MY PICK IS ELN

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  • kingofthehill
    Senior Member
    • Nov 2003
    • 487

    Elan (Buy, Closing Price $12.70 ); Tysabri impacts the immune system - not new news
    Analyst: Ian Hunter T +353-1-6410498 E [email protected]

    Elan and Biogen Idec’s share prices fell yesterday as Teva circulated copies of a paper that University of Texas researchers propose to
    present at this year’s American Academy of Neurology meeting in April, that claims to show that Tysabri can deplete immune-system
    cells as much as HIV. The manuscript has been submitted to a scientific journal but ***has not yet been accepted***.

    No data are yet available
    as to: (i) which patient population this refers to; (ii) over what period of time the immuno-suppression was recorded; (iii) what percentage
    of the patients showed that strong degree of immuno-suppression; and (iv) how the depletion compares to other like-action drugs. As
    the action of Tysabri is, by nature, immuno-suppresive, some degree of depletion in immune system cells would be expected. Indeed,
    the effect of the drug on the immune system will have been one of the main factors studied in depth during the extensive safety review
    carried out on the 3,000 patients formerly on Tysabri and will be addressed during the Advisory Committee meeting. We remain
    comfortable that the drug will return to the market as more than just a second line treatment.
    Share trading to be suspended during Advisory Committee meeting on the 7 th and 8th of March
    In separate news, Elan announced last night that it has agreed with the Irish Stock Exchange, The UK Financial Services Authority and
    the New York Stock Exchange to suspend trading of its securities over the period that the FDA Advisory Committee is sitting to review
    Tysabri on 07 and 08 March. Biogen Idec had already announced similar action a couple of weeks ago.

    Comment

    • kingofthehill
      Senior Member
      • Nov 2003
      • 487

      Good detail on TEVA's repulsive behavior in this - Rx1

      Drug's approval dwarfed by worries over another
      By Penni Crabtree
      UNION-TRIBUNE STAFF WRITER
      March 1, 2006

      Shares of Biogen Idec fell about 6 percent yesterday despite the biotechnology company gaining regulatory approval for a new use for its top-selling cancer drug, Rituxan, as a treatment for rheumatoid arthritis.

      The additional approval for Rituxan – a drug developed by San Diego's former Idec Pharmaceuticals and co-marketed with South San Francisco's Genentech – was overshadowed by speculation about the fate of another Biogen Idec drug, the multiple sclerosis drug Tysabri. A key advisory committee of the Food and Drug Administration will deliberate next week about whether to recommend Tysabri's return to the market.

      The drug, co-marketed by Cambridge, Mass.-based Biogen Idec and Irish drugmaker Elan Corp., was withdrawn last year after it was linked to a rare but often fatal brain disorder called progressive multifocal leukoencephalopathy, or PML. The disease is caused by the activation of a virus that is commonly found in healthy adults but usually remains dormant; three patients who took Tysabri developed PML, and two of them died.

      A flurry of news – reports by wary Wall Street analysts that downplayed Tysabri's ultimate utility and a negative scientific paper on Tysabri circulated by a rival drug company – contributed yesterday to the companies' stumbling stocks.

      Shares of Elan, which like Biogen Idec maintains a research hub in San Diego, fell 9 percent, or $1.25, to close at $12.70. Biogen Idec's share price lost $2.85 to close at $47.25.

      A report yesterday by Piper Jaffray analysts speculated that Tysabri's use by physicians will be limited if the product returns to the market. A survey of 140 neurologists found that only 10 percent would prescribe Tysabri for their patients, and then only for those who fail other available treatments.

      A summary of a research paper, posted on the Web site of the American Academy of Neurology, concluded that Tysabri can deplete immune-system cells as much as HIV. PML typically afflicts AIDS patients because they have weakened immune systems.

      Tysabri's effect on the immune system might similarly increase patients' risk of contracting the PML-associated virus, the researchers said in the study. The study will be presented at the academy's annual meeting April 5 in San Diego.

