portefeuille (99.75)

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#1) On August 30, 2009 at 9:09 AM, portefeuille (99.75) wrote:

enlarge

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#2) On August 30, 2009 at 9:15 AM, portefeuille (99.75) wrote:

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

Cardiome Pharma Corp. Announces Tender Offer To Purchase Up To US$27.5 Million Of Its Common Shares

Cardiome Reports Second Quarter Results

Additional Clinical Trial to be Conducted for KYNAPID Under FDA Special Protocol Agreement

 

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#3) On August 30, 2009 at 9:16 AM, portefeuille (99.75) wrote:

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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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(from here)

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#4) On August 30, 2009 at 9:43 AM, portefeuille (99.75) wrote:

says that "We

says "We

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#5) On August 30, 2009 at 9:51 AM, portefeuille (99.75) wrote:

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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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#6) On August 30, 2009 at 10:00 AM, portefeuille (99.75) wrote:

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.

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#7) On August 30, 2009 at 10:03 AM, portefeuille (99.75) wrote:

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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)

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#8) On August 30, 2009 at 10:31 AM, portefeuille (99.75) wrote:

the march 2009 rally (more on this here).

 

enlarge

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#9) On August 30, 2009 at 10:32 AM, portefeuille (99.75) wrote:

************************************************************************************

a guide to my blog posts can be found in the comment section to this post

(should be the last comment or close to that)                                                                

************************************************************************************

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#10) On August 30, 2009 at 10:33 AM, portefeuille (99.75) wrote:

how about this. do not recommend this post. recommend my best post.

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#11) On August 30, 2009 at 10:59 AM, JakilaTheHun (99.93) wrote:

do not recommend this post

But I like this post.   Besides, I thought the other post was for saying "Hi" to Mom. ;)

 

(Actually, I've already rec'd the other post)

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#12) On August 30, 2009 at 11:26 AM, portefeuille (99.75) wrote:

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.

Well it is back to around $8. It closed on Friday at $7.28.

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#691) On August 09, 2009 at 2:44 AM, portefeuille (99.98) wrote: RIGL - 8.62 - outperform

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#13) On August 30, 2009 at 11:27 AM, portefeuille (99.75) wrote:

my super post got its recommendation #22. thank you!

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#14) On August 30, 2009 at 5:07 PM, portefeuille (99.75) wrote:

"how strongly the fell about"

"how strongly they feel about"

 

("how strong they feel", "how strong their feelings are towards"? I guess you know what I meant, hehe ...)

 

25 recommendations, I guess the diversion of recommendations is working. Thank you guys!

 

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#15) On August 30, 2009 at 7:49 PM, portefeuille (99.75) wrote:

how about some more comments not made by me?

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#16) On August 30, 2009 at 8:08 PM, Tastylunch (29.97) wrote:

What indeed is going on with Cardiome's drug approval? 18 months is not a good sign

Perhapa it is safe but not as effective as anticipated?

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#17) On August 30, 2009 at 8:45 PM, DEALWITHTHEDAY (37.68) wrote:

I went out and looked at CRME. I will continue to research as tool I use shows no debt and a good value, 75 million cash. I do not see what is holding it back but I need to see what they have to new to bring on. Thanks Portefeuille. I will look over the others you mention. I have been looking for areas to go as I reduce some of my positions. I appreciate it.

Did some quick research and a 25.7 million buy back. An increase of 8.4 million from last year. I drug to help heart problems while they are happening and may happen. I will be there at 9:00 A.M. I have a feeling the stock repurchase will push it to the $5.10 side of the pick Thanks great information. 

 

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#18) On August 30, 2009 at 8:53 PM, DEALWITHTHEDAY (37.68) wrote:

I went out and looked at DB. It has returned to 50% of to is approx. $140 high. If was got to wait for a pull back to 62 or 60. Portefeuille if the market pull back 5 to 10 percent do you see this pull back to this point.

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#19) On August 30, 2009 at 9:01 PM, portefeuille (99.75) wrote:

The stock repurchase is old news. That made it rise on Wednesday (08/26/09). I only mentioned the exact time of that presentation because it is tomorrow and it may be a good thing to buy it (IF you want to buy it) before the presentation. But that presentation may not be all that important ...

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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.

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You should listen to the Q2 earnings conference call. They are not entirely sure why it takes so long themselves. Just listen to the first few minutes ...

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#20) On August 30, 2009 at 9:23 PM, portefeuille (99.75) wrote:

Those stocks are more or less "long-term" holdings of mine. I don't see all that much "value" in me providing information on my holdings, but as I said, people around here seems to be interested in it. If you want to know "real time" when I really like a stock and maybe also when I don't like it "all that much" any more you can simply follow the post with my list of calls. I try to change my "outperform" calls to "market perform" or simply end the calls when I think that "the easy money has been made". But sometimes I really end them to early as was the case with HGSI (see comments #595,596 here). So if someone wants to follow my calls the intended "usage" if probably to buy when I make an "outperform" call and to just let it run (but not add) or take some profit if it is up by quite a bit and I change my call. I think I am better at buying than at selling, hehe ...

