Biotech investors love binary events that can move a drugmaker's share price dramatically. Those in search of the next big biotech blowup or success story need look no further than cardiovascular-drug focused Cardiome Pharma (Nasdaq: CRME ) .
Wednesday, Cardiome presented at the Bear Stearns health-care conference. Nothing new was announced, but Cardiome did give a good overview of where its lead drugs stand.
Cardiome's lead drug candidate, vernakalant, is designed to help restore normal heart rhythm for patients who develop atrial arrhythmia (abnormal heartbeat) after surgery, for example. After two successful phase 3 studies, Cardiome and partner Astellas Pharma submitted a New Drug Application to the FDA for an intravenous form of the drug.
The Prescription Drug User Fee Act (PDUFA) date for intravenous vernakalant has been pushed back to Jan. 19 at the FDA.
Cardiome also has an oral version of vernakalant in phase 2 testing. The market for this compound is much larger than the IV version, as Cardiome is testing it as a daily prophylaxis to treat patients over an extended period of time to prevent atrial fibrillation for those at high risk for an occurrence of the disorder.
Cardiome estimates the potential market for the oral version of vernakalant at $800 million to $3 billion annually, compared to around $500 million peak global sales opportunity for the IV formulation. It is looking to partner the drug outside of the U.S. to help defray some of the cost of running a large phase 3 study.
Like all development stage drugmakers, Cardiome proclaims confidence that it will get a deal done with one of the "more than a dozen" potential partners with which it is in discussions about oral vernakalant, but not until interim and final results of a phase 2b study are released in the fourth quarter of this year and the first quarter of next year. With so many important events coming in the next several months, there's going to be some wild times ahead for Cardiome.
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