      Teva Pharmaceutical Industries, the Israel-based maker of a rival multiple sclerosis drug, Copaxone, circulated copies of the abstract yesterday to the media through an outside spokesman. That action raised hackles at Elan, which is counting on Tysabri's return to shore up its fragile fortunes.

      “Other competitors will try to do everything they can to bring about criticism,” said Lars Ekman, head of research and development for Elan. “These are speculative exercises done by the competition, positioned and designed to undermine a new drug.”

      Biogen Idec spokeswoman Amy Brockelman said it would be “inappropriate” for the company to comment because of the American Academy of Neurology's policy to embargo the data until it is presented at the April 5 meeting.

      The risk of contracting the rare brain disorder can be managed by monitoring patients and not giving it to those with impaired immune systems, according to the companies.

      “This is an immunosuppressant drug and it suppresses the immune system,” said David Blaustein, who owns shares of Elan and manages health care investments at Suttonbrook Investments in New York. “It means the drug is working. It doesn't mean Tysabri equals AIDS.”

      CONTINUED

      Comment

      • skiracer
        Senior Member
        • Dec 2004
        • 6314

        Originally posted by spikefader
        ski, eekads man! Haste thou lost thou mind! lolol

        Seriously though, charts don't lie; only people do! And the chart was whispering what happened today for days......the TA has been pretty spot on for it recently....my entry the other day was pretty close to perfect dude; 1% risk and scooped 16%. Today's channel long with SHS was good for an intraday run (not that I saw the r/r value), and then the 12.88 resistance area was pretty good TA that had me +3% afterhours at one stage and open with green hope on it....

        Throw TA out the window!!!! I think not! hehe
        Sorry but I'm not buying into that Spike. But everyone's entitled to their own opinion and when I'm wrong I'm the first one to admit it. I've said it a number of times that what is driving this stock right now are the news breaks.
        I'm not saying the TA side doesn't have any merit right now. It always does. I just think the news is the main contributing factor presently. If you took a look at the 10 min. chart over the last 3/4 days the Parabolic SAR has been tracking bullish under the candles. But that drop yesterday was triggered by a newsbreak and nothing else. There's no way you could convince me of anything else. I thought it was a bargain yesterday at the low of the day around $12.20 to $12.50 and right now it's trading over $13.00 on 10 million shares. That's almost more than average daily volume before 12 pm.
        THE SKIRACER'S EDGE: MAKE THE EDGE IN YOUR FAVOR

        Comment

        • spikefader
          Senior Member
          • Apr 2004
          • 7175

          Originally posted by ski
          what's driving this stock is news....that drop yesterday was triggered by a newsbreak and nothing else.
          It's another interesting subject we've stumbled into ski, thanks. Prompted some thoughts that I'll share.

          Triggered is a good word. And yes, it makes logical sense that bad news SHOULD trigger people to sell...but logic isn't something you can count on from the market. It has insane and illogical moments.....like the times bad news gets bought or great news gets sold hard. Yep, your assumption that the bad news is the driver of this move or good news is the driver of upward moves would convince naive market participants and observers. But I don't see myself ever being convinced that a person is able to conclude with absolute certainty and correctness that a piece of news is the sole reponsible factor in stock price movement. I guess that's where my problem is with your argument ski. I agree news has a part to play, and one cannot discount it as a driver. But let's not discount the basic wonderful speculative fundamental principles that drive price too; support, resistance, and volume. Where do they fit in with recent ELN bearishness? Where do they fit in when trying to figure out what is driving a stock?

          Ski is saying the news is the main driver of failure of support and dropping price. Perhaps it was. Perhaps it wasn't. I wouldn't presume to know that.......and I don't think anyone can presume that....especially when we see good news get sold and bad news get bought.....

