Merck & Co. will return global marketing and development rights for both the intravenous and oral versions of the heart rhythm disorder drug Vernakalant to Cardiome Pharma, formally ending a 2009 collaboration that ran aground earlier this year, the companies said.
The IV formulation of Vernakalant, marketed in some countries as Brinavess™, was approved in the European Union in 2010 for rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults: for nonsurgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less. Vernakalant IV is not approved for use in the U.S. or Canada.
Vernakalant works by selectively blocking multiple ion channels in the heart that are known to be active during episodes of atrial fibrillation.
“Cardiome looks forward to continued advancement of the launch of Brinavess IV worldwide and welcomes the opportunity to continue development of Vernakalant oral worldwide and Vernakalant IV in North America,” William Hunter, M.D., Cardiome’s interim CEO, said in a statement.
The statement came six months after Merck told Cardiome it would end development of Vernakalant’s oral formulation, though not the IV version. Merck said March 19 it based its decision on an “assessment of the regulatory environment and projected development timeline.”
On July 9, Cardiome disclosed plans to lay off 85% of its staff, at a cost of $5 million in severance and other charges this year. The cutback occurred just days after CEO Doug Janzen resigned, and months after layoffs that nearly halved the company headcount to 54 people in March, from 92 at the end of 2011.
Cardiome and Merck entered into the partnership in April 2009. Merck agreed to pay Cardiome $60 million up front, as well as issue a $100 million line of credit as part of the agreement, through which Cardiome had hoped to earn an additional $640 million through success-based fees.
Cardiome borrowed $25 million under the credit facility in 2010, and another $25 million during the first quarter of this year. The 2010 advance must be repaid in full by Dec. 31, 2016; this year’s advance, by Dec. 31, 2017, the company said in its second-quarter results.
The Cardiome agreement gave Merck an exclusive global license to the oral formulation of Vernakalant for the maintenance of normal heart rhythm in patients with atrial fibrillation. Cardiome successfully completed a Phase IIb study evaluating this indication in July 2008. The deal also provided Merck’s Switzerland affiliate with exclusive rights outside North America to the IV formulation for rapid conversion of acute atrial fibrillation to normal heart rhythm.
At the time, the drug had completed Phase III development in the U.S., and was under FDA review. However, FDA told Cardiome and its previous North American partner, Astellas Pharma, that the agency needed to establish a better risk-benefit profile before granting final approval for the drug.