Someone has written that the list is a good way to see what I am currently interested in (if I remember that right. Maybe that was a comment on how to use "caps" game calls in general, I simply don't remember.). I think that is the perfect way to use my calls! What someone did write is something like "just following portefeuille's list is a lot of work", hehe. But hey, I just wanted to tell people that the list exists, and not brag. After all it is just a list that lets me make all the calls I want to make, not just the ones the "caps" game lets me make.

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#21) On August 30, 2009 at 9:53 PM, portefeuille (99.75) wrote:

to early

too early

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#22) On August 30, 2009 at 9:56 PM, DEALWITHTHEDAY (37.68) wrote:

I will read the Call for CRME. I realize that you cannot or should not give me direct advice and sometimes I am to straight forward with my comments and information. I make my decision based upon my research. But I do appreciate you putting your information out their. There is so much to review and I am not a Pro but it gives me places to start. Thanks.

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#23) On August 30, 2009 at 10:10 PM, TMFJake (53.39) wrote:

Thanks for shining a light on CRME.  Looks interesting...

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#24) On August 30, 2009 at 11:00 PM, portefeuille (99.75) wrote:

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New Drugs Surprise In Barcelona

Matthew Herper, 08.30.09, 02:00 AM EDT

Study data at a European cardiology meeting could boost two experimental blood thinners.

Two experimental pills that weren't on anybody's radar screen six months ago delivered impressive clinical trial results at the annual meeting of the European Society for Cardiology in Barcelona.
These medicines are blood thinners, drugs that prevent the clots that cause heart attacks and strokes and one of the few big cardiology markets left. Brilinta, from London-based drug giant AstraZeneca ( AZN - news - people ), was shown in the study to prevent heart attacks and deaths better than Plavix, the second-best-selling drug in the world. Dabigatran, manufactured by privately held German company Boehringer Ingelheim, outperformed warfarin, a 60-year-old drug used to prevent strokes.
"Both these agents appear to be significant advances," says Deepak Bhatt, chief of cardiology at the Boston VA Healthcare System, who was not associated with either study. "The major challenge now will be picking the ideal agent for individual patients."
And both medicines, despite some real drawbacks, represent sneak attacks on more hyped drugs on which companies including Eli Lilly ( LLY - news - people ), Bayer ( BAY - news - people ) and Johnson & Johnson ( JNJ - news - people ) are pinning high hopes. The New England Journal of Medicine is publishing articles on both agents, along with favorable editorials.
Brilinta is similar to Plavix, the $8.6 billion-per-year drug from Bristol-Myers Squibb ( BMY - news - people ) and Sanofi-Aventis ( SNY - news - people ), in that it prevents blood cells called platelets from clumping together to form clots. But in a study of 18,600 patients who presented to the hospital with chest pain, 10% of those who got Brilinta had heart attacks, strokes, or died compared with 12% who received Plavix, a statistically significant 16% decrease.

...

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#404) On March 30, 2009 at 10:50 AM, portefeuille (99.98) wrote: AZN - 33.20 - outperform

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#644) On August 01, 2009 at 9:59 PM, portefeuille (99.98) wrote: AZN - end outperform - 46.90 - new rating: market perform

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currently at ca. $46.32.

 

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#25) On August 30, 2009 at 11:13 PM, portefeuille (99.75) wrote:

Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor (03/17/08)

Cardiome Announces Positive Phase 2b Results For Oral Vernakalant (07/14/08)

 

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#26) On August 30, 2009 at 11:22 PM, uclayoda87 (29.91) wrote:

Some facts about atrial fibrillation from a cardiologist who has practiced 20+ years and recently passed the recertification exam.

The main problem with atrial fibrillation is that it increases the risk of stroke, expecially in people over 60 years old.  It can also exacerbate heart failure and give people palpitations and general malaise.

It is a common problem, which has been studied extensively.  We know that control of hypertension with ACE inhibitors and ARBs may help prevent the fibrosis that develops in the atria, which appears to preceed the development of atrial fibrillation.

Many drugs have been used to try to prevent the development of atrial fib, but when matched up against rate control and anticoagulation, less strokes were seen in patients treated with anticoagulation.

Over the last 10 years, atrial fibrillation ablation has become more successful in treating atrial fibrillation, especially if it is recent in onset and the atria have not already enlarged.

If you want to invest in the hype associated with a new atrial fibrillation drug for a short term profit that's OK, but it really won't work, so don't be surprised if the stock tanks.

For more information concerning atrial fibrillation, look at the American College of Cardiology web site, specifically its practice guidelines/position papers.

 

 

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#27) On August 30, 2009 at 11:28 PM, Tastylunch (29.97) wrote:

Well knowing what I know about the FDA this length of wait is very unusal for phase II B results. Especially since there is approximately 60%+ pass rate by the time you make it that far.

4:45 in Barceleona, so that would be what 11:45 Am Eastern (US)? Or is Spain 6 hours ahead?

ah comment #622 I see what you did there

 Yeah when to sell is a question that very few seem to have answer to.

