Cardiome Achieves Milestone From Collaboration With Merck & Co., Inc.
Cardiome Pharma Corp. recently announced that it has earned a US$15M milestone payment from its collaboration with Merck & Co., Inc., through an affiliate. The milestone was triggered by the submission, by Merck, of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) seeking marketing approval for vernakalant (iv) in the European Union.
"Merck has done an exemplary job in filing for European approval so quickly, and I would like to thank both the Cardiome and Merck teams who have worked hard to ensure the timeliness of this submission." said Bob Rieder, Chairman and Chief Executive Officer of Cardiome.
The MAA was received by EMEA and after validation of the submission the Committee for Human Medicinal Products (CHMP) will coordinate the review. The review will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union.
The Phase III European comparator trial currently in progress is expected to complete in 2009.
In April 2009, Merck and Cardiome announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation. The agreement provides Merck with exclusive global rights to vernakalant (oral) for the maintenance of normal heart rhythm in patients with atrial fibrillation, and provides a Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to vernakalant (iv) for rapid conversion of acute atrial fibrillation to normal heart rhythm. The agreement became effective in May 2009.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. For more information, please visit our web site at www.cardiome.com.
SOURCE: Cardiome Pharma Corp.