Replies to post #48359 on Biotech Values

[DewDiligence]

Re: ASCO secrecy

How much can a company say in a PR and still
remain in ASCO’s good graces? This 2003 PR
from DNA is a reasonable template:

http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=6147

>>
Phase III Trial of Avastin Plus Chemotherapy Markedly Extends Survival of Metastatic Colorectal Cancer Patients

-- First Positive Phase III Results With an Anti-Angiogenic Therapy for Cancer --

-- Data to be Submitted to Upcoming ASCO Meeting --

South San Francisco, Calif. -- May 19, 2003 -- Genentech, Inc. (NYSE: DNA) today announced that a Phase III study of Avastin™ (bevacizumab, rhuMAb-VEGF) plus chemotherapy in previously-untreated metastatic colorectal cancer patients met its primary endpoint of improving overall survival. The magnitude of the benefit observed far exceeded what the study was designed to demonstrate. The trial also met the secondary endpoints of progression-free survival, response rate, and duration of response. Genentech plans to submit data from this Phase III metastatic colorectal cancer trial to the annual meeting of the American Society of Clinical Oncology (ASCO), May 31 - June 3.

…"This study also provides the first Phase III clinical validation of the long-pursued 'anti-angiogenic' hypothesis - that by targeting a tumor's blood supply, you may impact its viability. Based on the strength of these data, Genentech plans to discuss the filing of a Biologics License Application with the U.S. Food and Drug Administration," continued Dr. Hellmann.
<<

[poorgradstudent]

ASCO Embargo / Micro:

I think you'll generally agree with me that not all cases are the same. But unlike most other topics we discuss, I think almost all board members could agree on a case by case basis.

>But hardly any oncologists are going to prescribe - and no insurance will reimburse - Nexavar for liver cancer w/o so much as top line data to go on. So liver cancer patients were screwed for several months because Onyx and Bayer waited 4 months to report the results from that trial.<

Right. So I think this is a clear situation of the docs putting their silly abstract presentations first ahead of patient welfare. (Note from the trenches, abstracts don't mean crap... publications do)

Patients are better served by the data coming out ASAP. Companies are better served because it may mean quicker time to market (not necessarily, but *could*). I don't think the FDA cares one whit if the data they receive from a company has been presented at ASCO or not.

So really, it is either companies being whimps for fear of annoying ASCO, or the docs who cherish their precious ASCO abstracts.

In any case, I find it inexcusable to hide data that has the possibility of improving human health.

===

The only time when it really doesn't matter is when a company is trying an investigational drug in an add-on trial. So Taxotere + X versus Taxotere, for example. Since the drug isn't on the market, the bottleneck is the FDA process and not ASCO.

But for drugs available on the market, then the bottleneck is ASCO. They should be ashamed of themselves... and by "they" I mean the docs, because they comprise ASCO.

ok, i'm off my soapbox :-)