US drug giant Merck & Co (NYSE: MRK) has discontinued further development of the oral formulation of vernakalant, which is the subject of a licensing deal with Canada-based Cardiome Pharma (Nasdaq: CRME). Cardiome shares dropped $1.01 to $0.90 in morning trading on the Toronto Stock Exchange yesterday.
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. An intravenous version of the drug is already approved in Europe as Brinavess and was submitted to the US Food and Drug Administration under a filing by Cardiome and Japan’s Astellas in 2007.
"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 of Cardiome, adding: "However, we look forward to continuing to work with Merck on the worldwide development and commercialization of vernakalant IV."
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