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

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Genentech, of South San Francisco, and Cambridge, Mass.-based Biogehn Idec (NASDAQ: BIIB) said they will request a priorityg review, which could result in an FDA decisioj withinsix months. Rituxan, a therapeutic antibody already approvedx for a typeof non-Hodgkin’ds lymphoma and for rheumatoid arthritis, registered sales of $2.6 billionj last year. That was 13 percent higher thanin 2007. Chroni c lymphocytic leukemia – which occurs when too many abnorma l white blood cells develoo in the blood andbone marrow, making it difficult for norma white blood cells to fight infectionh – is the most common type of adult CLL accounts for one-third of all leukemias in the Unite d States.
There is no cure for CLL. Two clinical studies, whicj the companies said were two of the largestg global phase III trials conducted inCLL patients, showes that Rituxan plus standard chemotherapy allowed patients to live aboutr 10 months without the canced advancing. That is compared to those patientxs in the trials who receivedchemotherapuy alone. Nearly 1,500 patients were involved in the trials. “W believe the data support the potentia l role of Rituxan as both an initialoand second-line treatment for CLL, and look forward to workint with the FDA during the revies period,” said Dr.
Hal Barron, Genentech’s chiefr medical officer and executives vice president ofglobal development. Rituxan works by bindinb to a particular protein, CD20, that is founrd on the surface of malignant cells as well asnormal B-cells. It helps to kill the marked CD20positive B-cells. The drug’w approval for non-Hodgkin’s lymphoma came in Novembert 1997 and for rheumatoid arthritisw inFebruary 2006. Genentech and Biogen Idec co-market Rituxan in the United States. Chugai and Zenyakuy Kogyo Co. Ltd.
market Rituxan in Japah and Roche, which in March bought the 44 percenr of Genentech thatit didn’t already own for $47 markets the drug in the rest of the Biogen Idec employs more than 850 people at its manufacturingh facility in Research Triangle