          Was the news being reflected in the chart before it hit the Street? Now that's a curious question. We know how humans work....I'm sure some people got wind of bad news before the public....perhaps the chart was merely reflecting those 'in-the-know' traders who were selling early......

          What I have said with confidence for a while now is that TA revealed the bias in a clear fashion, and the potential for support to fail was high. The channel short day resisted and sold, the symetrical triangle pattern targeted lower, the volume selling after pop was characteristic of a weak stock, the descending triangle provided the great r/r entry, the rising intraday wedge I charted, and it's breakdown, another price action that pointed lower......the bias has been clearly short for ELN lately. I think it's a mistake to ignore that stuff.

          My humble and friendly observation ski is that you are drawing a conclusion you aren't really in a position to conclude. I would never deny you the right to offer your opinion, and it's great that you do cuz it gets me thinking about truth in markets.....but false assumptions I will point out, for my own benefit and for anyone else reading.... Forget being wrong or right....and let's find the truth.

          And the truth as I see it is ELN could have easily rallied on bad news (how bad was it anyway? I dunno, FAers speak up please); and it would have rallied on mildly bad news and ignored it had ELN been a truly bullish stock at the moment....but it HASN'T been bullish, and bad news getting sold isn't surprising to me in the least, because yes, it helps to explain the move....
          But frankly there are many other forces going on behind the scenes that we DON'T know about that can be driving it....like perhaps funds need to exit large positions before the halting on the 7th......perhaps there was a fat fingers order entry error that led to the stops being taken out......perhaps a bunch of things. One cannot assume to KNOW it was news alone. News is clearly 1 driver of stocks.......but you can't assume to know which way it's gonna go.

          And thus it gets back to support is support until it isn't.

          Best to ya ski, thnx fer prompting the thoughts.

          Comment

          • skiracer
            Senior Member
            • Dec 2004
            • 6314

            If that newsbreak hadn't hit the wires yesterday I doubt that ELN would have fallen as hard as it did. I agree with your analysis from the daily and weekly charts that there was a genuine bearish short term bias. I firmly believe that news drives the markets and stocks to a pretty good degree but I'm in no way trying to put it above good old fashioned TA. From watching this stock over the last several months I have seen it rise and fall, but rise mostly, on positive news breaks. But I'm in no way saying that you're wrong in your views either. Dialogue an exchange of ideas is always good.
            THE SKIRACER'S EDGE: MAKE THE EDGE IN YOUR FAVOR

            Comment

            • Websman
              Senior Member
              • Apr 2004
              • 5545

              After careful consideration I changed my mind and held onto my ELN shares...good decision. It's good to see the truth coming out about Teva's dirty tricks.

              Comment

              • mrmarket
                Administrator
                • Sep 2003
                • 5971

                The Titans are considering throwing some sock drawer money into this for March 15 calls....

                If the drug wasn't going to be approved, why would they waste their time hearing it?? If I'm right...free money!
                =============================

                I am HUGE! Bring me your finest meats and cheeses.

                - $$$MR. MARKET$$$

                Comment

                • Websman
                  Senior Member
                  • Apr 2004
                  • 5545

                  Originally posted by mrmarket
                  The Titans are considering throwing some sock drawer money into this for March 15 calls....

                  If the drug wasn't going to be approved, why would they waste their time hearing it?? If I'm right...free money!
                  Good point. I may have to check into some calls myself. I'll use the profits to gamble with in Atlantic City.

                  Comment

                  • spikefader
                    Senior Member
                    • Apr 2004
                    • 7175

                    Originally posted by spikefader
                    Short 12.84 and I'll give it 4% risk for now.
                    Took my 4% hit on this short earlier today. Back to stalkin' the snake.

                    Comment

                    • Websman
                      Senior Member
                      • Apr 2004
                      • 5545

                      The drop in price is presenting a great buying opportunity. I may pick some more shares up in the morning.



