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jq1234

02/23/14 2:34 AM

#174657 RE: Rocky3 #174656

Of course, we won't know how much of the sales are in GTI in Q1 for awhile. Everyone had assumed that there were not enough GT2 and GT3 patients to produce the kind of sales that Sovaldi is doing, but we just won't know.



That's not accurate. GILD itself said majority patients were GT2 at JPM conference, but revised to say 70% were GT1 during earning call. If majority patients right now were GT2 as GILD said initially, I would bet GILD stock would be higher. 70% GT1 right now just takes away from future GT1 patients. That's my guess of what the market assumes at this point. Someone else might have done a survey and confirmed it.
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DewDiligence

02/23/14 12:10 PM

#174665 RE: Rocky3 #174656

Re: GILD’s HIV franchise

Huh? GILD's "colossal" HIV franchise is doing just fine right now…

Not sure why you put quotation marks around the word colossal insofar as GILD’s HIV franchise is selling at an annualized rate of $10B. However, in 2017 Viread will be off-patent in major jurisdictions and the longer-running patents covering Emtriva are weak.

Stribild and Complera are selling very well right now while there is no generic competition for any modern HIV regimen, but if TAF fails to show a clear clinical benefit vs Viread, third-party payers (including EU governments and the US’s Ryan White program) will opt for generic Atripla—or generic versions of the constituent drugs in Atripla—as the preferred cocktail for new patients.

So, for GILD investors there is indeed a lot riding on the ability of TAF to show a medically meaningful advantage relative to Viread.
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bladerunner1717

02/24/14 6:55 PM

#174723 RE: Rocky3 #174656

BMY get "breakthrough" designation for Hep-C combo

http://www.fiercebiotech.com/story/bristol-myers-picks-another-breakthrough-trophy-hep-c-cocktail-showdown/2014-02-24?utm_medium=nl&utm_source=internal

Today's Top News
1. Bristol-Myers picks up another 'breakthrough' trophy in hep C cocktail showdown
By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn


Bristol-Myers Squibb has picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's ($GILD) pioneering approach.
The FDA tapped a combination of daclatasvir (an NS5A replication inhibitor) and asunaprevir (their NS3 protease inhibitor) for genotype 1b patients. Last spring their triple drug cocktail, which also includes BMS-791325, an NS5B non-nucleoside polymerase inhibitor, was tapped as a breakthrough for genotype 1 patients.
Bristol-Myers ($BMY) has been hustling along with its various combos as Gilead pushes Sovaldi into the marketplace at a pricey $84,000 for a 12-week treatment course. Gilead already has its sights set on a filing for a combination of its own--Sovaldi and ledipasvir--which would further crack open the multibillion-dollar market waiting for interferon-free hep C drugs. And AbbVie ($ABBV) has been hurrying along with its own combination cocktail for the disease. All these efforts have posted some solidly promising efficacy results in key studies.
Payers have been paying particularly close attention to this late-stage cocktail race as physicians warehouse various patient groups—divided by genotype--for the right therapy. Interferon injections frequently have a cruel and intolerable impact on patients, leaving the field wide open to new combination therapies with a high likelihood of success in quelling the virus. The pioneers are being priced high, and payers would like to see some competition start to bring prices down quickly.
A second breakthrough designation for BMS at this stage may not sound like much at first glance, but any advantage on the regulatory front could pay back handsomely with an earlier entry into the market. Sovaldi earned $139 million in the first three weeks it was on the market at the end of December. That left analysts projecting sales of $5 billion to $6 billion in 2014, which would make it one of the most successful new drug launches in industry history.


Bladerunner