Tuesday, May 11, 2010

Some LiveBlogging, Tomorrow -- Of New Merck's "Roadshow": Expectations Decidely Modest


Most analysts polled have some version of this to say, about the live R&D Day webcast Merck will conduct tomorrow morning, starting at 8:30 a.m. EDT:

. . . .expectations are fairly low, here -- not much real news is expected from the conference. . . .

Just the same, I'll listen in, and live-blog at least some of it -- on the off chance that some important development is disclosed. [Merck will essentially re-do the presentation, in an abridged fashion, on Thursday, at a Banc of America health care investors' conference.] Hey -- wait! -- wasn't it B of A that came out to defend Merck's stock on the day that Goldman Sachs downgraded it? Right. It was.

In any event, see below, tomorrow UPDATED -- 05.11.10 LIVE, now:


▲ Bridion (suggamadex) won't be resubmitted to FDA for approval in 2010 -- now it will be in 2011. Another delay for suggamadex; not a huge surprise -- after the non-approval in the summer of 2008.

▲ The MK 2578 (peglyated erythropoietin) candidate program has been discontinued due to regulatory feedback that cardiovascular risk studies would be required.

▲ Tredaptive is back -- planning US FDA filing in 2012 (this is the one Carrie Cox, in Spring 2008, predicted was only 60 days away from approval -- but the FDA rejected it!), because the required 25,000 patients have been enrolled in the FDA re-submission study. Yawn.

Like I said, not much terribly new and exciting (on the upside), here. UPDATE -- this will be a problem [Click to enlarge]:



3 comments:

Anonymous said...

'low' expectations is a good thing I suppose. I'm sure there is pressure on the Execs to hit it out of the park, which may require disclosure of novel morsels of data.

We'll see tomorrow.

What are your thoughts on the Zetia patent settlement? I think it was a good move to make it a non-issue (in light of rapid patent erosion plaguing the industry)

Hope you are well.

GhettoS

Condor said...

Hey, GS --

I think -- from my unaided memories, here -- that the core Zetia patent(when I first read it, about ten months ago) was not a particularly strong set of claims.

Thus, I confess, a 2016 date for Glenmark's entry looks more than passingly like "pay for delay", to my eye.

Whether the DoJ and FTC could mount a successful challenge to the deal is less clear -- but private parties and payors might.

Those suits rely on provisions of the Sherman and Clayton Acts. We'll see, but I'm not entirely convinced that this one deal won't come back to bite Whitehouse Station.

Thanks for checkin' in -- would appreciate your expert perspective of the strength of the patent claims. As you know, in large measure that will dictate whether the settlement is reasonable -- and thus largely immune from legal challenge.

Namaste

Anonymous said...

The ARB class is extremely safe and effective with very few side effects. Soon Diovan will go off patent as well as the five / six other branded players.

Novartis has sunk a ton of money into the next gen BP pill. But Wall Street doesn't seem too excited about it.

Is there a need in this economy for a new, slightly better more expensive high blood pressure pill?

I don't know.