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   Biotech / MedicalCardiome -- CRME


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To: tuck who wrote (265)8/11/2008 10:18:37 AM
From: former_pgs
   of 285
 
>Prior to considering approval, FDA requires additional information associated with the risk of previously identified events experienced by a subset of patients during the clinical trials in order to assure an acceptable risk benefit profile compared to electrical cardioversion. FDA has also requested a safety update from ongoing or completed studies of vernakalant, regardless of indication, dosage form, or dose level.<

The safety updates are routine, but the fact that the request in the first sentence is expressly separate from the request in the second sentence makes me think they will need some new data.

On a related matter, I've heard rumblings that the FDA is considering pulling water off the market...

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To: tuck who wrote (265)8/11/2008 11:08:36 AM
From: idos
   of 285
 
I believe the "subset" refers to the severe congestive heart failure (CHF) patients group, in which some also had ventricular dysfunction.

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To: former_pgs who wrote (266)8/11/2008 2:10:26 PM
From: Ian@SI
   of 285
 
Geez, don't give them any more ideas just in case your speculation isn't already true! :-)

re: On a related matter, I've heard rumblings that the FDA is considering pulling water off the market...

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To: tuck who wrote (265)10/9/2008 12:44:36 PM
From: tuck
   of 285
 
>>Cardiome Provides Regulatory Update
Thursday October 9, 12:20 pm ET

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."<<

snip

Cheers, Tuck

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To: tuck who wrote (269)11/11/2008 12:33:00 PM
From: keokalani'nui
   of 285
 
Doesn't mean there isn't need for better drug to send AF patients home on, but I'd have to think this may be mentioned in negotiations to license V in chronic AF.

Device to treat atrial fibrillation superior-study
Tue Nov 11, 2008 11:06am EST

CHICAGO, Nov 11 (Reuters) - Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) ablation device outperformed drug therapy for the heart rhythm disorder atrial fibrillation in a study that will be used to seek U.S. regulatory approval for the treatment, J&J said on Tuesday.

Patients who received the catheter ablation treatment were significantly more likely to be free of recurring atrial fibrillation nine months after treatment and had fewer serious side effects after 90 days than those receiving drug therapy, J&J said. The data were presented at a meeting of the American Heart Association in New Orleans.

Atrial fibrillation is the most prevalent heart rhythm disorder, affecting 2.2 million Americans, and a common cause of stroke.

The NaviStar ThermoCool Catheter, manufactured by J&J's Biosense Webster unit, currently is approved in the United States to treat atrial flutter and a form of recurrent ventricular tachycardia after heart attack.

Currently, there are no ablation catheters approved for marketing by the U.S. Food and Drug Administration for the treatment of atrial fibrillation in the United States. However, some doctors use the device to treat atrial fibrillation.

An FDA advisory panel will review J&J's application for an atrial fibrillation indication for the device at a meeting on Nov. 20. FDA officials then would need to consider the panel's recommendation in deciding whether to approval the treatment for atrial fibrillation.

FDA approval would allow the procedure to be promoted specifically for atrial fibrillation.

During cardiac ablation, a catheter is inserted into the heart and energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. The energy disconnects the pathway of the abnormal rhythm.

In the study of 167 people, patients who received catheter ablation treatment showed a 75 percent reduction in recurrence of atrial fibrillation, compared with 21 percent for patients treated with anti-arrhythmic drugs.

"This is the first time in an FDA-monitored, controlled clinical study that catheter ablation has been shown to outperform traditional medical therapy," said Dr. David Wilber, the study's lead author and director of cardiology at Loyola University Medical Center in Maywood, Illinois.

Patients chosen for the study did not respond to at least one type of anti-arrhythmic drug and had at least three atrial fibrillation episodes in the past six months.

