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   Biotech / MedicalCardiome -- CRME


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To: kenhott who wrote (257)7/14/2008 9:49:56 AM
From: dr.praveen
   of 285
 
I thought the results were good and no ambiguities. Is there anything which concerns you?

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From: tnsaf7/14/2008 1:22:20 PM
   of 285
 
Cardiome shares surge on positive heart drug data
Monday July 14, 12:09 pm ET
Cardiome Pharma shares jump as oral drug reduces relapse of abnormal heart rhythm in study

NEW YORK (AP) -- Shares of Cardiome Pharma Corp. surged Monday after the company said the oral version of its developing abnormal heart rhythm drug vernakalant reduced the relapse rate for patients in a midstage study.

The Canadian drug developer said a 500-milligram dose of vernakalant cut the relapse time for patients to more than 90 days in the midstage study, compared with just 27 days for patients taking placebo.

Cardiome stock jumped $2.18, or 26 percent, to $10.52 in midday trading. Shares have traded in a 52-week range of $5.78 to $12.62.

More than 2 million Americans have an abnormal heart rhythm condition, according to the American Heart Association. The condition puts people at a higher risk for blood clots and stroke.

The results come as the company continues to weigh its future in an ongoing strategic review, which could result in a partnership or a possible sale.

Cardiome plans to move ahead with a late-stage study on the 500-milligram dose. Meanwhile, it is still waiting for a Food and Drug Administration decision on an intravenous version of the drug, called Kynapid.

"With 949 patients and subjects exposed to vernakalant (oral) in this development program, we now have an extensive safety and efficacy dataset to guide us as we move this exciting clinical program forward and finalize our strategic discussions with interested parties," said Bob Rieder, chairman and chief executive, in a statement.

Wall Street mostly expected positive results from the midstage study, based on prior interim data. Several analysts also expect the announcement to boost the company's bargaining power. In March, Cardiome retained Merrill Lynch as its financial adviser to pursue partnerships or a possible sale of the company, and noted it has received interest from other drug makers about vernakalant opportunities.

"Management has previously indicated they expect to announce the final outcome from the strategic review within a couple of weeks after releasing today's final oral data as all potential partners/acquirors have completed their due diligence," wrote RBC Capital Markets analyst Philippa Flint in a note to investors. "Since the data were consistent with previously announced interim data, we believe that all that is likely left to do is to finalize the price of any potential deal."

Flint reaffirmed a "Outperform" rating on the stock.

Meanwhile, Oppenheimer & Co. analyst Bret Holley reaffirmed a "Outperform" rating on the stock, saying the likelihood of a buyout is now higher.

Lehman Brothers analyst Dr. Charles Birchenough took a more cautious view Monday, reaffirming a "Equal Weight" rating as the company continues to wait for an FDA decision on Kynapid as it undergoes the strategic review.

"Focus now rotates to Kynapid (intravenous) approval and completion of strategic options review and we believe a delay in both creates significant overhang on Cardiome shares," he wrote in a note to investors.

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To: dr.praveen who wrote (258)7/15/2008 6:50:29 AM
From: kenhott
   of 285
 
My issue with CRME is one of valuation. Because ultimately I think they will have to do an outcome trial to get approve for the oral which is where most of the value is. Outcome trials are not cheap or short or easy but high risk. I am also just following my playbook of trading in between events with CRME. The phase 2 data event was a pretty low risk event in my playbook.

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To: kenhott who wrote (260)7/15/2008 12:10:39 PM
From: Ian@SI
   of 285
 
Haven't they put themselves on auction looking for a sale prior to an Oral V PhIII?

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To: Ian@SI who wrote (261)7/16/2008 6:52:57 AM
From: kenhott
   of 285
 
I believe you are correct. But it takes two to tango. So whomever decides to move on CRME at today's price or higher has to either not fully understand the costs and risks to pursuit the oral or has a better understand than me. I am just trading from point to point. So far ok, tomorrow may require a doctor visit. But that is just the way it is.

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To: Ian@SI who wrote (261)7/16/2008 7:59:28 PM
From: Ian@SI
   of 285
 
Kenm

RBC seems to share your view...