I guess perhaps a wide stop limit GTC order might be the best way to go so you don't cut winners too early.

Unfortunately this may be the worst thing CAPS does as it encourages taking wins early but letting losses run.

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#28) On August 30, 2009 at 11:32 PM, Tastylunch (29.97) wrote:

uclayoda87

that would make sense for why it could be hung up in trials.

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#29) On August 30, 2009 at 11:37 PM, portefeuille (99.75) wrote:

Or is Spain 6 hours ahead?

Yes, 6 hours for Barcelona, una hora menos en Canarias, hehe ...

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#30) On August 31, 2009 at 12:10 AM, portefeuille (99.75) wrote:

I am not really that bad at selling, just slightly better at buying, I guess. I have never used a stop loss limit. And I would recommend not using them especially for biotech stocks (and especially^2 for "thinly traded" ones). I did not want to give the impression that the CRME management is "clueless" on what is going on. As I said before you get a good impression by listening to the first few minutes of the Q2 earnings call. And do have a look at the articles I linked to. And this is about oral vernakalant. The iv version is "further down the approval process" already. What you write, uclayoda87, is not specific to the drugs in question. And the "huge unmet need" aspect of what you write is of course one of the reason why the stock price might have quite a bit of upside potential. I also did not want to create the impression that there is a free lunch here. But someone who would have followed the biotech calls I made in my list would have done quite well (at least he would have had to be extremely unlucky to not "make money" following those calls. And yes, it would have been okay to listen to just every 10th biotech call or every biotech call I made on a Wednesday, hehe). Just stay somewhat diversified. My "by far largest" position (EMC shares and call options) do not make up more than 20% of my portfolio.

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#31) On August 31, 2009 at 12:14 AM, Tastylunch (29.97) wrote:

Danke!

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#32) On August 31, 2009 at 12:17 AM, portefeuille (99.75) wrote:

And no, I am not a biotech expert, not a physician, just a theoretical physicist, so be scared, hehe. I am somewhat familiar with the subject.

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#33) On August 31, 2009 at 12:57 AM, BigFatBEAR (30.21) wrote:

Port...  thank you very much! I think "real holdings" show where your money is...   when most of CAPS is about where your "mouth" is. If the 2 are aligned...  well, all the better. :)

I have a question. Why should I buy EMC, which looks to be fully-valued at 2X book and 2X sales? It also has no dividend. I'm honestly not that attracted to EMC stock at first glance.

My current oil fave, TOT, looks less-loved recently by the markets (making it less risky to me), and has a nice 5% yield. Zacks had a decent write-up of it recently.

If you can convince me why EMC is better than TOT, I'll give you $5, and perhaps invest a bit in EMC. :)

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#34) On August 31, 2009 at 9:49 AM, NYCFOOLIO (< 20) wrote:

thanks for the new post and insight and information Port...awesome...cant wait to read all this and do some research...thanks again!

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#35) On August 31, 2009 at 12:21 PM, Tastylunch (29.97) wrote:

Hmmm the conference looks to be a dud, it's been selling off since this morning's spike.

Still it's a worthy play to watch for a Pop.

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#36) On August 31, 2009 at 1:41 PM, portefeuille (99.75) wrote:

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#37) On August 31, 2009 at 1:48 PM, portefeuille (99.75) wrote:

An Echo Chamber of Boom and Bust

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#38) On August 31, 2009 at 2:24 PM, portefeuille (99.75) wrote:

Webcasts from the ESC Congress 2009

 

 

 

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#39) On September 01, 2009 at 1:39 AM, portefeuille (99.75) wrote:

I have added two calls to my list. CLDA and BDSI.

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#40) On September 01, 2009 at 10:43 AM, JakilaTheHun (99.93) wrote:

Don't know if you're still reading this or not, Port, but what do you think about NVAX at the current levels?  I noticed you green thumbed back in December, but it's run up quite a bit since then. 

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#41) On September 01, 2009 at 4:59 PM, TigerPack1 (99.70) wrote:

portefeuille- 

I see you added TRBN to your buy list. 

Why didn't FACT just buy out TRBN either for cash or an all stock deal?

They could swing for all the expenses to fund a total of 7-8 different drug studies for a few years, on their own, with all the cash on hand.  Under this rationale, they could end up keeping most of the "rewards" from potentially 2 or 3 drugs in two years, and up to say 4 or 5 new patented drugs in 3-5 years????

They would have partnership deals with Biogen and Wyeth for the most promising drugs, and potentially create monster returns for FACT shareholders the next 3-5 years!!!

I am assuming the FACT sell-off the past several days on the news is related to Wall Street's read of the TRBN investment as a lack of conviction by management with the in-house drugs under development.  Kind of like moving on to "Plan B."

Plenty of buyers of FACT appeared later in the day, however.  FACT will use some of their cash for similar deals in the future to create more upside than 1% annually on the treasure trove, in my estimation.  I don't have a problem with this decision and am considering buying more FACT in the real world.

