Showing posts with label 2010. Show all posts
Showing posts with label 2010. Show all posts

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.