It wasn't a momentous quarter for Canadian drug developer Cardiome Pharma (Nasdaq: CRME ) , which released its Q3 financial results yesterday, but this could represent the calm before the storm. Its whole pipeline of cardiovascular drugs will be receiving regulatory scrutiny and producing clinical trial data over the next couple of months.
Cardiome's lead drug, vernakalant, is an acute atrial fibrillation treatment designed to help restore normal heart rhythm in patients. In multiple phase 3 studies, it has produced solid efficacy data compared to placebo.
Investors should mark their calendars for Dec. 11 and 12. That's when an FDA advisory panel will review intravenous vernakalant. The briefing documents the FDA will release before the meeting will be the first glimpse we get of which way the agency is leaning on whether to approve the drug before the vernakalant Prescription Drug User Fee Act date on Jan. 19.
Also in this quarter, interim data on a phase 2b study of an oral version of vernakalant will be released. Final data on it is expected in the first half of next year. The market for the oral version of the drug is bigger than for the intravenous version because it can be used as a prophylactic to prevent an acute episode of atrial fibrillation. The intravenous version is used only after symptoms occur. But data from the phase 2a study hasn't been as positive as data for the intravenous form of vernakalant.
If the intravenous version is approved in the U.S. in January, Cardiome will join a select group of small specialty pharmas, like The Medicines Company (Nasdaq: MDCO ) and CV Therapeutics (Nasdaq: CVTX ) , with cardiovascular medications on the market. Cardiome's North America marketing partner Astellas plans to launch the drug immediately in the first quarter if the FDA gives it the green light.
Watch for plenty of volatility in shares of Cardiome over the next couple of months. Depending on the way the regulatory and clinical trial data flies, this is the sort of stuff that can create opportunities, either long or short, in shares of drug developers, so investors should follow Cardiome's upcoming news closely.