What is your take?

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#42) On September 01, 2009 at 5:20 PM, sentinelbrit (92.93) wrote:

I agree with you about showing holdings in real life. For me, I want my real portfolio to resemble my CAPS portfolio because I want to see how well I am doing against other investors - particularly those who think they can trade in and out of the market. My style is not buy and hold but it is certainly not a trading portfolio.

I am currently thinking about raising more cash but intend to hold a minimum amount/% in stocks because I cannot predict what will happen with any degree of consistency and over the long term, I expect equities to provide superior returns to cash.

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#43) On September 01, 2009 at 11:55 PM, portefeuille (99.75) wrote:

Australian Economic Growth Accelerates, Points to Rate Increase

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#44) On September 02, 2009 at 12:04 AM, portefeuille (99.75) wrote:

What is your take?

Maybe they should use some of their cash for acquisitions, but deals like the one with TRBN seem to be more appropriate. FACT is still one of my "favourite" stocks and I don't see why you should not buy some shares, but you should stay diversified in this sector.

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#45) On September 02, 2009 at 12:09 AM, portefeuille (99.75) wrote:

Don't know if you're still reading this or not, Port, but what do you think about NVAX at the current levels?

I would keep some but not buy any currently.

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#64) On March 05, 2009 at 10:27 AM, portefeuille (99.98) wrote: NVAX - 0.65 - outperform
#549) On July 11, 2009 at 9:48 AM, portefeuille (99.98) wrote: NVAX - end outperform - 2.58 - no new rating
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It is currently at ca. $6.65.

 

 

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#46) On September 02, 2009 at 12:11 AM, portefeuille (99.75) wrote:

... which makes it "up by more than 900%" since I made that "outperform" call.

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#47) On September 02, 2009 at 12:10 PM, TigerPack1 (99.70) wrote:

OK, bought some more FACT around $8.60 today.

I also have been purchasing TBSI and YHOO shares today.

-TigerPack

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#48) On September 02, 2009 at 12:17 PM, DEALWITHTHEDAY (37.68) wrote:

Thanks Portefeuille.

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#49) On September 02, 2009 at 2:43 PM, stockcommander (99.25) wrote:

#4) On May 27, 2009 at 12:32 PM, portefeuille (99.99) wrote: 1 Have you noticed this? Well, I was a bit slow noticing your post, but jepp you are doing great ...  Have you noticed this: http://caps.fool.com/Ticker/GMCR/Chart.aspx?source=icasitcht0000001  I may be wrong - but this looks like a head and shoulder formation in the making

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#50) On September 02, 2009 at 3:11 PM, portefeuille (99.75) wrote:

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Dainippon Sumitomo to bid for Sepracor - Nikkei

Wed Sep 2, 2009 1:53pm EDT

Sept 3 (Reuters) - Japan's Dainippon Sumitomo Pharma Co Ltd (4506.T) plans to launch a bid to acquire Sepracor Inc (SEPR.O) for about 250 billion yen ($2.70 billion), the Nikkei business daily said.

Shares of Marlborough, Massachusetts-based Sepracor jumped as much as 30 percent to $23.37 Wednesday on Nasdaq.

The move is intended to boost Dainippon Sumitomo Pharma's lineup of central nervous system and other drugs, the paper said without citing sources.

Sepracor officials were not immediately available for comment.

Funding for the purchase will come from sources including cash on hand and loans, the Nikkei said.

For the alerts, double-click [ID:nWNAB6130] ($1=92.54 Yen) (Reporting by Anand Basu in Bangalore; Editing by Anthony Kurian)

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#607) On July 25, 2009 at 9:04 PM, portefeuille (99.99) wrote: SEPR - 16.12 - outperform
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#51) On September 02, 2009 at 3:15 PM, portefeuille (99.75) wrote:

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Dainippon to bid about $2.7 billion for Sepracor: source

Wed Sep 2, 2009 3:01pm EDT

By Toni Clarke

BOSTON (Reuters) - Japanese drugmaker Dainippon Sumitomo Pharma Co (4506.T) plans to offer to buy Sepracor Inc (SEPR.O) for about $2.7 billion, a source with knowledge of the situation said Wednesday.

Sepracor, which makes the sleep drug Lunesta and asthma drug Xopenex, is also developing an epilepsy drug, Stedesa, which it acquired with its purchase of Oryx Pharmaceuticals in June last year.

An acquisition of Sepracor by Dainippon would be the latest in a series of U.S. acquisitions by Japanese drugmakers.

News of the proposed transaction was first reported in the Japanese business daily Nikkei.

Astellas Pharma Inc (4503.T) offered earlier this year to acquire U.S. biotechnology company CV Therapeutics for $1 billion. Previously, Takeda Pharmaceutical Co (4502.T) acquired U.S. biotech Millennium Pharmaceuticals for $8.9 billion and Eisai Co Ltd (4523.T) acquired MGI Pharma for $3.9 billion.

Sepracor's shares rose $4.77, or 26.5 percent to $22.80 on Nasdaq before being halted pending news.

