Cardiome Pharma Corp (NASDAQ:CRME)

CAPS Rating: 1 out of 5

Life sciences company focused on developing proprietary drugs to treat or prevent cardiovascular diseases. Current efforts are focused on the treatment of atrial arrhythmias and congestive heart failure.

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2
Player Avatar portefeuille (99.59) Submitted: 8/30/2009 8:12:32 AM : Outperform Start Price: $21.10 CRME Score: +91.30

Cardiome Announces Upcoming Presentation Of Results Of Phase 2b Clinical Trial Of Vernakalant (Oral) At The European Society Of Cardiology Congress 2009 -> http://finance.yahoo.com/news/Cardiome-Announces-Upcoming-prnews-3013527373.html?x=0. Cardiome Pharma Corp. Announces Tender Offer To Purchase Up To US$27.5 Million Of Its Common Shares -> http://finance.yahoo.com/news/Cardiome-Pharma-Corp-prnews-1933342574.html?x=0.
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John C. writes, "As a practicing physician and an investor, I have been anxiously awaiting the FDA's decision for Cardiome's(CRME Quote) atrial fibrillation medication. Is it unusual for them to take so long? This is potentially a very useful drug and all that I have read about it makes me think it is safe and effective. I don't understand the FDA's seeming reluctance to give it approval."

I don't think anyone really understands why the FDA has held up approval of Cardiome's drug intravenous vernakalant for what is now almost 18 months (dating back to the original FDA decision date in January 2008).

Cardiome and its partner Astellas have said little, and of course, neither has the FDA. Honestly, I think most investors have given up and moved on. In April, Cardiome licensed ex-U.S. rights to the drug to Merck(MRK Quote) along with worldwide rights to the oral version of vernakalant.

The vernakalant pill, if successfully developed, could be a very big drug, so attention is probably more focused on that program today. Merck is expected to start a phase III program for the drug in early 2010.
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http://www.thestreet.com/story/10509765/4/.

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Member Avatar portefeuille (99.59) Submitted: 8/30/2009 5:54:55 PM
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I just listened to the CRME Q2 2009 conference call (http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2773760) and in the Q&A part the CEO says that "We feel that our stock is trading somewhere between a third and a half of true value." and I tend to agree.

Also it should be noted that they are buying back stock, which the CEO "admits" is highly unusual for a company at their stage. I don't care about the effects of the buy back itself but on the message it sends. And I don't think this is just a cheap trick but rather an expression of their genuine feeling that they are to an absurd level undervalued. The stock opened after the earnings announcement (http://finance.yahoo.com/news/Additional-Clinical-Trial-to-prnews-1827904743.html?x=0) at $4.20. It closed on Friday at $4.46, so you have not really missed anything since then.

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Cardiome Announces Upcoming Presentation Of Results Of Phase 2b Clinical Trial Of Vernakalant (Oral) At The European Society Of Cardiology Congress 2009

Press Release

Source: Cardiome Pharma Corp. On Friday August 28, 2009, 1:30 pm EDT

NASDAQ: CRME TSX: COM

VANCOUVER, Aug. 28 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that Dr. Christian Torp-Pedersen is scheduled to present detailed findings from the Phase 2b clinical trial of vernakalant (oral) at the European Society of Cardiology (ESC) Congress 2009, being held in Barcelona, Spain from August 29 to September 2, 2009. The presentation, titled "Oral vernakalant for the prevention of atrial fibrillation recurrence post-cardioversion," is scheduled for Monday, August 31, 2009 at 4:45pm local time.

Positive top-line results from the Phase 2b trial were originally announced in July 2008. The 735-patient double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral) over 90 days of dosing in patients at risk of recurrent atrial fibrillation.

Further information about ESC Congress 2009 can be found at www.escardio.org.

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 Global Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.

...

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So if you want to buy CRME Monday 9 am might be a good time to do that. Also have a look at this "pitch" by dividendsrg8t85.

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dividendsrg8t85 (30.27) Submitted: 1/8/2008 3:56:03 PM :

Vernakalant (IV) is almost a lock for FDA approval. It is the first drug of its type to hit the market in eight years.

