Crucell's Rabies Antibody Cocktail Granted Fast Track Status
Crucell N.V. announced that it has been notified by the food and Drug Administration's (FDA) Department of Health and Human services that its rabies monoclonal antibody cocktail has been granted a Fast Track designation.
On 3 October 2007 Crucell presented the results of the first clinical evaluation of the rabies cocktail at the XVIII Rabies in the Americas RITA conference in Mexico. This first-in-man phase I study, which was conducted in the US and started in January 2007, indicates that the cocktail is well tolerated, that it provides the expected neutralizing activity and that it can be safely co-administered in combination with a standard rabies vaccine.
"We are very pleased to receive the Fast Track designation for our rabies antibody cocktail," said Dr. Jaap Goudsmit, Crucell's Chief Scientific Officer. "Given the unmet medical need in rabies we are committed to moving as fast as possible. This designation along with its allowance of frequent interaction with the FDA and possible priority review mechanisms clearly signal the importance of expanding rabies treatment availability. People deserve to be protected against rabies."
Crucell is developing the rabies antibody cocktail for the post-exposure prophylaxis of rabies. The antibody cocktail is a combination of two human monoclonal antibodies and it is produced with the use of Crucell's MAbstract® and PER.C6® technologies. Based on market needs, peak sales for Crucell's cocktail are expected to exceed $300 million.
A second phase I study with the aim to assess the safety and efficacy of the antibody cocktail started in India in April 2007. The results of this study will be presented on November 30, 2007 at the Joint International Tropical Medicine Meeting 2007 in Bangkok, Thailand.
Crucell already contracted DSM Biologics, its alliance partner for the PER.C6® technology platform, for the process validation and manufacturing of antibody batches for phase III clinical efficacy studies.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