($1=92.54 Yen)

(Reporting by Toni Clarke, editing by Gerald E. McCormick)

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(emphasis mine)

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#52) On September 02, 2009 at 3:50 PM, portefeuille (99.75) wrote:

Smart Money Analysis-Hedge funds bet big on BofA, other banks

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#53) On September 02, 2009 at 5:28 PM, TigerPack1 (99.70) wrote:

portefeuille-

Was that your hedge fund that manipulated FACT down all day long, and then bought 800,000 shares the last few minutes of trading???

I figured a big buy order was coming after dissecting the trading patterns yesterday and this morning; I was just a few hours early in my purchases.

Nice job.  See you above $10 a share again in a few weeks!!!

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#54) On September 02, 2009 at 5:50 PM, portefeuille (99.75) wrote:

No, we were too busy putting together a counter bid for Sepracor today.

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#55) On September 02, 2009 at 7:15 PM, portefeuille (99.75) wrote:

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SEPTEMBER 2, 2009, 6:43 P.M. ET

Roche Drug Shrinks Tumors in Study

By RON WINSLOW

An experimental drug designed by Roche Holding AG's Genentech unit against a new cancer target yielded encouraging results against two rare tumors, researchers said, potentially opening up a new front in the battle against the disease.

In a small study, the drug, known as GDC-0449, shrank tumors in 18 of 33 patients, or 55%, with an advanced form of a skin cancer called basal cell carcinoma. In addition, the drug had a dramatic, though temporary, effect on a 26-year-old patient who had undergone multiple surgeries, chemotherapy and radiation in an unsuccessful battle against a brain cancer called medulloblastoma.

While the accounts involve just a handful of patients and the cancers are rare, researchers say the drug's target, called the hedgehog pathway, is believed to be involved in other, more common and hard-to-treat tumors, including colon, pancreatic and ovarian cancers. Merck & Co. and Infinity Pharmaceuticals Inc., Cambridge, Mass., are among other companies developing drugs against the hedgehog pathway. The pathway is so named because geneticists who discovered the gene that is associated with the pathway noticed it had tiny hairs sticking out in multiple directions.

"This defines a new pathway that may have efficacy for multiple tumor types,'' said Charles M. Rudin, associate director for clinical research at the Johns Hopkins Kimmel Cancer Center, and a co-author of two reports on the drug that are being published Thursday in the New England Journal of Medicine.

Genentech, which is collaborating with Curis Inc., Cambridge, Mass., in developing the drug, launched a 100-patient phase 2, or midstage, study early this year. Based in part on the encouraging results of the current trial, the company said it is hopeful that the Food and Drug Administration will consider approving the drug.

But success isn't assured. "The studies are preliminary, and we don't know in the long term how useful this class of drugs will be,'' said Andrzej A. Dlugosz, a researcher at the University of Michigan Comprehensive Cancer Center, Ann Arbor, and co-author of an editorial that accompanied publication of the findings. Still, he said, "hopes are big'' that the responses seen in the trial hold promise for "this being a new approach'' to cancer treatment.

Basal cell carcinoma is the most common skin cancer, affecting about one million Americans annually, but nearly all cases are easily cured with surgery. In very rare cases, the tumor spreads to surrounding tissue, or to other organs, where the prognosis for patients is poor. Medullablastoma is a form of brain tumor that typically afflicts children, but it is rare.

In about 90% of basal cell carcinoma cases and 30% of medullablastoma cases, the cancer is driven by a mutation in the hedgehog pathway.

The pathway plays a key role in prenatal development for several organ systems, but is apparently dormant in adults, a fact that may explain why there were few significant side effects in the study, researchers said. That would make the drug easier to use in combination with chemotherapy in cancers by avoiding an accumulation of side effects.

Getting a response in 55% of participants is unusual in an early stage cancer trial—especially since patients with a variety of tumors are typically enrolled. But researchers suspected, based on animal studies, that patients with basal cell carcinoma would be especially likely to benefit from the drug, and after the first enrolled patient had a significant response, they deliberately sought out more patients with the disease.

"This is a different paradigm for drug development," Dr. Rudin said. By using knowledge of a tumor's molecular mechanisms to help recruit patients, "we can move more quickly and focus our research more on patients who are likely to benefit from therapy," he said.

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(emphasis mine) 

 

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#605) On July 25, 2009 at 5:26 PM, portefeuille (99.99) wrote: CRIS - 1.45 - outperform
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CRIS is currently at ca. $2.79.

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#56) On September 02, 2009 at 7:17 PM, portefeuille (99.75) wrote:

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#607) On July 25, 2009 at 9:04 PM, portefeuille (99.99) wrote: SEPR - 16.12 - outperform
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#605) On July 25, 2009 at 5:26 PM, portefeuille (99.99) wrote: CRIS - 1.45 - outperform
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Let's see what else I recommended on July 25, hehe ...

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#57) On September 02, 2009 at 7:34 PM, portefeuille (99.75) wrote:

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New pill shows promise in hard-to-treat cancers

Wed Sep 2, 2009 5:02pm EDT 

* Genentech, Curis drug GDC-0449 shrank skin cancer tumors

* Brain tumor patient responded, but developed resistance

By Julie Steenhuysen

CHICAGO, Sept 2 (Reuters) - An experimental cancer pill made by Roche's (ROG.VX) Genentech shrank tumors in patients whose skin cancer had spread, raising hope for a new class of drugs that may have an affect on many other cancers as well, U.S. researchers said on Wednesday.

In an early-stage study, the drug being developed in partnership with Curis Inc (CRIS.O), shrank tumors in half of a small group of patients with basal cell skin cancer that had spread to their organs.

The results were so promising they started phase 2 studies. They also have trials in colorectal and ovarian cancer.

But there's a possible hitch.

While the compound -- known as GDC-0449 -- also helped shrink tumors in one patient with an aggressive type of childhood brain cancer called medulloblastoma, that patient eventually developed resistance to it.

The studies, published in the New England Journal of Medicine and the journal Science, offer a first look a promising new class of drugs that block the Hedgehog signaling pathway, which involves several proteins that play a role in cell growth.

It gets its name from fly embryos, which take the shape of spiny little hedgehogs when a gene in the pathway is blocked.

Other companies studying Hedgehog inhibitors include Bristol-Myers Squibb (BMY.N) and partner Exelixis Inc (EXEL.O), and Infinity Pharmaceuticals (INFI.O).

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#58) On September 02, 2009 at 7:35 PM, portefeuille (99.75) wrote:

Curis to Present at the Rodman & Renshaw 11th Annual Healthcare Conference

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#59) On September 02, 2009 at 8:39 PM, DEALWITHTHEDAY (37.68) wrote:

Well if after hours has anything to do with CRIS tomorrow should be something to watch.

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#60) On September 02, 2009 at 8:57 PM, portefeuille (99.75) wrote:

It has risen from $2.10 to $2.75 in after-hours trading.

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#61) On September 02, 2009 at 9:08 PM, DEALWITHTHEDAY (37.68) wrote:

Pharma is one of my short comings. I have had a few good winners but tend to stay away as the amount of detail you have to go through. You and Pharma seem to go hand and hand.

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#62) On September 02, 2009 at 9:40 PM, portefeuille (99.75) wrote:

You and Pharma seem to go hand and hand.

Not sure about that. But I think it is the "fun" sector, if there are any.

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#63) On September 02, 2009 at 9:49 PM, portefeuille (99.75) wrote:

Dainippon in Talks With U.S. Firm

Dainippon Sumitomo Rises on Report It Plans to Buy Sepracor

 

 

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#64) On September 03, 2009 at 12:57 AM, portefeuille (99.75) wrote:

2nd UPDATE: Dainippon Sumitomo In Talks To Buy Sepracor

 

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Dainippon to Buy Sepracor for $2.6B

Joseph Woelfel 09/03/09 - 12:47 AM EDT

OSAKA, Japan (TheStreet) -- Japanese drugmaker Dainippon Sumitomo Pharma confirmed it has reached an agreement to buy Sepracor(SEPR Quote) for $23 a share, or $2.6 billion, in an effort to help sell its Lurasidone drug in the U.S.

Shares of Sepracor closed Thursday at $22.80.

Dainippon plans to file for U.S. marketing approval next year of its experimental schizophrenia drug Lurasidone. The acquisition is seen as a way to gain access to Sepracor's sales force.

Various earlier reports had put the acquisition price at $2.7 billion.

The boards of both companies have approved the deal. Under the terms of the definitive agreement, Dainippon will begin a tender offer no later than Sept. 15 for Sepracor shares at $23 a share.

"Sepracor has pursued growth through development of its unique pipeline and introduction of innovative pharmaceutical products to the market, a strategy that fits perfectly with our management philosophy," said Dainippon President Masayo Tada, in a statement. "We expect that Sepracor will become a 'Center of Excellence' for DSP in the U.S., and will make a significant contribution to DSP both as a commercialization infrastructure for our self-developed products and as a strategically important base for business development."

-- Reported by Joseph Woelfel in New York .

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#65) On September 03, 2009 at 1:06 AM, portefeuille (99.75) wrote:

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Dainippon Sumitomo Will Buy Sepracor for $2.6 Billion (Update1)

By Kanoko Matsuyama and Tom Randall

Sept. 3 (Bloomberg) -- Dainippon Sumitomo Pharma Co. will buy Sepracor Inc. for $2.6 billion to expand in the U.S., the world’s biggest drug market.

Dainippon agreed to pay $23 a share, 28 percent more than Sepracor’s $18.03 closing price on Sept. 1, the Osaka-based company said in a statement today.

Japanese pharmaceutical companies have spent more than $12 billion since 2008 buying U.S. rivals, taking advantage of the yen’s 26 percent gain against the dollar in the past two years to expand in the $291 billion U.S. prescription-drug market. Dainippon, a unit of Japan’s second-biggest chemical company, said the acquisition will add to earnings per share in the year starting April 2011.

