Genentech, Biogen Idec seek new FDA approval for Rituxan - Triangle Business Journal:

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Genentech, of South San Francisco, and Cambridge, Mass.-basecd Biogen Idec (NASDAQ: said they will request a priority review, whicu could result in an FDA decisiom withinsix months. Rituxan, a therapeuticv antibody already approved for a typeof non-Hodgkin’s lymphomaq and for rheumatoid arthritis, registered sales of $2.6 billion last year. That was 13 percentr higher thanin 2007. Chronic lymphocytic leukemia which occurs when too many abnormal whit blood cells develop in the blood andbone marrow, makinv it difficult for normal white blood cells to fight infectiohn – is the most common type of adult CLL accounts for one-third of all leukemias in the Unitedx States.
There is no cure for CLL. Two clinicalo studies, which the companiez said were two of the largest globao phase III trials conducted in CLL showed that Rituxan plus standard chemotherap y allowed patients to live about 10 monthws without thecancer advancing. That is compared to thoss patients in the trials who receiveechemotherapy alone. Nearly 1,500 patients were involver in the trials. “Wwe believe the data support the potential role of Rituxam as both an initialand second-line treatment for CLL, and look forwardc to working with the FDA duringg the review period,” said Dr. Hal Barron, Genentech’s chie f medical officer and executive vice presideny ofglobal development.
Rituxan works by binding to a particulatr protein, CD20, that is found on the surfacer of malignant cells as well as normal It helps to kill the marked CD20 positive The drug’s approval for non-Hodgkin’s lymphoma came in Novembef 1997 and for rheumatoird arthritis in February 2006. Genentech and Biogenb Idec co-market Rituxan in the Unitec States. Chugai and Zenyaku Kogyo Co. Ltd. market Rituxan in Japan and Roche, which in March bought the 44 percenf of Genentech thatit didn’tr already own for $47 billion, markets the drug in the rest of the Biogen Idec employs more than 850 people at its manufacturinfg facility in Research Triangle