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Cardiome (COM.TO) Release: New Data Presented At European Society of Cardiology Congress 2017 Highlights Clinical Benefit Of BRINAVESS



8/30/2017 7:24:43 AM

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Results Support the Clinical Utility of BRINAVESS as a Treatment Alternative to Electrical Cardioversion in Patients with Recent Onset Atrial Fibrillation

Retrospective Analysis Suggests that Treatment with BRINAVESS Results in Lower Long-Term Relapse Rate at One-Year Relative to Electrical Cardioversion

NASDAQ: CRME TSX: COM

VANCOUVER, Aug. 30, 2017 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced the presentation of new data for BRINAVESS (vernakalant hydrochloride, IV), the Company's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), in a poster at the European Society of Cardiology Congress (ESC) 2017. The retrospective data analysis showed that administration of BRINAVESS led to faster restoration of sinus rhythm and shorter hospital stays when compared to the same results for electrical cardioversion (ECV). While ECV was more effective in the cardioversion of recent onset AF (94.0% vs. 66.5% respectively), longer-term there was statistically significant reduction in AF recurrence in patients treated with BRINAVESS relative to ECV after 365 days. The abstract, number P3632, is available on the ESC 2017 website.

"These data reinforce our conviction that BRINAVESS remains an important treatment alternative for patients, particularly for those who choose pharmacologic cardioversion over ECV and are not good candidates for sedation or anesthesia required with ECV, and when ECV may not be an optimal strategy. BRINAVESS is also a relevant therapeutic option in countries where treatment with ECV is still prevalent, as well as in treatment centers lacking necessary facilities where the physician may want to treat as quickly as possible," said Kiran Bhirangi, M.D., Cardiome's Head of Medical Affairs. "When used appropriately, BRINAVESS has the potential to improve patient outcomes with its ability to rapidly induce cardioversion, decrease time to discharge and reduce AF recurrence, and it remains a clinically proven option for physicians treating patients in the acute hospital setting."

Poster P3632, "Comparison of intravenous vernakalant and electrical cardioversion in recent-onset atrial fibrillation: Effect on time to restore sinus rhythm and length of hospital stay," is a retrospective study comparing BRINAVESS versus electrical cardioversion (ECV) in the cardioversion of recent onset AF to sinus rhythm after less than 48 hours. For the comparison, a total of 396 consecutive patients were reviewed, with 197 patients receiving BRINAVESS intravenously and 199 patients undergoing ECV. The primary endpoints were time from AF onset to initiation of treatment to restoration of sinus rhythm and length of hospital stay. Full study results are summarized below:


BRINAVESS

Electrical
Cardioversion

p value

Number of patients (n=396)

197

199


% successful cardioversion

66.5

94.0

<0.001

Time from admission to onset of cardioversion (hours)

3.1 ± 2.1

5.9 ± 3.9

<0.001

Time from AF onset to restoration of sinus rhythm (hours)

10.6 ± 6.8

17.4 ± 10.5

<0.001

% patients with restored sinus rhythm within 12 hours of AF onset

43.4

18.4

<0.001

Time to patient discharge (hours)

8.8 ± 5.3

13.7 ± 7.0

<0.001

% AF recurrence at 365-day follow-up

36.1

63.3

<0.001

 

About Atrial Fibrillation

Atrial Fibrillation (also known as AFib or AF) is a supraventricular tachyarrhythmia with uncoordinated atrial activation resulting in ineffective atrial contraction and if left untreated, structural and/or electrophysiological atrial tissue abnormalities.1 AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age.1 AF is associated with a 5-fold increased risk of stroke, 3-fold risk of heart failure, and 2-fold risk of dementia and mortality.1 One in five of all strokes is attributed to atrial fibrillation; these are often severe and result in long-term disability or death. Short duration AF episodes carry the same stroke risk as permanent AF, furthermore, undiagnosed 'silent AF' is a likely cause of some 'cryptogenic' strokes.2 Hospitalizations account for the majority of the cost burden associated with the treatment of AF.  There are two strategies to manage AF, namely, rhythm- or rate-control. A rhythm-control strategy may be used in patients who are severely compromised, remain symptomatic despite adequate rate control, when adequate rate control is difficult to achieve, when long term rhythm control therapy is preferred, younger patient age, presence of tachycardia-mediated cardiomyopathy, and first episode of AF.1,2 Early intervention with a rhythm-control strategy to prevent progression of AF may be beneficial to the AF patient.1

About BRINAVESS®

BRINAVESS (vernakalant HCl, IV) 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 countries for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban hydrochloride) 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 countries 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.

References

  1. January CT et al. 2014 AHA/ACC /HRS guideline for the management of patients with atrial fibrillation. J AM Coll Cardiol. 2014;34:e1-e76.
  2. Camm AJ et al. Guidelines for the management of atrial fibrillation, The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2369-2429.

Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2017 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing or future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities. These and other risks are described in the Form 40F and associated documents filed March 29, 2017 (see for example, "Risk Factors" in the Annual Information Form for the year ended December 31, 2016), in the Form 6-K filed August 10, 2017, and in our other filings with the Securities and Exchange Commission ("SEC") available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

SOURCE Cardiome Pharma Corp.


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