“The yen is very strong, and Japanese companies have been very active in this space,” Les Funtleyder, an analyst with Miller Tabak & Co. in New York, said by telephone. “It’s been pretty widely known that Sepracor has been shopping itself for a while. It’s a cheap company, on a valuation basis.”

Marlborough, Massachusetts-based Sepracor rose the most in more than five years on the Nasdaq yesterday before trading in the stock was halted. Jonae R. Barnes, a company spokeswoman, didn’t immediately respond to a voice mail seeking comment after office hours.

First U.S. Drug

Dainippon, the drug unit of Sumitomo Chemical Co., plans to submit its experimental schizophrenia treatment Lurasidone for U.S. regulatory approval in 2010. That would be the first drug sold in the U.S. by the company, which is also developing treatments for diabetes, hypertension, bronchial asthma and allergic rhinitis.

Sepracor is researching drugs including treatments for asthma, allergic rhinitis and insomnia, according to its Web site. Its experimental epilepsy drug, Stedesa, awaits a U.S. decision due by Jan. 30, 2010, while sales of the company’s biggest product, Lunesta, declined in 2008.

“This is a good match,” Yasuhiro Nakazawa, an analyst at Mitsubishi UFJ Securities Co. in Tokyo, said by telephone. “Sepracor is strong in the areas of sleep disorders and respiratory ailments, which are Dainippon Sumitomo’s focus.”

Nomura Holdings Inc. and Thomas Weisel Partners LLC advised Dainippon on the acquisition, according to the drugmaker’s statement.

Takeover Plans

Takeda Pharmaceutical Co. last year acquired Millennium Pharmaceuticals for $8.9 billion and Eisai Co. bought MGI Pharma Inc. for $3.9 billion. Drugmakers in Japan are looking for overseas expansion opportunities to cope with government- mandated price cuts in the domestic market.

Dainippon Sumitomo’s net income dropped 22 percent to 20 billion yen in the year ended March 31. More than 90 percent of its 264 billion yen in full-year sales came from Japan.

Sepracor’s net income jumped more than eightfold to $515 million last year, while revenue rose 5.5 percent to $1.3 billion.

Prescription sales in the U.S. rose 1.3 percent to $291 billion last year, according to Norwalk, Connecticut-based research firm IMS Health Inc. in March.

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#66) On September 03, 2009 at 2:50 AM, portefeuille (99.75) wrote:

Exit Strategy Doubts Remain

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#67) On September 03, 2009 at 7:49 PM, portefeuille (99.75) wrote:

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Curis Announces GDC-0449 Phase I Clinical Data Published in New England Journal of Medicine

Phase I Data in 33 Patients Demonstrates Molecule’s Potential as Treatment for Locally Advanced and Metastatic Basal Cell Carcinoma

Press Release

Source: Curis, Inc.

On Thursday September 3, 2009, 8:00 am EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Curis, Inc. (NASDAQ: CRIS - News), a drug development company focused on developing proprietary targeted medicines for cancer treatment, today announced that two publications describing clinical data generated with GDC-0449 were published in the current edition of The New England Journal of Medicine (NEJM). The first publication, entitled “Inhibition of the Hedgehog Pathway in Advanced Basal-Cell Carcinoma,” provides an overview of the Phase I data for the 33 basal cell carcinoma (BCC) patients treated in this study. The second paper is a case study entitled “Treatment of Medulloblastoma with Hedgehog Pathway Inhibitor GDC-0449,” which provides an overview of the treatment of a single adult medulloblastoma patient with GDC-0449.

"The data published by this distinguished journal build upon the existing body of evidence and provide further support for the belief that aberrant Hedgehog signaling is strongly implicated in solid tumors such as basal cell carcinoma and medulloblastoma,” said Curis President and CEO Dan Passeri. “The ongoing pivotal Phase II clinical trial of GDC-0449 in advanced BCC being conducted by our collaborator Genentech is progressing, and if the trial is successful, may serve as the basis for a future new drug application submission by Genentech. We are also hopeful that Genentech’s ongoing Phase II clinical trials of GDC-0449 in metastatic colorectal cancer and advanced ovarian cancer patients will yield promising data supporting the use of GDC-0449 for ligand-driven cancers.”

Phase I BCC Publication
The publication entitled “Inhibition of the Hedgehog Pathway in Advanced Basal-Cell Carcinoma” provides efficacy, safety, pharmacokinetic and pharmacodynamic data summaries of the 33 BCC patients treated in the Phase I clinical trial.

Efficacy
In 18 patients with metastatic BCC, 8 patients had confirmed partial responses (7 by RECIST and 1 by clinical assessment), 1 patient had an unconfirmed partial response by RECIST, 7 patients had stable disease as a best response and 2 patients had progressive disease. RECIST provides standard parameters to be used when documenting patient response for solid tumors. The overall response rate was 50% (9 partial responses out of the 18 metastatic BCC patients in the study).

