Navigation Links
Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study
Date:12/17/2009

NASDAQ: CRME TSX: COM

VANCOUVER, Dec. 17 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that the recently-completed Phase 3 European Comparator Study (the AVRO study) evaluating vernakalant (iv) versus amiodarone for the acute conversion of atrial fibrillation met its primary endpoint.

The AVRO study achieved statistical significance in demonstrating the superiority of vernakalant (iv) over amiodarone in the conversion of atrial fibrillation to sinus rhythm within 90 minutes of the start of drug administration. Overall the data suggests that vernakalant (iv) was well-tolerated in the study population. There were no vernakalant-related deaths or cases of "Torsades de Pointes", a specific and well-characterized ventricular arrhythmia.

Cardiome expects that detailed results of this study will be presented at a scientific conference in 2010.

In April 2009, Cardiome and Merck & Co., Inc. 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 a Merck affiliate, Merck Sharp & Dohme Corp., with exclusive global rights to vernakalant (oral) for the maintenance of normal heart rhythm in patients with atrial fibrillation, and provides another 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. If approved by the European regulatory authorities, Merck has exclusive rights to commercialize vernakalant (iv) in the European Union.

About the AVRO study

The AVRO study, titled "A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation", enrolled a total of 254 patients with symptomatic atrial fibrillation of 3 to 48 hours duration. Subjects were randomized to receive vernakalant (iv) or amiodarone in a 1:1 ratio. Safety was assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.

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. Cardiome is traded on the NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.

Forward-Looking Statement Disclaimer

Certain statements in this press 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. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, 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.


'/>"/>
SOURCE Cardiome Pharma Corp.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cardiome to Release Third Quarter Results
2. Cardiome And Astellas Announce Initiation Of Patient Enrolment In ACT 5 Trial
3. Orexigen(R) Therapeutics Presents New Data Showing Weight Loss with Contrave Significantly Improves Important Markers of Cardiometabolic Risk
4. Cardiome Pharma Corp. Announces Final Results of Tender Offer
5. Cardiome Pharma Corp. Announces Commencement of US$27.5 Million Tender Offer
6. Cardiome Announces Upcoming Presentation Of Results Of Phase 2b Clinical Trial Of Vernakalant (Oral) At The European Society Of Cardiology Congress 2009
7. Cardiome Pharma Corp. Announces Tender Offer To Purchase Up To US$27.5 Million Of Its Common Shares
8. Atherotech Adds New Cardiometabolic Tests Amid Strong 2009 Growth
9. Cardiome to Hold Conference Call
10. Cardiome Announces Management Transition
11. Cardiome Achieves Milestone From Collaboration With Merck Co., Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... Dobbs Ferry, New York (PRWEB) , ... April 30, 2016 , ... ... and the Dobbs Ferry campus. The following programs will be expanding due to ... Resources Management (HRM). The expansion will begin this summer. , School ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... announces the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula for ... and mood optimization products to the store is just one more way Shamangelic ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... ... advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and MIRACLES") ... Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie Siegel, ...
(Date:4/29/2016)... St. Petersburg, Fla. (PRWEB) , ... April 29, ... ... All Children’s Hospital surgeon reveals that infants born with severe congenital diaphragmatic hernia ... 3,000 babies is born with congenital diaphragmatic hernia (CDH)—a condition where the diaphragm ...
(Date:4/29/2016)... ... 29, 2016 , ... World Patent Marketing , a ... invention which aids in proper muscle development. , "The Gym & Exercise Equipment ... of World Patent Marketing. "Globalization has threatened the future growth of the industry ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... NEW YORK , April 28, 2016  The ... reached 275 million dollars, according to Kalorama Information and ... includes typing, immunoassays and nucleic acid testing.  The healthcare ... had made progress in developing blood collection stations and ... was made in Kalorama Information,s report, Blood ...
(Date:4/28/2016)... -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ... the development of oral drug delivery systems, announced today that ... presented by Joseph Gunnar & Co. LLC, taking ... . Nadav Kidron , CEO of Oramed, will ... Presentation Details:   PIONEERS 2016, presented by ...
(Date:4/28/2016)... PUNE, India , April 28, 2016 /PRNewswire/ ... - Pipeline Review, H1 2016" is a report ... pipeline and helps strengthen R&D pipelines by identifying ... best-in-class products. Company Profiles discussed in ... Menarini Industrie Farmaceutiche Riunite Srl, AbbVie Inc., Abiogen ...
Breaking Medicine Technology: