Biogen Idec (
BIIB) and Genentech, Inc., a wholly-owned member of the
Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL).
Although the companies did not provide any details regarding the letter, they said that the agency has not asked them to submit any new data. Genentech and Biogen intend to work towards gaining final approval for the expanded indication and are planning to continue final label discussions with the FDA.
Rituxan is currently approved for the treatment of rheumatoid arthritis and non-Hodgkin’s lymphoma (NHL), a type of cancer. It contributes significantly to Biogen’s top line. Biogen receives a profit-split on U.S. sales of Rituxan from Genentech, plus a royalty on international sales and reimbursement on development work. In 2008, the company recognized $1,128 million (up 22%) in Rituxan revenues. To keep the solid growth up, both companies are working to expand Rituxan beyond its current use.
According to the American Cancer Society, CLL is the most common form of adult leukemia, accounting for one-third of all leukemia in the United States. About 90,000 Americans are living with CLL and it is estimated that more than 15,000 new cases will be diagnosed this year. Current treatments for CLL include
Cephalon’s
(CEPH) Treanda,
GlaxoSmithKline’s (
GSK)
Leukeran and Bayer’s (
BAYRY.PK) Campath.
We currently have a Neutral recommendation on Biogen. The company is the market leader in therapies for the treatment of multiple sclerosis (MS) and we believe that Biogen will continue to retain a leading position in the MS market
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