The death in the study had NOTHING to do with the drug and if people, including analysts, would read the entire report instead of the front page they would see that the FDA report and the advisory panel were very optimistic about the drug, they were, however, dissappointed that the drug was not tested on stroke patients, but once the drug is approved it will be used for off label use just like many other drugs on the market.

The real value of this company lies with the oral version of vernakalant. If the company reports positive phase 2B results we should see a large spike in the share price because of the potential market for the oral, estimated at 3 billion dollars.

If you want to see what the potential for an oral drug in a market where there is currently none, look at RIGL. It shot from $8 to $31 just on positive phase 2 results and they don't even have the financial position to take the drug to market much less continue research without raising more capital. Cardiome is in a much better financial position with royalties coming after the IV gets approved and around 90 million in cash.

Cardiome will have a variety of options it can pursue if the phase 2B results are good they include taking a partner, being acquired, and taking the drug to market themselves, all of which should be beneficial to shareholders in varying degrees.

This is a good stock play for speculative money. I recently purchased more at $8.60 in anticipation of good news in march.

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So now, over 20 months after that pitch was written those findings from the Phase 2b clinical trial of vernakalant (oral) are to be announced on Monday, August 31, 2009 at 4:45pm local time. 4:45 pm in Barcelona is 10:45 am ET.

Member Avatar portefeuille (99.59) Submitted: 8/30/2009 5:59:11 PM
Recs: 0

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zzlangerhans (99.21) Submitted: 10/4/2008 5:53:51 PM : Start Price: $7.78 CRME Score: -31.01

Despite some obvious speed bumps, I think Cardiome remains significantly undervalued given the prospects for both IV and oral vernakalant. While the process is certainly frustrating for impatient investors, the eventual payoff is likely to be very high. I wouldn't be surprised if the share price is four or five times higher in two years, and there's no telling when in that two years the rise will occur. I closed one outperform as the S&P drop gave me a positive score, and I've now re-entered at a lower price hoping for an eventual three or four hundred points. The bottom line is that the vernakalant data is good, the need for the drug is certainly there, and there's definitely potential for it to be a game changer in the emergency management of atrial fibrillation. I see Cardiome, Arena, and Ligand as the most undervalued small cap biotechs in the current market.

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(from here -> http://caps.fool.com/Pitch/CRME/3093896/despite-some-obvious-speed-bum.aspx)
So tomorrow might be an interesting day for CRME but there will be more of those in the not so distant future I guess. And announcements by biotech companies are not always "pleasant" surprises for investors ...

*** zzlangerhans (99.21) Submitted: 10/4/2008 5:53:51 PM *** did you notice the date?

Member Avatar nilesgold (21.45) Submitted: 9/12/2009 6:01:28 PM
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Do you have any info on the results that were presented at the European Society Of Cardiology Congress 2009? I was unable to find anything further about it.

Member Avatar portefeuille (99.59) Submitted: 9/23/2009 3:34:27 PM
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Oral vernakalant for the prevention of atrial fibrillation recurrence post-cardioversion -> http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=2780

Member Avatar portefeuille (99.59) Submitted: 9/23/2009 3:41:56 PM
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that is the presentation Torp-Pedersen gave on 08/31/09 (see http://www.escardio.org/congresses/esc-2009/congress-topic/Pages/arrhythmias.aspx).

Member Avatar portefeuille (99.59) Submitted: 10/6/2009 8:57:33 PM
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JMP Securities Healthcare Conference
Monday, October 5, 2009 - 12:00pm Eastern (9:00am Pacific)
Webcast -> http://www.wsw.com/webcast/jmp9/crme/

Member Avatar portefeuille (99.59) Submitted: 12/20/2009 1:30:09 PM
Recs: 0

Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study -> http://finance.yahoo.com/news/Cardiome-Announces-prnews-1641237433.html?x=0&.v=15.

Member Avatar portefeuille (99.59) Submitted: 6/25/2010 11:12:42 AM
Recs: 0

Investigational BRINAVESS (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for the Rapid Conversion of Recent Onset Atrial Fibrillation -> http://finance.yahoo.com/news/Investigational-BRINAVESS-bw-3082803584.html?x=0&.v=1.

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