In 15 patients with clinically evaluable locally advanced BCC, 2 patients had complete clinical responses, 7 patients had partial responses, 4 patients had stable disease as the best response and 2 patients had progressive disease. The overall response rate was 60% (2 complete responses plus 7 partial responses out of the 15 locally advanced BCC patients in the study).

At the time of the data cut-off for the paper, the median time on study and the median duration of response for these patients was 9.8 and 8.8 months, respectively, with 19 patients still on study.

Safety Summary
In the Phase I study of GDC-0449, no Grade 5 adverse events were observed and there was a single Grade 4 adverse event that was not determined to be related to the study drug. The following Grade 3 adverse events were seen: fatigue (n=4), hyponatremia (n=2), weight loss (n=2), dyspnea (n=2), and one patient each with muscle spasms, atrial fibrillation, aspiration, back pain, corneal abrasion, dehydration, keratitis, lymphopenia, pneumonia, urinary tract infection, a prolonged QT interval, increased serum alkaline phosphatase, and increased serum potassium. Other adverse events were mild to moderate with 11 Grade 2 adverse events that were considered to be related to GDC-0449 treatment and that included muscle spasms (n=3), dysgeusia (n=2), anorexia (n=2), weight decrease (n=2), hypocalcemia (n=1), and dyspnea (n=1).

Pharmacokinetics (PK) and Pharmacodynamics (PD)
GDC-0449 demonstrated a favorable PK and PD profile with a median steady-state plasma concentration of 16.1 micromolar. The median time to reach this steady-state level was 14 days. Dose escalation from 150 mg to 270 mg did not result in higher total plasma concentrations of GDC-0449 and as a result, Genentech has selected a daily dose of 150 mg for the ongoing Phase II clinical trials.

Medulloblastoma Patient Articles in NEJM and Science
A brief report of an adult medulloblastoma patient treated with GDC-0449 was published in the same edition of the New England Journal of Medicine and a related paper was also published today in the online edition of Science. The NEJM brief report discusses a 26-year old medulloblastoma patient who was refractory to multiple prior therapies including surgical resection followed by radiation therapy and chemotherapy. This patient was subsequently treated with GDC-0449, resulting in symptomatic improvement and rapid but transient tumor regression. The authors of this report note that it marks the first demonstration of medulloblastoma tumor regression in a patient with a Hedgehog pathway inhibitor who had significant tumor burden and extensive metastatic disease. The Science article explores the potential mechanism of resistance in this same medulloblastoma patient. The authors found that a specific mutation in Smoothened (SMO) present in the tumor after relapse had no effect on Hedgehog signaling but did disrupt the ability of GDC-0449 to bind to SMO. Since SMO is the direct molecular target of GDC-0449, its inability to effectively bind to SMO in this patient likely led to the emergence of drug resistance. This work provides the first evidence that a family of receptors, of which SMO is included, may be subject to the development of drug resistance by mutation of a region of this receptor.

The National Cancer Institute’s (NCI) Division of Cancer Treatment and Diagnosis (DCTD) is currently sponsoring a Phase I clinical trial to evaluate dose and safety of GDC-0449 in medulloblastoma patients up to 21 years of age, as well as a Phase II trial in adult patients with medulloblastoma. Details for both trials are available at ClinicalTrials.gov.

Medulloblastoma is a malignant tumor of the cerebellum and is the most common brain malignancy in children, with a median age of diagnosis of 5 years and with incidence extending into young adulthood. As in advanced BCC, aberrant activation of the Hedgehog signaling pathway is strongly implicated in the development of some medulloblastomas.

About the Curis-Genentech Collaboration

Under Curis’ ongoing collaboration agreement with Genentech, a wholly-owned member of the Roche Group, Curis granted Genentech broad intellectual property rights relating to the Hedgehog pathway, including several classes of proprietary small molecule inhibitors. Through this collaboration, GDC-0449 was discovered by Genentech and was jointly validated by the parties through a series of preclinical studies. Genentech and Roche are responsible for the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449. GDC-0449 is currently being developed in three Phase II clinical trials by Genentech, including a pivotal trial in advanced basal cell carcinoma and Phase II trials in metastatic colorectal cancer and advanced ovarian cancer. Through a collaborative research and development agreement (CRADA) with NCI, the molecule is also being tested in medulloblastoma, small cell lung cancer and pancreatic cancer and is expected to be tested in additional NCI-sponsored trials in other indications in the future.

About Curis, Inc.

Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines for cancer indications. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis' website at www.curis.com.

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#68) On September 03, 2009 at 8:27 PM, portefeuille (99.75) wrote:

a "good day" for most players on the current "score points top20 list".

 

enlarge

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#69) On September 23, 2009 at 3:36 PM, portefeuille (99.75) wrote:

the presentation.

Oral vernakalant for the prevention of atrial fibrillation recurrence post-cardioversion

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#70) On September 23, 2009 at 3:40 PM, portefeuille (99.75) wrote:

that is the presentation Torp-Pedersen gave on 08/31/09 (see here).

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#71) On December 20, 2009 at 1:31 PM, portefeuille (99.75) wrote:

Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study

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