The incidence of serious complications such as death, heart attack or stroke in the 90 days following therapy was 18.4 percent for the patients who underwent the ablation procedure, compared with 35.1 percent for those receiving drug therapy. (Editing by Dave Zimmerman)

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From: Ian@SI11/28/2008 5:50:47 PM
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EDIT: TSE:COM actually closed at $5.44CDN. SI quote is a lower number for some unknown reason ($5.39CDN)

Cardiome [t]TSE:COM[/t] (<span style='font-size:11px'>LAST</span>: 0<span style='font-size:11px'> 12:00:00 AM</span>) (<span style='font-size:11px'>LAST</span>: 0<span style='font-size:11px'> 12:00:00 AM</span>) closed up almost 13% in Toronto vs virtually unchanged on the NASDAQ today.

If the CEO's statement is to be taken at face value, it was rather unfortunate that he couldn't have held out a bit longer.

+++++++++++++++++++++++

Cardiome Discloses Chairman And CEO's Involuntary Share Sale

cnw

NASDAQ: CRME TSX: COM

VANCOUVER, Nov. 28 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today disclosed that its Chairman and Chief Executive Officer, Bob Rieder, was recently subject to involuntary margin sales of 45,000 common shares from his direct holding of Cardiome stock.

Mr. Rieder commented, "I am very disappointed to have been required to involuntarily sell any shares of Cardiome, particularly at such an inopportune time; however the global financial crisis and associated market decline has had a profound impact on all stocks including our own. Since joining Cardiome as CEO in 1998, I have always practiced my belief that the leader of a company should have a direct and material financial stake in the company's success, and I have consistently held a substantial proportion of my personal assets in Cardiome shares. My faith and confidence in Cardiome's success is absolutely undiminished as we drive the company forward to the exciting times that lie ahead."

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To: Ian@SI who wrote (271)11/28/2008 6:01:48 PM
From: rkrw
   of 285
 
Amazes me that ceo's and crme is far from the first make their typical $1M in salary/bonus, tons of annual ATM like option grants and yet still are so deep into margin that they get forced sales. I'm sure they'll give this clown an extra 45,000 share grant or free equity to make up for it.

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To: rkrw who wrote (272)12/18/2008 10:37:56 AM
From: keokalani'nui
   of 285
 
no message

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From: Ian@SI4/2/2009 12:50:42 PM
   of 285
 
Insider selling: Another margin call

TORONTO (DOW JONES)--Cardiome Pharma Corp.'s (CRME) chairman and chief executive sold more Cardiome shares in March, once again because of margin calls.

According to insider-trading filings, Bob Rieder sold 37,000 shares between March 9 and March 18. Remarks for each of the trades say "securities sold upon broker decision pursuant to margin call based on pre-existing margin agreement."

In November, the company said Rieder was "subject to involuntary margin sales" totaling 45,000 Cardiome shares. At the time, Rieder said in a release that he was disappointed by the sales, but that his faith and confidence in Cardiome was "absolutely undiminished." The company had no comment on the most recent sales.

After the most recent sales, Rieder still owns about 140,000 shares.

Insider selling is generally frowned upon by investors, and Cardiome shareholders have a lot to be anxious about these days.

"There is a lot of uncertainty on the Street," said one analyst, adding that even though the sales are for personal reasons, investors don't like to see it, especially at such an "important juncture."

On Monday, the company released 2008 financials and said it would announce the timing of a conference call "within the next week" to discuss the results and provide a corporate update, which raised speculation it could be close to some type of deal.

About a year ago, Cardiome undertook a strategic review to help it find a partner for an oral form of its lead drug, vernakalent, a treatment for atrial fibrillation (irregular heartbeat), or to possibly sell the company outright.

But some observers have been skeptical about its ability to succeed, given that the injectable form of vernakalent continues to be held up at the U.S. Food and Drug Administration, despite an independent panel's recommendation for approval in December 2007. It received an approvable letter in August - six months later than expected - and held a meeting with the FDA in November. But there's been no news since then.

In Cardiome's annual information form filed this week, it said development partner Astellas Pharma Inc. (4503.TO) continues to work toward responding to the approvable letter, and it could result in Astellas submitting a complete response, appealing one or more of the "procedural or action issues" related to the submission, or conducting another study.

