Merck cuts support for oral vernakalant due to 'regulatory environment'

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Merck has communicated to Cardiome Pharma its decision to discontinue further development of the oral formulation of vernakalant, which is being evaluated as maintenance therapy for the long-term prevention of atrial fibrillation recurrence. The decision was based on Merck's assessment of the "regulatory environment and projected development timeline."

"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 CEO at Vancouver, British Columbia-based Cardiome. "However, we look forward to continuing to work with Merck on the worldwide development and commercialization of vernakalant IV."

Merck. of Whitehouse Station, N.J., will continue to support the intravenous (IV) formulation of vernakalant, which is marketed in the European Union and Latin America under the name Brinavess. Currently, Brinavess is approved for the rapid conversion of recent onset AF to sinus rhythm in adults in 37 countries. Merck 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 said it will reduce its annual operating cash burn going forward to a target of approximately $11 million before interest expense, roughly half of the current cash burn. The company ended 2011 with more than $53 million of cash and cash equivalents and received an additional $25 million from the available line of credit from Merck in January 2012, according to Cardiome. The company expects to release its 2011 year-end financial results on March 28.

Cardiome is reviewing the impact of this event on its business strategy moving forward, and will report the results of that review when it is complete.

In April 2009, Cardiome and Merck announced a collaboration and license agreement for the development and commercialization of vernakalant. The agreement provides Merck Sharp and Dohme with exclusive global rights to vernakalant oral, and provides another Merck affiliate, Merck Sharp & Dohme in Switzerland, with exclusive rights outside of the U.S., Canada and Mexico to vernakalant IV. In 2011, Merck also acquired North American rights to vernakalant IV, becoming a global partner for the entire vernakalant franchise.