Cardiome Provides Update on Merck's Development Plans for Vernakalant Oral
Cardiome Pharma Corp. (Nasdaq: CRME) today announced that Merck, known as MSD outside the United States and Canada, has communicated to Cardiome their decision to discontinue further development of the oral formulation of vernakalant. The decision was based on Merck's assessment of the regulatory environment and projected development timeline. Vernakalant oral was being evaluated as maintenance therapy for the long term prevention of atrial fibrillation recurrence.
"It is our understanding that vernakalant oral has continued to have a safe and effective profile as demonstrated by studies conducted since the product was licensed to Merck. We are extremely disappointed with the decision Merck has made" said Doug Janzen, President and Chief Executive Officer at Cardiome. "However, we look forward to continuing to work with Merck on the worldwide development and commercialization of vernakalant IV."
Merck will continue to support the intravenous formulation of vernakalant, which is marketed in the European Union and Latin America under the trade name BRINAVESSTM. Currently, BRINAVESSTM is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults in 37 countries. Merck has plans to expand the commercialization of the product throughout this year into new markets, and anticipates launching the product in approximately 30 additional countries in 2012.
In response to the discontinuation of the vernakalant oral program, Cardiome will reduce its annual operating cash burn going forward to a target of approximately $11M before interest expense, roughly half of the current cash burn. The company ended 2011 with over $53M of cash and cash equivalents and received an additional $25M from the available line of credit from Merck in January 2012. Cardiome expects to release its 2011 year-end financial results on March 28th, 2012 which will allow time to make the necessary changes to its annual filings following this news.
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