Recently, Biogen Idec (BIIB: 55.25 0.00 0.00%) and Genentech, Inc., a wholly-owned member of the Roche Group, received approval from the US Food and Drug Administration (FDA) for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated as well as treated CD20-positive chronic lymphocytic leukemia (CLL).
The approval was based on data from two phase III studies, CLL8 and REACH, which evaluated the safety and effectiveness of Rituxan. One study, conducted in previously untreated patients, showed that progression-free survival was 8 months longer for patients receiving Rituxan plus chemotherapy, compared to patients who received chemotherapy alone.
The second study, conducted in patients who had already received other treatments, showed that progression-free survival was five months longer for patients on Rituxan plus chemotherapy.
The approval should help expand the market for Rituxan, which is currently approved as a treatment for rheumatoid arthritis and non-Hodgkin’s lymphoma (NHL), a type of cancer.
According to the American Cancer Society, CLL is the most common form of adult leukemia, accounting for one-third of all leukemia cases in the United States. About 90,000 Americans are living with CLL and it is estimated that about 16,000 new cases are diagnosed every year.
Rituxan 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. Rituxan contributed $1.1 billion to Biogen’s top-line in 2009. To keep the solid growth up, both companies are working to expand Rituxan beyond its current use.
Apart from Rituxan, 2 other drugs that received approval for the treatment of CLL in the recent past are Cephalon’s (CEPH: 67.76 0.00 0.00%) Treanda and GlaxoSmithKline’s (GSK: 37.42 0.00 0.00%) Arzerra. Other currently approved treatments include Glaxo’s Leukeran and Bayer’s (BAYRY: 0.00 N/A N/A) 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 Biogen will continue to retain a leading position in the MS market
The approval was based on data from two phase III studies, CLL8 and REACH, which evaluated the safety and effectiveness of Rituxan. One study, conducted in previously untreated patients, showed that progression-free survival was 8 months longer for patients receiving Rituxan plus chemotherapy, compared to patients who received chemotherapy alone.
The second study, conducted in patients who had already received other treatments, showed that progression-free survival was five months longer for patients on Rituxan plus chemotherapy.
The approval should help expand the market for Rituxan, which is currently approved as a treatment for rheumatoid arthritis and non-Hodgkin’s lymphoma (NHL), a type of cancer.
According to the American Cancer Society, CLL is the most common form of adult leukemia, accounting for one-third of all leukemia cases in the United States. About 90,000 Americans are living with CLL and it is estimated that about 16,000 new cases are diagnosed every year.
Rituxan 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. Rituxan contributed $1.1 billion to Biogen’s top-line in 2009. To keep the solid growth up, both companies are working to expand Rituxan beyond its current use.
Apart from Rituxan, 2 other drugs that received approval for the treatment of CLL in the recent past are Cephalon’s (CEPH: 67.76 0.00 0.00%) Treanda and GlaxoSmithKline’s (GSK: 37.42 0.00 0.00%) Arzerra. Other currently approved treatments include Glaxo’s Leukeran and Bayer’s (BAYRY: 0.00 N/A N/A) 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 Biogen will continue to retain a leading position in the MS market
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