Wednesday, January 20, 2010

Legacy Schering-Plough HIV Candidate, Vicriviroc, Fails Trial; Pulled From Merck's FDA Squadron

Pfizer already has an FDA-approved drug on the market, using this same mechanism -- so it was never going to be a blockbuster. Still, it is a[nother] disappointment -- in a long line of boxcars, a freight train of them, actually -- courtesy of Schering-Plough. Studies will continue on Vicriviroc, or SCH 417690 as it was known in treatment-naive HIV patients, but no more chasing the already in-treatment crowd.

And once again -- adopting a legacy Schering-Plough poor-disclosure practice -- Merck made the announcement via Investor FAQs, not via a formal press release or SEC-filed Form 8-K (Per Reuters reporting):

. . . .In two Phase III studies in this patient population, vicriviroc did not meet the primary efficacy endpoint," the two-paragraph notice said. It said the failed trials enrolled a high percentage of patients who continued to take three or more other active HIV drugs, along with vicriviroc.

Merck said it will continue mid-stage studies of the drug among patients not previously treated for HIV.

Cowen and Co had expected vicriviroc to achieve annual sales of $75 million in 2012, growing to $150 million in 2015 -- modest sales for the second-biggest U.S. drugmaker.

Pfizer Inc's already approved Selzentry works by the same mechanism as vicriviroc. But its sales have been crimped by the need for patients to take a diagnostic test that assesses whether they have mutated strains of HIV that inhibit effectiveness of the class of drugs. . . .

The worst of this news -- for HIV positive patients -- is one fewer future option.


Anonymous said...

ow~that has gotta hurt.

So, what exactly did Merck get when it spent $41b?

Condor said...

And get this -- Fred Hassan had predicted the drug would file with FDA in early 2010 -- and would generate $500 million to $750 million in annual sales by 2013.

What a crock. Per Peter Loftus, in tonight's WSJ:

. . . .a Schering executive had predicted the company would file for regulatory approval of vicriviroc in 2009 or 2010, and that the drug would have peak annual sales of $500 million to $750 million.

Wall Street expectations for vicriviroc, however, have been more modest because a similar drug already on the market, Selzentry, has had unimpressive sales since its introduction in 2007. Pfizer Inc. (PFE) developed Selzentry and last year contributed it to a new HIV drug joint venture Pfizer formed with GlaxoSmithKline PLC (GSK). Selzentry had about $49 million in sales for 2008, according to Credit Suisse. . . .

Indeed -- what did CEO Clark actually buy?

Note also that, with the increase in MRK's stock price (post the March 9, 2009 announcement date, but pre the November 4, 2009 merger closing date), it ACTUALLY paid closer to $64 billion for SGP, all-in.

Condor said...

CEO Clark ought to take all of the lost sales out of Fred's various severance packages, and golden parachutes -- AHP, Pharmacia and now Schering-Plough -- there'd still be leftovers!


Anonymous said...

i wonder what impact this will have to the legacy people from S/P that worked on this as a project. With the pending layoffs--one would think that they may now be on the 'chopping block.'

Anonymous said...

It is interesting that the Victor-E2 study was terminated back in Oct09. So, me thinks, Merck probably knew this information before finalizing the merger.

Also of interest, there remains 'recruiting' studies that will still look at experienced HIV patients and Vicriviroc on the S/P listing of clintrials. Wonder how long they will remain?

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condor said...

Okay -- um, do so at your own (considerable) peril.

No more spam, please.