The analyst said the more time that passes, the more frustrated investors get. Although the stock has gained about 5% Wednesday and Thursday, it's still down more than 30% since the start of the year.

On Nasdaq Thursday, Cardiome is up 5 cents to $3.09.

Company Web Site: cardiome.com

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From: Ian@SI4/8/2009 8:18:50 PM
   of 285
 
Merck & Co., Inc. and Cardiome Sign License Agreement for Vernakalant, an Investigational Drug for Treatment of Atrial Fibrillation

WHITEHOUSE STATION, NJ and VANCOUVER, April 8 /CNW/ - Merck & Co., Inc. and Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today 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 Merck with exclusive global rights to the oral formulation of vernakalant (vernakalant (oral)) for the maintenance of normal heart rhythm in patients with atrial fibrillation, and provides a Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to the intravenous (IV) formulation of vernakalant (vernakalant (IV)) for rapid conversion of acute atrial fibrillation to normal heart rhythm.

"This agreement underscores Merck's ongoing commitment to the research and development of new cardiovascular drugs," said Luciano Rossetti M.D., senior vice president and franchise head, Atherosclerosis and Cardiovascular, Merck Research Laboratories. "Vernakalant is an important addition to our broad portfolio of products and candidates that target multiple aspects of heart disease."

"Given Merck's long-established leadership in the cardiovascular space, we believe there is no company better suited to advance vernakalant," said Bob Rieder, chairman and chief executive officer of Cardiome. "This collaboration places Cardiome in a strong financial position as we conclude our strategic review, and moves the Company closer to providing doctors with an important tool to address this critical unmet medical need."

Under terms of the agreement, Merck will pay Cardiome an initial fee of US$60 million. In addition, Cardiome is eligible to receive up to US$200 million in payments based on achievement of certain milestones associated with the development and approval of vernakalant products (including a total of US$35 million for initiation of a planned Phase III program for vernakalant (oral) and submission for regulatory approval in Europe of vernakalant (IV)), and up to US$100 million for milestones associated with approvals in other subsequent indications of both the intravenous and oral formulations. Also, Cardiome will receive tiered royalty payments on sales of any approved products and has the potential to receive up to US$340 million in milestone payments based on achievement of significant sales thresholds.

Cardiome has retained an option to co-promote vernakalant (oral) with Merck through a hospital-based sales force in the United States. Merck will be responsible for all future costs associated with the development, manufacturing and commercialization of these candidates. Merck has granted Cardiome a secured, interest-bearing credit facility of up to US$100 million that Cardiome may access in tranches over several years commencing in 2010.

Vernakalant (IV) is an investigational candidate being evaluated for its ability to terminate an atrial fibrillation episode and return the heart to normal rhythm. Cardiome's co-development partner in North America, Astellas Pharma U.S., Inc., submitted a New Drug Application with the U.S. Food and Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection in December 2006 that included results from two pivotal Phase III clinical trials. In December 2007, the Cardiovascular and Renal Drugs Advisory Committee recommended that the FDA approve vernakalant (IV) for rapid conversion of atrial fibrillation. In August 2008, the FDA issued an Approvable action letter requesting additional information.

Vernakalant (oral) is being evaluated as an oral maintenance therapy for the long-term prevention of atrial fibrillation recurrence. A Phase IIb double-blind, placebo-controlled, randomized, dose-ranging clinical trial in patients at risk of recurrent atrial fibrillation showed that at the 500 mg dose, vernakalant (oral) significantly reduced the rate of atrial fibrillation relapse as compared to placebo.

The effectiveness of the collaboration agreement is subject to the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, if applicable, as well as other customary closing conditions. The agreement between Cardiome and Astellas Pharma U.S., Inc. for vernakalant (IV) in the United States, Canada and Mexico is unaffected by this agreement.

About Atrial Fibrillation

[SNIP]

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