Merck and Co has filed vernakalant, an investigational compound for the treatment of abnormal heart rhythms, in Europe.
The company noted that the European Medicines Agency has accepted its marketing authorisation application for the intravenous version of vernakalant for acute atrial fibrillation, the most common cardiac arrhythmia which could lead to stroke. An oral form of the drug is currently in Phase II.
Merck gained the rights to vernakalant in April from Cardiome Pharma Corp in a deal which could net the Canada–based drugmaker $600 million. Astellas Pharma has the North American rights to the IV formulation of the treatment but a fortnight ago, the US Food and Drug Administration told the Japanese firm that it needs to conduct an additional Phase III trial.
That trial is expected to begin enrolling by the end of 2009, with completion expected in the first half of 2011. Doug Janzen, Cardiome’s chief executive, said that “while the additional time and expense of conducting another trial is unfortunate, we believe that Astellas will ultimately be successful in gaining approval”.
Stefan Oschmann, president, Europe, Middle East, Africa and Canada, Merck Global Human Health, said that acute AF “represents a significant unmet medical need, particularly for older adults”. He added that the decision by the EMEA “represents an important milestone in our long history of developing novel therapeutics for cardiovascular disease.”
Meantime, Schering-Plough, which is in the process of merging with Merck also noted that the EMEA is reviewing marketing applications for an asthma treatment and an oral contraceptive.
The agency is looking at a fixed-dose combination of Asmanex (mometasone) and Foradil (formoterol) for the maintenance treatment of asthma in patients 12 years of age and older. The EMEA is also reviewing a combination of nomegestrol acetate and 17 beta-estradiol, an oral contraceptive licensed from Merck KGaA affiliate Theramex.
The asthma combo is currently under review by the FDA and is currently in Phase III as a treatment for chronic obstructive pulmonary disease. S-P expects to file nomegestrol acetate/17 beta-estradiol in the USA in 2010.
