Replies to post #4447 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

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.)
<<

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.

[DewDiligence]

Biosimilar mAbs in Oncology Will Garner Big Sales

[These numbers are bullish for GTC’s CD20 (Rituxan FoB) program, but this PR is essentially an ad, so take it with a grain of salt.]

http://biz.yahoo.com/prnews/081014/netu012.html

›Tuesday October 14, 8:00 am ET

Opportunity for Biosimilars Varies Significantly by Therapeutic Area, According to a New Report from Decision Resources

WALTHAM, Mass., Oct. 14 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the rapid uptake of biosimilar monoclonal antibodies (MAbs) in oncology will drive robust sales of drugs within this class. The most notable near-term biosimilar targets for MAbs in oncology are Genentech/Roche's Herceptin and Rituxan/MabThera.

The new special report Biosimilars 2007-2017: Shifting Payer and Physician Opinion Increases the Hurdles to Uptake forecasts that sales of biosimilar Herceptin will approach blockbuster status in 2017 in Europe alone, and biosimilar Rituxan/MabThera will garner $940 million in sales by 2017 in the United States, France, Germany, Italy, Spain and the United Kingdom. Based on the success of branded Herceptin and Rituxan/MabThera, near-term opportunity exists for drug manufacturers investing in the development of biosimilar MAbs in oncology. The report finds that oncologists will be among the most aggressive users of biosimilar drugs, and the high turnover of oncology patients will accelerate growth and penetration within the relatively un-crowded biosimilar MAb market.

Although oncology will prove to be a robust market, the opportunity for biosimilars varies significantly by therapeutic area, according to the report. For example, owing to an increasingly cautious attitude among neurologists regarding safety and efficacy associated with the use of biosimilars in chronic diseases like multiple sclerosis, the expectations for biosimilar interferon-betas in neurology remain tempered [fortunately, GTC has no interest in the FoB market for ifn-beta]. Additionally, the emergence of novel multiple sclerosis therapies will constrain interferon-beta use over the long-term; prior to biosimilar entry, forecasted sales of interferon-betas in the United States and European Union will fall to $2.3 billion in 2017-a significant decline from their peak sales of more than $4.7 billion in 2010.

"Despite the success of biosimilars in some areas such as cancer treatment, the launches of biosimilar interferon-betas for neurology in Europe in 2010 and in the U.S. in 2014, will not generate significant uptake of these agents," said Nicole Westphal, Ph.D., analyst at Decision Resources. "Given the high cost of clinical development, the conservative prescribing habits of neurologists, and the declining use of interferon-betas by 2017, biosimilar developers may want to explore other classes of biologics in which to invest their research and development funds."

About the Report

Biosimilars 2007-2017: Shifting Payer and Physician Opinion Increases the Hurdles to Uptake covers 18 key biologic brands from seven biologic classes and includes surveys of 402 U.S. and European physicians and 40 MCO pharmacy directors.

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.‹