Replies to post #105564 on Biotech Values

[iwfal]

I now agree BMY got ZGEN on the cheap..

Bet good money that BMY didn't share this data with ZGEN shareholders when they reached agreement on price. So again making obvious the risk of large conventional shareholders when there is group-think (in this case the mindset that DAA-only treatment will almost certainly obsolete ifn).

[DewDiligence]

It’s a little early to be writing off all-oral HCV regimens, IMO. In patients who had a null response to SoC in the first-line setting—the group BMY tested in the abstract you posted—three DAA’s rather than two will likely be needed to prevent viral breakthrough/rebound. The obvious addition to a cocktail consisting of a PI and an NS5A is a nuke.

[DewDiligence]

Please see the second paragraph of #msg-55725066. Regards, Dew

[iwfal]

ZGEN's last hurrah! - The data from the ph 2a inf-l trial:

http://www.natap.org/2010/AASLD/AASLD_53.htm

Difficult to make too much of it because the numbers are so small - and there are weird artifacts like the lower doses have higher SAE rates. But in general the trends are right with the only exception being that at the highest tested dose IFN-L required several step downs in dosing related to ALT.

PS Perhaps I missed it, but I have never seen any substantial discussion of the items published at the Nov AASLD meeting:

http://www.natap.org/2010/AASLD/AASLD.htm

[DewDiligence]

BMY reports interim phase-2 data for all-oral regimen of BMS-790052 plus BMS-650032:

http://finance.yahoo.com/news/AllOral-Treatment-Regimen-of-bw-1182894066.html?x=0&.v=1

…treatment with a dual, all-oral direct-acting antiviral (DAA) regimen of the investigational NS5A replication complex inhibitor daclatasvir (BMS-790052) and the investigational NS3 protease inhibitor asunaprevir (BMS-650032) achieved undetectable viral load at 12 weeks post-treatment (SVR12) in 90% (n=9/10) of genotype 1b hepatitis C (HCV) patients who had previously not responded to peginterferon alfa and ribavirin (alfa/RBV). Serious adverse events occurred in two patients in this study, of which one led to treatment discontinuation.

This is a small phase-2 study in Japanese patients with genotype-1b; the clinicaltrials.gov listing is at http://clinicaltrials.gov/ct2/show/NCT01051414 .

BMS-790052, the NS5A inhibitor, is the drug that is being paired with VRUS’ PSI-7977 in an all-oral trial on which BMY and VRUS are collaborating (#msg-63589775, #msg-68669755).

The BMS-790052 and BMS-650032 combination was discussed at AASLD 2010 in #msg-55118600 and left something to be desired. Whether this combination can be resuscitated for genotype-1b patients or Japanese patients, specifically, is an open question.