Cardiome Pharma reported positive interim clinical results from its 90-day Phase 2b study of vernakalant (oral), and its board of directors has engaged Merrill Lynch as its financial advisor.
Cardiome said it has received expressions of interest from global and regional pharmaceutical companies in pursuit of partnership opportunities for vernakalant, and its board has engaged Merrill Lynch as its financial advisor to assist in evaluating the partnership opportunities, as well as alternative strategies beyond partnerships to maximize shareholder value, including acquisitions, divestitures and the sale of all or part of the company.
However, in late January, the FDA delayed the new drug application decision for Kynapid (vernakalant hydrochloride), or vernakalant (iv), from Cardiome and its co-developer Astellas Pharma.
The current interim analysis showed statistically significant efficacy for the patient group receiving 500mg b.i.d. of vernakalant (oral) as compared to placebo, and the safety data from the interim analysis also suggests that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied during the dosing period under analysis, according to the Vancouver, Canada-based Cardiome.
The double-blind, placebo-controlled, randomized, dose-ranging study was designed to test safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral) more than 90 days of dosing in patients at risk of recurrent atrial fibrillation, the company said.
Cardiome said it initiated the Phase 2b in the first quarter of 2007, and the completed enrollment included a total of 735 patients randomized, of which approximately 590 patients are expected to enter the maintenance phase and be measured for efficacy.