                      Biogen, Elan's Tysabri Is Worth Rare, Fatal Risk, Patients Say

                      March 2 (Bloomberg) -- Michael Barron, a 48-year-old former operator of a nuclear power plant, was so crippled by relapses in his multiple sclerosis that he couldn't stand up without help. The drug Tysabri allowed him to take walks with his wife again.

                      Then a year ago, Biogen Idec Inc. and partner Elan Corp. suspended sales of Tysabri after just three months on the market because of a link to a fatal brain infection. Barron will travel across the U.S. next week from his home in Arizona to join other patients demanding that federal regulators allow sales to resume and let patients choose whether to risk the side effects.

                      ``I have friends in wheelchairs, using canes, committing suicide,'' Barron said in a Feb. 24 telephone interview. He plans to attend a Food and Drug Administration advisory panel meeting in Gaithersburg, Maryland. ``Most of us are pro-Tysabri because we failed all other therapies.''

                      The decision the FDA faces highlights the debate over patients' rights to a treatment with a severe side effect versus the agency's responsibility to protect them, said bioethicist Arthur Caplan. Study results suggesting Tysabri is twice as effective as other treatments made it the best hope for multiple sclerosis patients in 10 years and a potential $3 billion-a-year seller for Biogen and Elan.

                      The regulators ``pay more attention to safety than to efficacy, the desperation of patients or patients' right to bear the risk,'' said Caplan, a professor at the University of Pennsylvania in Philadelphia, in a Feb. 24 telephone interview. ``There is a certain amount of paternalism in public policy.''

                      The FDA's decision, due later this month, will hinge in part on recommendations from the panel of experts meeting March 7 and 8. The agency expanded the meeting to two days from one to allow enough time for public comment.

                      Testing Resumed

                      The agency on Feb. 15 cleared Cambridge, Massachusetts-based Biogen and Irish partner Elan to restart testing of Tysabri in patients for the first time since sales stopped. That raised hopes the agency may allow marketing to resume.

                      Deborah Knobelman, an analyst with Piper Jaffray & Co. in New York, said in a Feb. 28 note to clients that she expects the FDA to either approve Tysabri for limited use only or agree to approve it pending the completion of the resumed safety trials. She based her prediction on a survey of 140 neurologists that found 57 percent said Tysabri's efficacy is worth the risk of developing the brain infection only for patients who failed other MS therapies.

                      Caplan predicts the advisory panel will vote against Tysabri's return because ``there is no easy way to control the risk.''

                      The panel of experts will focus on whether Tysabri's benefits outweigh its risks and, if so, whether the drug's side effects can be managed. The committee also will consider what restrictions should be placed on Tysabri's use if sales resume.

                      2.5 Million Affected

                      Biogen and Elan introduced Tysabri in November 2004 to treat a neurological disorder that erodes muscle coordination and balance, sometimes leading to damaged vision and paralysis. Multiple sclerosis affects about 2.5 million people worldwide. Severe cases result in permanent disability, including partial or complete paralysis.

                      Tysabri, given as a once-a-month intravenous infusion, was the most expensive multiple-sclerosis therapy on the market, costing about $23,000 a year.

                      About 8,000 patients took the drug, including participants in clinical trials, by the time the companies voluntarily suspended sales on Feb. 28 last year. Biogen and Elan said the decision was based on one fatal case of the brain infection, called progressive multifocal leukoencephalopathy, in people taking Tysabri and a suspected second case.

                      The companies' shares plummeted that day, wiping out about $17.8 billion of combined market value.

                      Share Price

                      Biogen's shares declined 30 cents to $46.95 yesterday in Nasdaq Stock Market composite trading. Elan fell 39 cents, or 3.5 percent, to $10.80 in Dublin.

                      A study by University of Texas neurologists, posted in summary form on a conference Web site this week, suggested Tysabri can deplete the immune system as much as HIV. Tysabri works against multiple sclerosis by suppressing immune-system cells. The same effect may raise the risk of complications such as the PML infection.

