Wednesday, July 11, 2012

Truly Exciting News! Merck's Next Gen Osteoporosis Candidate -- Early NDA Filing With FDA

While there are still some safety flags that the study's safety monitoring board wants to see fleshed out -- with continuing data, the news tonight is good. Very good. It offers the real possibility of a replacement for the generics- (and to a lesser extent, lawsuits-) beleaguered Fosamax® franchise.

Whenever a trial is halted early for positive efficacy, there is good reason for optimism about the potential for a blockbuster product to emerge. This is one of those times.

Here is a bit of the Reuters updated reporting -- but Merck leapt up 3 percent after-hours on the NASDAQ tonight, on strong volume, too. Do go read all of the Reuters reporting:

. . . .A pivotal trial of Merck & Co's experimental osteoporosis drug odanacatib has shown that it reduces fracture risk, prompting outside monitors to recommend that the study be stopped early.

News that the novel drug was shown to be effective sent shares of Merck up more than 3 percent.

The company said it expects to take a number of months to wind up the trial, which began in 2007, but will continue with an extension trial to follow up on certain safety issues flagged by the Data Monitoring Committee.

Merck said it expects to submit regulatory applications for U.S., European and Japanese approval of odanacatib in the first half of next year. . . .

Whitehouse Station now has news to genuinely rejoice about -- something potentially material, in SEC-speak, to boot. Kudos to Mr. Frazier's entire team.

[It would be well to bear in mind, however, that Lilly's Forteo is progressing nicely, as well, though too.]


Anonymous said...

At the risk of sounding like a petulant child, the team you are giving kudos to "i.e. Frazier et al", also made the questionable business decision of closing the research site responsible for the discovery of Odenacatib (i.e. Merck Frosst), which coincidentally, also discovered the other Phase III asset "Laropiprant" you highlighted in an ealier post. That said, I must confess that I do enjoy reading your blog and your extremely fair coverage of this once admirable company.

Condor said...

I do hear you, Anon.

Merck Frosst was an R&D group with a stellar reputation. Then came the battle-axe-weilding MBAs. . . .


Condor said...

Well -- in a stunning reversal -- Merck just announced that it would need additional safety and efficacy data before it would submit an NDA to FDA on this candidate.

My full report is here, from the monring call.

That puts a mid-2013 submission to FDA out of reach. Merck now says the FDA submission will come in 2014.

It's costing Merck about $1.30 a share in NYSE price quotation, on double normal volumes, this afternoon. Ugh.