Merck acquires rights to atrial fibrillation candidate
pharmafile | April 16, 2009 | News story | Research and Development, Sales and Marketing | Merck, cv
Merck has signed an agreement with Vancouver-based Cardiome Pharma to develop its new treatment for atrial fibrillation vernakalant.
Merck will pay Cardiome an initial fee of $60 million, which could be followed by $200 million more in milestone payments.
Merck will have exclusive global marketing rights outside the US to the drugs oral formulation for the maintenance of normal heart rhythm in sufferers.
In a phase IIb trial in at-risk patients the 500 mg dose, vernakalant (oral) also reduced the rate of relapse compared with placebo.
The intravenous formulation, vernakalant (IV), is being evaluated for its ability to terminate an atrial fibrillation episode and return the heart to normal rhythm.
Merck Sharp & Dohme (Switzerland) will market this outside the US, Canada and Mexico.
Atrial fibrillation affects 2.5 million people in the US and 4.5 million in the EU and the market is set to become highly competitive.
Sanofi-Aventis' new treatment Multaq is in line for US marketing approval after an FDA committee recommended it last month and analysts forecast peak annual sales over $2 billion.
Atrial fibrillation is characterised by an erratic, often fast, heart rate which could lead blood clots, which in turn can cause heart attacks and strokes.
It is is the leading cause of hospitalisations for arrhythmia and can increase the risk of stroke, worsens the prognosis of patients with cardiovascular risk factors, and doubles mortality risk.
Cardiome's milestone payments include a maximum of $35 million to start a planned phase III programme for the oral formulation and submission for approval in Europe of the IV formulation
The company may also receive tiered royalty payments on sales of any approved products with the potential to receive up to $340 million.
Cardiome has retained an option to co-promote the oral formulation with Merck through a hospital-based sales force in the US.
Merck has given Cardiome a $100 million credit line for development costs which Cardiome will be able to access from next year.
"This agreement underscores Mercks ongoing commitment to the research and development of new cardiovascular drugs," said Luciano Rossetti, senior vice president at Merck Research Laboratories.
Cardiome's partner, Astellas Pharma US, has submitted a new drug application with the FDA for Kynapid (vernakalant hydrochloride) Injection.
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