To listen in to the live webcast from JP Morgan, go register, preferably before 6:15 Eastern, at the link.
I'll offer commentary, and real-time analysis, of the more salient parts of Schering's remarks -- likely including some real-time slide screen-captures. . . I honestly don't expect to hear much of a material update -- from what was offered on November 24, 2008 -- at Schering's own R&D Update Web-Cast (similarly live-blogged). We'll see.
Schering-Plough
at the J.P. Morgan
27th Annual Healthcare Conference
Monday, January 12, 2009
6:30 p.m. EST
▲ 6:53 PM EST -- One small difference -- Dr. Koestler just said that Schering has "recently" met with FDA on Bridion/Sugammadex (which received a non-approvable letter last summer), and has a "plan for a way forward" -- but he did not back off of the November 24 disclosures: that it may take most of the year (2009) to get close to resolving those FDA issues. No real good news, there.
So -- circa 7 PM EST -- Almost nothing new since November 24 -- here's what is the SAME -- in the presentation, from then:
▲ Three of Schering's major projects are now at least five years away from where CEO Hassan said they would be -- just two years ago, at an earlier version of this conference. Boceprevir in particular will not receive any "quick shortcuts" on FDA approval -- that conflicts with the claimed "fast-track" status, on the November 24 slides.
▲ Dr. Koestler just called Schering's boceprevir "best in class" -- I guess that "class" reference must assume Vertex's teleprevir has already-graduated, a full year and a half ahead of Schering's own boceprevir
▲ Now, a regurgitation of the boceprevir Hep C naive treatment data, to date. . . . [see slides from November 24, and this, for some balance -- note that Vertex's Teleprevir is WORKING in patients that have already failed treatment on Schering's existing cocktails, among others. The significance of this fact -- from a scientific point of view -- almost cannot be overstated.]
▲ Asenapine is off-its-time-track at FDA (as admitted on the Q3 earnings conference call), and like Sugammadex, Schering today provides no details about when we might expect a meeting with FDA, or an end-date letter. "We are working on it with FDA," is all Schering will say. Not helpful. At all.
▲ It is also now a consensus view that Bridion/Sugammadex will be "slowly adopted" in the Operating Suites across Europe (it is not approved in the US) -- it will need to displace, in Carrie Cox's own words, "very-well-entrenched generics" -- meaning it will have to compete on price, as well as efficacy.
▲ Now on to a "proof-of-concept" (read: decades away from market) study, for a far-in-the-future Schering Hep C drug candidate, to be cocktailed with existing protease inhibitors. Will these numbers hold up in larger patient populations, and will these patients remain free of dangerous side effects? We'll see -- check my second "as edited" slide -- directly below, in a moment:
▲ Interestingly, Schering admits, at about Slide 35 of the November 24, 2008 deck, that Vytorin/Zetia will lose US patent exclusivity in 2015, and in EU/Japan in 2017 or 2018 -- yet, we won't even know if it works (to reduce cardiac event risks) before late 2012 -- that is when IMPROVE-IT will, best case, be finished. Wow. That slide lasted about five seconds -- then was deep-sixed. . . .
That was underwhelming, indeed.
2 comments:
So SP is working on it with FDA.
Well today FDA released guidances that allows off-label promotion of drugs. As I recall this would allow even 'expert' opinions to be used as promotion. For example as based on memory this would allow position papers that antipsychotics should be used in children with ADHD to prevent the development of mania later in life or something to that effect. Even if evidence from other studies such as publications by Harvard's Biederman indicate that it would only be effective in hypermania.
Now it's common practice in the pharmaceutical industry to intentionally study drugs in such a way so as allow intentional overdosing in children. So if FDA officials were clearly trying to help get at least one particular drug by the reviewer by asking the reviewer to assess he inadequate pediatric studies on the last day of a review cycle while the reviewer was trying to meet deadlines and thus make a mistake and not catch problems and had also been trying to prevent the reviewer from discovering severe lethal toxicities that would result in numerous deaths especially with chronic use and overdosing. Then the reviewer might conclude that this would constitute a design to commit numerous assaults on children without any expectation of benefit and thus might meet the criteria of 18 USC 1111. And even if deaths had not yet occurred might still be a violation of 18 USC 1113.
Under such conditions the reviewer might feel compelled to contact Congress and the FBI and even to engage in other protected first amendment activities.
The draft guidance may be found at:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
Now it does allow reviews etc. and on face everything appears OK, but seriously who really trusts companies to market drugs ethically and follow the rules anymore.
What could FDA have been smoking when they let this one through. The only thing I can think of is greenbacks.
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