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Re: DB9 post# 4447

Thursday, 08/02/2007 11:10:07 AM

Thursday, August 02, 2007 11:10:07 AM

Post# of 19309
I’m somewhat surprised by today’s CD20 announce-
ment because it takes guts to go head-to-head against
Genentech and BIIB, who are co-developing a second-
generation CD20 mAb called Ocrelizumab:

http://www.gene.com/gene/pipeline/status/immunology/anti-cd20/index.jsp

>>
Description

Ocrelizumab is a humanized monoclonal antibody directed against the CD20 surface antigen on human B-cells. Anti-CD20 antibodies work by binding to a particular protein (the CD20 antigen) on the surface of normal and malignant B-cells. From there, they recruit the body's natural defenses to attack and kill the marked B-cells.

Development Status

We are interested in evaluating Ocrelizumab in multiple immunological diseases. Three Phase III trials in rheumatoid arthritis have initiated. Phase III trials in lupus nephritis, systemic lupus erythematosus and relapsing remitting multiple sclerosis and a Phase II trial in ulcerative colitis are planned.

(Our collaborator Biogen Idec disagrees with certain of our development decisions under our 2003 collaboration agreement. We continue to pursue a resolution of our differences with Biogen Idec. The disputed issues were submitted to arbitration in San Francisco, California. Resolution of the arbitration could require that both parties agree to certain development decisions before moving forward with humanized anti-CD20 antibody clinical trials, and possibly clinical trials of other collaboration products, including Rituxan, in which case we may have to alter or cancel planned trials in order to obtain Biogen Idec's approval.)

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The CD20 mAb from LFB/GTC will presumably be cheaper to make and it may be more efficacious due to enhanced ADCC, but DNA and BIIB will have a big head start.

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