Merck and Cardiome have formed a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation (AF).
The companies said that the agreement provides Merck with exclusive global rights to the oral formulation of vernakalant for the maintenance of normal heart rhythm in patients with AF, and provides a Merck affiliate, Merck Sharp & Dohme, with exclusive rights outside of the U.S., Canada and Mexico to the intravenous (IV) formulation of vernakalant.
Under terms of the agreement, the Whitehouse, N.J.-based Merck said it will pay Cardiome an initial fee of $60 million. In addition, Vancouver, British Columbia-baaed Cardiome is eligible to receive up to $200 million in payments based on achievement of certain milestones associated with the development and approval of vernakalant products, including a total of $35 million for initiation of a planned Phase III program for vernakalant oral and submission for regulatory approval in Europe of vernakalant IV, and up to $100 million for milestones associated with approvals in other subsequent indications of both the intravenous and oral formulations.
Also, Cardiome will receive tiered royalty payments on sales of any approved products and has the potential to receive up to $340 million in milestone payments based on achievement of sales thresholds. Cardiome has retained an option to co-promote vernakalant oral with Merck through a hospital-based sales force in the Merck will be responsible for all future costs associated with the development, manufacturing and commercialization of these candidates. Merck has granted Cardiome an interest-bearing credit facility of up to $100 million that Cardiome may access in tranches over several years commencing in 2010.
In December 2007, the Cardiovascular and Renal Drugs Advisory Committee recommended that the FDA approve vernakalant IV for rapid conversion of AF. In August 2008, the FDA issued an approvable action letter requesting additional information.
Vernakalant oral is being evaluated as an oral maintenance therapy for the long-term prevention of atrial fibrillation recurrence. A Phase IIb double-blind, placebo-controlled, randomized, dose-ranging clinical trial in patients at risk of recurrent AF showed that at the 500 mg dose, vernakalant oral reduced the rate of AF relapse as compared to placebo.