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.]

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