Showing posts with label Vicriviroc Schering Phase III HIV drug candidate study FDA not approved October 27 2008 January 20 2010. Show all posts
Showing posts with label Vicriviroc Schering Phase III HIV drug candidate study FDA not approved October 27 2008 January 20 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.