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news.Merck & Co and Cardiome Pharma, a cardiovascular drug development company, have signed a collaboration and licensing agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation.
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The agreement provides Merck with exclusive global rights to the oral formulation of vernakalant (vernakalant (oral)) for the maintenance of normal heart rhythm in patients with atrial fibrillation, and provides a Merck affiliate, Merck Sharp & Dohme, with exclusive rights outside of the US, Canada and Mexico to the intravenous (IV) formulation of vernakalant (vernakalant (IV)) for rapid conversion of acute atrial fibrillation to normal heart rhythm.
Under terms of the agreement, Merck will pay Cardiome an initial fee of $60 million. In addition, 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 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 significant sales thresholds.
Cardiome has retained an option to co-promote vernakalant (oral) with Merck through a hospital-based sales force in the US. Merck will be responsible for all future costs associated with the development, manufacturing and commercialization of these candidates. Merck has granted Cardiome a secured, interest-bearing credit facility of up to $100 million that Cardiome may access in tranches over several years commencing in 2010.
The effectiveness of the collaboration agreement is subject to the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, if applicable, as well as other customary closing conditions. The agreement between Cardiome and Astellas Pharma US for vernakalant (IV) in the US, Canada and Mexico is unaffected by this agreement.
Luciano Rossetti, senior vice president and franchise head of atherosclerosis and cardiovascular at Merck Research Laboratories, said: “This agreement underscores Merck’s ongoing commitment to the R&D of new cardiovascular drugs. Vernakalant is an important addition to our broad portfolio of products and candidates that target multiple aspects of heart disease.”