Cardiome Pharma Corp. Receives Notice Of Compliance From Health Canada For Its BRINAVESS NDS
Published: Mar 15, 2017
NASDAQ: CRME TSX: COM
VANCOUVER, March 14, 2017 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced today that it received a Notice of Compliance for BRINAVESS® (vernakalant hydrochloride, IV) from Health Canada, which enables Cardiome to begin commercializing BRINAVESS® in Canada. BRINAVESS® is indicated for the rapid conversion of recent onset atrial fibrillation ("AF") to sinus rhythm for: non-surgery patients with AF 7 days; and post-cardiac surgery patients with duration of AF 3 days. BRINAVESS® is not recommended for conversion of atrial flutter to sinus rhythm.
"We are pleased and excited to have received the Notice of Compliance for BRINAVESS® from Health Canada," said William Hunter, MD, CEO and President of Cardiome. "This is a very proud moment for the company since BRINAVESS® was discovered in Canada by Canadian researchers who had the goal of making this drug available in their own backyard. We have built a pharmaceutical company focused on bringing compelling medicines to acute care physicians in hospitals around the world, and we can finally say that BRINAVESS® will be made available to Canadian hospitals to treat patients who suffer from acute onset atrial fibrillation. It has been a long road for us to get to this point but we are very gratified now that we are here."
Commenting on the Notice of Compliance for BRINAVESS®, Jonathan Mather, Director and Global Head of Regulatory Affairs of Cardiome said, "This is an exciting moment for Cardiome as the Canadian market was one of the few remaining major markets in the world where BRINAVESS® was not yet approved for sale. We are pleased that Health Canada believed, as we do, that BRINAVESS® provides an attractive alternative to the currently available treatment options of recent onset atrial fibrillation. Our commercial team expects to begin detailing BRINAVESS® to our hospital customers during the second quarter, positioning us for commercial sales beginning in the third quarter."
Atrial Fibrillation affects approximately 350,000 persons in Canada.1
Cardiome would also like to provide an update on ongoing vernakalant IV discussions with the U.S. Food and Drug Agency. A Type A meeting is now scheduled during April and Cardiome's management expects feedback from that meeting during its second quarter of 2017. Vernakalant IV has been on clinical hold in the United States since 2010.
- Heart and Stroke Foundation of Canada. http://www.heartandstroke.ca/heart/conditions/atrial-fibrillation
BRINAVESS® (vernakalant HCl) is an antiarrhythmic drug that acts preferentially in the atria by prolonging atrial refractoriness and slowing impulse conduction in a rate-dependent fashion. BRINAVESS® is approved for marketing in Europe, Canada, and several other countries worldwide. In Europe it is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: 1) for non-surgery patients: atrial fibrillation 7 days duration; and 2) for post-cardiac surgery patients: atrial fibrillation 3 days duration. Vernakalant IV is not approved for use in the United States.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of innovative therapies that will improve the quality of life and health of patients suffering from disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant IV), approved in Europe, Canada, and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner Amomed in select European markets. Cardiome has also licensed: XYDALBA (dalbavancin hydrochloride), a second generation, semi-synthetic lipoglycopeptide approved in the EU for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults for select European and Middle Eastern nations and Canada from Allergan; and TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for Canadian markets from SteadyMed Therapeutics.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
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SOURCE Cardiome Pharma Corp.