Cipher Pharmaceuticals Announces Canadian Launch of Brinavess® (vernakalant hydrochloride)

Wednesday, October 24, 2018 Heart Disease News
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MISSISSAUGA, ON, Oct. 24, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today  announced the Canadian launch of Brinavess®

(vernakalant hydrochloride) for the rapid conversion of recent onset atrial fibrillation ("AF"), (an irregular and often rapid heart rate that can increase your risk of stroke, heart failure and other heart-related complications) to sinus rhythm ("SR")
(a normal heart beat) for non-surgery patients with duration of AF less than seven days and post-cardiac surgery patients with duration of AF less than three days. AF affects approximately 350,000 patients in Canada.1

"Brinavess offers an important safe and effective option for the treatment of recent onset atrial fibrillation," states Dr. Paul Dorian, Department Director, Division of Cardiology, University of Toronto and Staff Cardiac Electrophysiologist at St. Michael's Hospital in Toronto.  "In Phase III trials, Brinavess demonstrated a median time to cardioversion of 11 minutes in 51% of the treated AF patients and 97% of these treated patients maintained SR at 24 hours post treatment."

In post-cardiac surgery settings, 47% patients cardioverted at a median time of 12 minutes when treated with Brinavess vs 14% patients in the placebo group (p<0.0001). 

In a head-to-head comparison study, treatment with Brinavess converted approximately 51% of treated patients to sinus rhythm, versus 5.2% of patients treated with amiodarone, resulting in a significantly higher conversion rate for Brinavess vs amiodarone treated patients at the 90 minute timepoint (p<0.0001).

"We are excited to bring this safe and effective treatment to Canadians who are suffering from acute onset atrial fibrillation," said Robert Tessarolo, President and CEO of Cipher. "Brinavess has demonstrated fast and sustained cardioversion to sinus rhythm which has been shown to reduce the length of stay in the emergency department which is critical for patient care in an acute hospital setting. Brinavess is Cipher's second product launch this year and seventh marketed product in Canada. We are committed to further expanding our Canadian business with future product launches and by continuing to assemble a broad portfolio of prescription products that serve unmet medical needs."

Cipher acquired Brinavess through the acquisition of the Canadian business portfolio of Cardiome Pharma Corp., which was completed in May 2018.

About Atrial Fibrillation

Atrial Fibrillation ("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.2 AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age. 2 Patients with AF may present with a variety of symptoms including palpitations, chest pain, shortness of breath, fatigue and light headedness. These symptoms alone can have a considerable impact on the patient's quality of life. 3 Individuals with AF have a 3 to 5 times greater risk for ischemic stroke and are also at risk for congestive heart failure. 4

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.

References:

  1. Heart and Stroke Foundation of Canada. http://www.heartandstroke.ca/heart/conditions/atrial-fibrillation. 
  2. 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.
  3. Benjamin EJ. et al.  Independent risk factors for atrial fibrillation in a population based cohort.  The Framingham Heart Study.  JAMA 271, 840-844 (1994).
  4. Lubitz SA. Et al., Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community.  J. Am Heart Assoc 2, e000126 (2013).

About Cipher Pharmaceuticals Inc.

Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. Cipher is focused on a three-pronged growth strategy – including acquisitions, in-licensing, and selective investments in drug development – to assemble a broad portfolio of prescription products that serve unmet medical needs. For more information, visit www.cipherpharma.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of certain securities laws, including the "safe harbour" provisions of the Securities Act (Ontario) and other provincial securities law in Canada and U.S. securities laws. These forward-looking statements include, among others, statements with respect to our objectives, goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions and statements relating to Cipher's acquisition of Cardiome Pharma Corp. ("Cardiome") pursuant to which the Company acquired the Canadian business portfolio of Cardiome, including statements in respect of the anticipated strategic and/or financial benefits of the acquisition and the anticipated regulatory approvals of products and the timing thereof. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements.

By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, our ability to enter into in-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; the product approval process is highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive; requirements for additional capital to fund future operations; dependence on key managerial personnel and external collaborators; no assurance that we will receive regulatory approvals in the U.S., Canada or any other jurisdictions; current uncertainty surrounding health care regulation in the United States; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; limited reimbursement for products by government authorities and third-party payor policies; various laws pertaining to health care fraud and abuse; reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the industry in which it operates; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; inability to meet covenants under our long term debt arrangement; compliance with privacy and security regulation; our policies regarding returns, allowances and chargebacks may reduce revenues; certain current and future regulations could restrict our activities; additional regulatory burden and controls over financial reporting; reliance on third parties to perform certain services; general commercial litigation, class actions, other litigation claims and regulatory actions; the effects of our delisting from the NASDAQ Global Market (the "NASDAQ") and deregistration of our Common Shares under the U.S. Securities Exchange Act of 1934, as amended (the "U.S. Exchange Act"); the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States; certain adverse tax rules applicable to U.S. holders of our Common Shares if we are a passive foreign investment company for U.S. federal income tax purposes; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; litigation in the pharmaceutical industry concerning the manufacture and supply of novel and generic versions of existing drugs; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the actions of a significant shareholder; we do not currently intend to pay dividends; our operating results may fluctuate significantly; our debt obligations will have priority over the Common Shares in the event of a liquidation, dissolution or winding up; and risks associated with the arrangement with Cardiome, including, among others, the failure to satisfy closing conditions and the absence of material adverse changes or other events which may give the parties a basis on which to terminate the arrangement agreement.

We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our Annual Information Form and in our Management's Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2017, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.

SOURCE Cipher Pharmaceuticals Inc.



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