shown safety and neutralizing activity. Detailed results of this study will be presented at the XX Rabies in the Americas RITA conference in Quebec, Canada on 18-23 October 2009.
“Our children are at high risk of getting rabies. The results of this study bring closer the moment that all-in-need get an adequate treatment against rabies.” said Dr Beatriz P Quiambao, Chief Clinical Research Division and Head, Rabies Research Group, Research Institute for Tropical Medicine, Muntiinlupa, Philippines.
“We are very pleased with our continued and rapid progress with this next generation rabies treatment and these results help us towards our ambition of reducing the global burden of this deadly disease” said Ronald Brus, Crucell’s Chief Executive Officer.
On February 12th, 2008 Crucell announced that its rabies monoclonal antibody combination was granted Fast Track status by the US Food and Drug Administration (FDA).
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 MAbstractÂ® technology and produced using Crucell’s PER.C6Â® 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 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 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 â‚¬10 million following the execution of the agreement and will be eligible for milestone payments of up to â‚¬66.5 million.
Peak sales for Crucell’s rabies antibody combination are expected to exceed
$ 300 million.
About PER.C6Â® technology
Crucell’s PER.C6Â® 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.C6Â® technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
About MAbstractÂ® technology
Crucell’s proprietary MAbstractÂ® 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.
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell’s core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6Â® production technology. The Company licenses its PER.C6Â® technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The Company employs over 1000 people. For more information, please visit www.crucell.com.