As I first mentioned back in November 2010 (when Merck's stock took a one-day header on the NYSE, as extended release Kombiglyze® XR won FDA approval), Merck has been -- and is still -- playing catch-up here. [See my Janumet® XR FDA submission day post, for background, here.]
Yesterday's FDA approval -- for a once a day version of Janumet is good news for Whitehouse Station, but it is facing an entrenched competitor, with over a year and a quarter's lead in the market -- in Kombiglyze.
Here is a bit of the Boston.com piece -- do go read it all (H/t to Ed, at Pharmalot):
. . . .Drugmaker Merck & Co Inc. said Thursday it received U.S. approval for an extended-release version of its diabetes drug Janumet designed to be taken once a day, instead of twice a day.
The Food and Drug Administration approvedJanumet XR to help patients with type 2 diabetes control their blood sugar levels, in combination with diet and exercise, the company said in a statement. Janumet is a combination pill that includes sitagliptin, the primary ingredient in the company’s drug Januvia, with an older diabetes drug, metformin. . . .
Again, mildly nice news -- just nothing that could possibly move the needle.
Specifically, absent some very big upside surprise, Merck's early 2012 outlook, offered on the earnings call Thursday morning all but conceded that 2012 would be a flat (dead money) year for the world's No. 4 drugmaker. [Oh. Yes. As of year end 2011, Merck lost the No. 2 spot, as Roche lept past Pfizer, to take No. 1, and Pfizer slid to No. 2 -- based on latest-projected competitor global revenue figures.]
So it goes.
1 comment:
I think that you should view the race a little differently. The Januvia Franchise is clearly outpacing the competition. To focus solely on the XR race is off target because XR use is relatively small.
BTW, XR was always going to be an advantage for BMS because they had the product in-house. If they didn't win this race, then their Onglyza franchise would have been worse off than they are now.
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