Merck and Cardiome announced today that Merck was returning to Cardiome all marketing and development rights for the atrial fibrillation (AF) drug vernakalant. An intravenous formulation of vernakalant is marketed in Europe as Brinavess. It has not been approved in the United States, though it received a positive recommendation from the FDA’s Cardiovascular and Renal Drugs Advisory Committee in 2007.
Earlier this year, as reported here, Merck announced that it was ending its involvement in the development of an oral formulation of vernakalant.
During a conference call, Dr. William Hunter, the interim CEO of Cardiome, expressed confidence that the company would go forward with vernakalant. He pointed out that “what constitutes an opportunity for Cardiome is probably very different than what constitutes one for a global corporation the size of Merck.” In a press release, Hunter stated: “Cardiome looks forward to continued advancement of the launch of BRINAVESS IV worldwide and welcomes the opportunity to continue development of vernakalant oral worldwide and vernakalant IV in North America.”
Here is the press release from Merck and Cardiome:
Merck Returns Global Marketing and Development Rights for Vernakalant to Cardiome
VANCOUVER, CANADA and WHITEHOUSE STATION, N.J., SEPTEMBER 26, 2012 — Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that Merck will return the global marketing and development rights for both the intravenous (IV) and oral formulations for vernakalant to Cardiome.
Vernakalant IV is marketed, in certain countries, under the brand name BRINAVESS.TM BRINAVESS was approved in the European Union on September 1, 2010 for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults: for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less. Vernakalant IV is not approved for use in the United States or Canada.
The companies said that they will work together to smoothly transition activities and ensure continued availability of the product to physicians and patients in countries where the medicine is approved.
“We have made a business decision to return the rights for Vernakalant to Cardiome,” said Michael Mendelsohn, M.D., senior vice president & head, atherosclerosis and cardiovascular research, Merck Research Laboratories. “We continue to support the safety and efficacy profile of vernakalant. We look forward to working with Cardiome to conduct a transition that has the best interests of patients and their physicians in mind. Merck remains committed to developing new drugs for cardiovascular diseases.”
“Cardiome looks forward to continued advancement of the launch of BRINAVESS IV worldwide and welcomes the opportunity to continue development of vernakalant oral worldwide and vernakalant IV in North America,” said Dr. William Hunter, Interim CEO of Cardiome. “We thank Merck for its contribution to the Vernakalant program and anticipate a smooth transition for the physicians and patients who rely on BRINAVESS.”
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BrinavessTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. Cardiome is traded on the NASDAQ Global Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site atwww.cardiome.com.
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