10:05 am Cardiome Pharma: . Target $13.5. RBC Capital Mkts downgrades CRME to Sector Perform from Outperform and sets target price at $13.50 saying they estimate a 60% probability of a partnership versus 40% for a takeout. Over the coming 12-months they expect news such as Kynapid sales, start of the phase III oral program, and Cardiome to start shopping for pipeline products. Although they believe CRME's shares should be more highly valued on a partnership deal, they believe large investors may see the lack of future news flow as an opportunity for profit-taking. With a partnership agreement, they would not be surprised if profit-taking resulted in the shares losing 10-20% of their value over the mid-term. They believe investors should hold shares but they would not be buyers at current levels.

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From: Ian@SI7/23/2008 2:15:38 PM
   of 285
 
Unsure what's driving this: Potential buyers playing hardball?, or, a perk for an early investor?

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

Cardiome Announces Preferred Share Financing

14:10 EDT Wednesday, July 23, 2008

NASDAQ: CRME

TSX: COM

VANCOUVER, July 23 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) today announced that it has entered into an agreement with CR Intrinsic Investments, LLC, an investment fund managed by CR Intrinsic Investors, LLC, an affiliate of S.A.C. Capital Advisors, LLC to purchase Series A convertible preferred shares for gross proceeds of US$25 million. Proceeds of the financing will be used for general corporate purposes, costs associated with the ongoing strategic process and continued development of Cardiome's clinical programs.

"We view this transaction as an important bridge which provides us with additional near-term financial flexibility and a strengthened balance sheet as we enter an important phase of our current strategic discussions," said Doug Janzen, President and Chief Business Officer of Cardiome. "We are pleased that our largest shareholder is willing to support Cardiome with a transaction which will assist us in maximizing the value of our vernakalant franchise following our recent positive oral data."

Under the non-brokered private placement, Cardiome has entered into an agreement to sell 2,272,727 Series A convertible preferred shares at a price of US$11.00 per share for gross proceeds of US$25 million to CR Intrinsic Investments, LLC. Subject to certain timing restrictions, the preferred shares will be convertible into common shares of Cardiome on a 1-to-1 basis. In the event of a change of control of the Company, each preferred share will automatically convert immediately prior to the closing of the change of control event. No coupon or interest is payable on this series of preferred shares. Closing of the transaction is subject to the fulfillment of customary and usual closing conditions.

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From: tuck8/11/2008 9:55:50 AM
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>>Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For KYNAPID(TM)
Monday August 11, 9:18 am ET
NASDAQ: CRME TSX: COM

VANCOUVER and DEERFIELD, IL, Aug. 11 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have received an action letter dated August 8, 2008 from the U.S. Food and Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection for the treatment of atrial fibrillation (AF) - a potentially life-threatening condition that occurs when electrical signals in the heart malfunction. KYNAPID is under review for the rapid conversion of AF to sinus rhythm.

In the action letter, the FDA informed the sponsor (Astellas) that it has completed its review of the KYNAPID NDA and that the application is approvable. 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. Cardiome and Astellas will work closely with the FDA to address all issues raised in the approvable letter.

"Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response," stated Bob Rieder, Chief Executive Officer and Chairman of Cardiome. "While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."

"Astellas and Cardiome strongly believe in the therapeutic value of KYNAPID based on clinical trial data and are confident it will be an important therapy in the treatment of atrial fibrillation," said William E. Fitzsimmons, PharmD, Senior Vice President, Research & Development at Astellas.

In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize KYNAPID in North America. Cardiome retains worldwide rights to vernakalant (oral) for the prevention of AF recurrence and all rights to the intravenous formulations outside of Canada, U.S. and Mexico. The NDA for KYNAPID, based on a five-year clinical development program, was submitted in December 2006.<<

I have vague memories about a safety issue in a subset, but can't find my notes on this. I seem to remember a cardiologist consultant on a conference call, saying he didn't think it would be a deal breaker. Oh, well.

Stock getting beaten back down into the $7s on this.

Cheers, Tuck

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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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