Thanks go to Ed, over at Pharmalot for reminding me about this non-event; webcast here. In just a few minutes, Schering-Plough will begin a four-and-a-half hour,
no some-questions-asked session on what's right with Schering's R&D pipeline and its prospects. But remember, Schering will allow no press (or analysts' call-in) Q & A -- and remember (they just took a few questions), Schering doesn't give guidance or make projections (they just made some "aspirational goals" disclosures).
In other words, as Ed channels Deutsche Bank analyst, Barbara Ryan: "expectations. . . . appear to be fairly low."
Thus, as a public service, I will listen and watch -- so you won't have to. If anything truly ground-breaking [up, or down] occurs, I'll live-blog it, below:
▲ 1:28 PM -- Schering is going through a "re-tooling" in Japan (but as below, Schering will likely not get it all done until the end of the above window -- or, even beyond the end of the wondow it announced in the above slide). CEO Fred Hassan has still has not addressed the Seamus Fernandez (Leerik-Swann) questions about approaching China more aggressively -- they are simply "looking" (aggressively!) -- but don't have very many shoes in the street there.
▲ Asked "Will the TRA studies be read-out before IMPROVE-IT results are read-out?", Dr. Rick Veltri said, and Koestler confirmed that, as event-driven trials, he hopes that both come close in time to one another. That means IMPROVE-IT is running quite a bit slower than promised, as well.
▲ Dr. Koestler just said that Pegintron will be studied in combination with boceprivir -- this suggests they are more worried about Vertex's teleprevir, than they are letting on, here. Schering is looking for lots of "alternative" or back-up data, should the FDA decide to approve Vertex's candidate first. Vertex is well-ahead.
▲ The "Non-interference" (drug formulary) policy looks like it could be open to repeal -- given the new to-be-named HHS Secretary, Daschle -- and a deeply-Democratic Congress. CEO Hassan is (perhaps vainly) hopeful that "drastic" action will not be taken against pharma. Fred takes comfort that the "financial crisis" and "oil imports" will be bigger "targets" than Schering's businesses. That is not a very-reassuring answer. He is admitting to being No. 3 on the Administration's hit list.
▲ Bob Bertonlini on foreign currencies' "headwinds" -- in answer to Jamie Rubin, at Goldman Sachs -- Schering WILL face significant currency headwinds, in Q4 2008, and well-beyond. Schering's Euro-denominated debt is an "economic" hedge. However, "economic" hedges do not dampen P&L swings -- that is, profitability will be negatively impacted this year -- and beyond. This argument tells us to ignore GAAP results, and focus primarily on "growth" not GAAP-sanctioned "profitable growth". That is thus a rather-patronizing answer, to a clearly-very-able-questioner.
UPDATE: I think Fred just tried to clean up his currency answer.
▲ Carrie Cax is blaming the slower enrollments of patients in Schering's boceprevir studies on doctors "holding their patients back" -- only some 18 percent of patients are entering experimental programs. Could it be that the doctors have lost confidence in Schering's ability ot know when to "step in" and help protect patients -- if any given trial starts to exhibit troubling safety signals?
▲ CEO Hassan is now telling a Boston analyst that Schering is concerned about FDA not being "politically-independent". Ouch. He hope the Obama Administration will be able to remedy this. [Could it be that Schering has hurt its FDA credibility-levels, with Vytorin's ENHANCE?]
As the above slide demonstrates, even a good IMPROVE-IT outcome will be short-lived.
▲ 12:55 PM -- Three 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 below slides.
▲ Carrie Cox also just admitted that Bridion/Sugammadex will be "slowly adopted" in the Operating Suites across Europe (it is not approved in the US) -- it will need to discplace, in her own owrds, "very-well-entrenched generics" -- meaning it will have to compete on price, as well as efficacy. That is a wholly-new disclosure.
▲Carrie Cox admitted that Schering's boceprevir FDA filing will likely be 2011 or 2012. Ouch -- that would mean it may be four or five years away from market.
▲ 12:35 PM -- Carrie Cox is offering her perspectives on the "commercial potential" for these investigational candidates. Yawn.
▲ Now Veltri is on to Thrombin candidates (pre-clincial, and early-clinical) -- far future candidates.
▲ This -- the below -- Veltri's LDL-C "lower is better analysis" -- is simply "junk" science. It is religion -- not deduction or induction -- his entire Vytorin/Zetia slide-deck is infected with superstition.
▲ Every one of Dr. Veltri's slides assumes [without any evidence] that "mechanism of action" for cholesterol reduction is irrelevant.
▲ Rick Veltri is hard-selling the mantra that "lower is better" -- and just flatly stated that it "does not matter" what the mechanism of action for lowering is. This is in direct conflict with the vast majority of the data available to date.
▲ Now, Dr. Enrico Veltri is trying to debunk the cancer data in SEAS -- he said that IMPROVE-IT researchers will now only follow-up on cancer, every six-months, in the patient-population. Q: Is that wise?
▲ From "The Sublime to The Ridiculous" Department: there will be a "next-generation" study -- called, hilariously, "Red Cabbage" -- started by Schering, in 2009 [Veltri hisssself named it!]:
▲ 11:45 AM -- Rick Veltri (Yes, THAT Enrico Veltri!) is up, now -- on cardiovascular products. Rick is hard-selling fear -- blaming "pillars of science" for "waiving the white flag" -- and giving up, on treating heart-disease. Ri-i-i-i-i-i-ight.
▲ 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:
[NOTE: Here is the Schering presser's spin, on the above.]
▲ 10:40 AM -- Schering has moved on -- to a regurgitation of the boceprevir Hep C naive treatment data, to date. . . . [see slide above, 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.]
▲ Specific scientific presentations now underway, for the very-long pipeline tail -- including a potential for using cancer anti-bodies as a form of vaccine -- most are still in animal models. This means they are at least a decade away from market, in almost all cases.
▲ Schering has just issued two press releases, the first about Asenapine, the other about treating Parkinson's here, and here.
▲ Now, a 15 minute break -- slide coming [from me, below].
▲ 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.
▲Interestingly, Schering admits, at about Slide 35, 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.
▲ Koestler calls 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. . . .
▲ Fred asks "Why be excited?" Indeed, Why?
▲ 8:32 am EST -- and not started yet -- not surprising. . . .