Navigation Links
Cardiome Provides Regulatory Update
Date:10/9/2008


NASDAQ: CRME TSX: COM

VANCOUVER, Oct. 9 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has been informed by its co-development partner, Astellas Pharma US, Inc., that an End of Review meeting with the U.S. Food & Drug Administration (FDA) has been scheduled for November 14th, 2008 regarding the New Drug Application (NDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. At the conclusion of FDA's review of an application and the issuance of an action letter, FDA provides applicants with an opportunity to meet with agency reviewing officials to discuss what further steps need to be taken by the applicant before the application can be approved.

Cardiome has also been informed by Astellas that, in an effort to align the North American regulatory strategy, Astellas has elected to withdraw the New Drug Submission (NDS) for KYNAPID with the Therapeutic Products Directorate (TPD) of Health Canada, originally submitted in May 2007. Cardiome and Astellas intend to revisit the Canadian regulatory strategy following resolution of the FDA process.

"Since receiving the FDA Approvable Letter in August, Cardiome and Astellas have been working diligently to collate information and analyses relevant to the issues raised in the action letter, and this meeting is intended to provide us with clear guidance so that we can focus our efforts on providing a robust response and attain U.S. approval for KYNAPID," said Bob Rieder, Chief Executive Officer of Cardiome. "We look forward to working with the FDA with the goal of having KYNAPID available to appropriate patients as soon as possible."

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 http://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 http://www.sec.gov and the Canadian securities regulatory authorities at http://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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Cardiome To Release Second Quarter Results And Hold Conference Call
2. Cardiome Announces Preferred Share Financing
3. Cardiome Announces Positive Phase 2b Results For Oral Vernakalant
4. Cardiome To Hold Conference Call
5. Cardiome Reports First Quarter Results
6. Cardiome To Release 2008 First Quarter Results
7. Cardiome To Release 2007 Results
8. Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor
9. Cardiome And Astellas Announce Regulatory Update
10. Cardiome to Hold Investor Update Call
11. Cardiome Updates Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... ... February 13, 2016 , ... Good news ... first in the area to offer AngioPlex™ Optical Coherence Tomography (OCT) Angiography, imaging ... as macular degeneration, diabetic retinopathy, and other vascular conditions. , In just a ...
(Date:2/13/2016)... ... 2016 , ... Many individuals looking to lead a healthy lifestyle have decreased ... IsoPasta by Isolator Fitness has delved into this niche allowing those giving up their ... IsoPasta has 30 grams of protein and only 7 grams of carbohydrates per ...
(Date:2/13/2016)... , ... February 13, 2016 , ... ... of Nursing with an in-kind gift of a VeinViewer® Vision vein finder ... they learn how to start an IV and draw blood, combining technology with ...
(Date:2/12/2016)... ... ... According to an article published February 4th on mySA, robotically ... hernia repairs throughout the United States. Commenting on this article, Beverly Hills hernia repair ... has not only been expected, but it seems to be a natural result of ...
(Date:2/12/2016)... ... February 12, 2016 , ... The Lymphoma Research ... lymphoma research and serving the lymphoma community through a comprehensive series of education ... Florida’s philanthropic community at its 10th anniversary Fashion Luncheon on Monday, February 8, ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... PUNE , Maharashtra, February 12, 2016 /PRNewswire/ ... Market research report titled Chronic Inflammation Global ... and a snapshot of the global clinical trials ... the clinical trials by Region, Country (G7 & ... End point status and reviews top companies involved ...
(Date:2/11/2016)... LONDON , Feb. 11, 2016 The ... current and future adoption patterns on the usage of ... include the following: - Timeframe of liquid ... types—CTCs, ctDNA, cfDNA and Evs—by organization type - Sample ... sample types: blood, saliva, stool, serum, and so on. ...
(Date:2/11/2016)... Feb. 11, 2016 PRO-DEX, INC. (NasdaqCM: PDEX) today ... December 31, 2015. The Company also filed its Quarterly Report ... 2016 with the Securities and Exchange Commission today. ... 2015 --> --> Net ... $2.6 million, or 95%, to $5.4 million from $2.8 million ...
Breaking Medicine Technology: