After months of waiting on edge -- dare we say with its heart all a-flutter? -- Vancouver-based Cardiome Pharma said Dec. 29 that its partner Merck & Co. has "confirmed its plans for development" of an oral formulation of Cardiome's atrial fibrillation compound vernakalant.
Merck's decision gives Cardiome a lifeline it wasn't sure it had. Merck was supposed to start Phase III clinical trials in summer 2010, but those plans were delayed because Merck "continue[d] to optimize the clinical plan," Cardiome CEO Doug Janzen told analysts in August. Investors took that vague explanation with the same skepticism that greets a sports team owner's assurance that a troubled coach's job is safe; Cardiome's stock price lost nearly half its value in the three months following Janzen's description. (A setback in its injectable vernakalant program in October didn't help, either.)
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 that "we [at Cardiome] look forward to working with them as they advance the vernakalant (oral) program to maximize its potential." 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.