After FiercePharma reported a scare in back in October, from an unexpected case of cardiogenic shock -- Merck seems ready to move to the next step on an oral formulation, and begin clinical trials on Cardiome's Vernakalant (MK 6621). In North America, Astellas has the rights to the IV formulation of the candidate, while outside the US, Merck has those rights (and will have the rights to any oral formulation, should that version reach market). Merck has one EU approval already in hand -- on the IV version, called Brinavess®.
From tonight's InVivo Blog, then -- do go read it all:
. . . .Vernakalant, which would be used as maintenance therapy to prevent recurrence of AF in people with a history of the condition, is important for Merck, but it's crucial to Cardiome. The Canadians have no other notable mid-to-late-stage assets in their pipeline except for the IV formulation, which this summer received EU marketing authorization under the brand name Brinavess. In the US, where it is in Phase III trials, Astellas Pharma has development and commercial rights.
Janzen said in August that Merck was being "very, very thorough," "thoughtful," and "big" -- a reasonable proposition, he said, given the $250 million estimated price tag of a late-stage global cardiovascular program and the number of internal committee reviews a behemoth requires for even a modest change of course. After all, the asset had survived the gauntlet of Merck's internal review after its acquisition of Schering-Plough.
Now Cardiome says in a release that Merck has completed another review and "informed Cardiome of its next steps in clinical development for oral vernakalant." The release didn't elaborate on what those next steps will be, but Janzen has previously observed that Merck is looking only for a first-in-class, best-in-class compound, so its trials will have to demonstrate superior heart rhythm maintenance to Sanofi's Multaq, against which it will compete. "That is the question to ask and will likely be the basis of the clinical program," he said at a Piper Jaffray conference in New York in December. Whether that program would include an outcomes study or head-to-head clinical trials, isn't clear -- but that could be where the clinical program is headed. . . .
We'll keep you posted.