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.
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.