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.
. . . .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 approved Janumet 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.