                      A safety review by the companies last year ultimately concluded that three people had contracted PML and two died. No test exists for PML. The risk of contracting it is about 1 in 1,000, according to a study released yesterday by the New England Journal of Medicine.

                      Patients Group

                      ``There is no such thing as a perfect drug,'' said Barron, who founded MSpatientsforchoice.org to argue that the decision on whether to take the risk should be left to patients and their doctors. ``This drug is the closest thing there is to a cure for MS.''

                      Barron says his group, which is paying travel expenses for about 10 MS patients, holds fundraisers and takes no money from Biogen, Elan or other pharmaceutical companies.

                      A survey of 800 MS patients released this week by the National Multiple Sclerosis Society and Harris Poll found most would consider using Tysabri under certain conditions, such as if their current treatment wasn't working or a reliable test existed for PML. The Society plans to release detailed results after the FDA advisory panel's meeting.

                      The companies say Tysabri should be cleared again because the treatment reduces multiple sclerosis relapses by more than two-thirds and delays disability. Current therapies, such as Biogen's Avonex, reduce relapses by one-third, studies showed.

                      Risks

                      The risks can be managed, partly by advising patients with impaired immune systems not to take the drug, said Biogen's Burt Adelman, the executive vice president in charge of medical research and regulatory affairs, in a Feb. 9 interview.

                      Tysabri also shouldn't be taken in combination with other MS therapies, Adelman said. In two of the reported PML cases, the patients were taking Tysabri in combination with Biogen's Avonex, a multiple sclerosis drug introduced in 1996.

                      PML occurs when an infection called the JC virus evades the body's immune defenses and penetrates the central nervous system. There it eats away the protective coating of nerve fibers, called myelin, causing irreversible brain damage.

                      Multiple sclerosis is caused when an abnormal immune-system response attacks the myelin. Tysabri, an antibody-based medicine, was designed to prevent that assault by suppressing immune cells. Researchers theorize that Tysabri may subdue defenses meant to keep the JC virus out of the brain.

                      It's a risk that Cheryl Bloom is willing to take. A 53-year- old landscape designer in Eagle, Idaho, who was diagnosed with MS in 2001, Bloom says she's paying her own expenses to attend the FDA advisory panel meeting next week.

                      ``This drug worked for me, and I want to be able to have the choice to make an informed decision,'' Bloom said. ``There are risks in every drug.''




                      To contact the reporter on this story:Angela Zimm in Boston at [email protected]

                      Comment

                      • noshadyldy
                        Senior Member
                        • Sep 2003
                        • 539

                        pause (paws) for a moment of levity

                        Where do pets come from?


                        A newly discovered chapter in the Book of Genesis has provided the answer to "Where do pets come from?"

                        Adam and Eve said, "Lord, when we were in the garden, you walked with us every day. Now we do not see you any more. We are lonesome here, and it is difficult for us to remember how much you love us."

                        And God said, I will create a companion for you that will be with you and who will be a reflection of my love for you, so that you will love me even when you cannot see me. Regardless of how selfish or childish or unlovable you may be, this new companion will accept you as you are and will love you as I do, in spite of yourselves."

                        And God created a new animal to be a companion for Adam and Eve.

                        And it was a good animal.

                        And God was pleased.

                        And the new animal was pleased to be with Adam and Eve and he wagged his tail.

                        And Adam said, "Lord, I have already named all the animals in the Kingdom and I cannot think of a name for this new animal."

                        And God said, " I have created this new animal to be a reflection of my love for you, his name will be a reflection of my own name, and you will call him
                        DOG."

                        [img]aoladp://MA12666412-0001/wheredop.gif[/img]
                        And Dog lived with Adam and Eve and was a companion to them and loved them.

                        And they were comforted.

                        And God was pleased.

                        And Dog was content and wagged his tail.

                        [img]aoladp://MA12666412-0002/file000.gif[/img]
                        After a while, it came to pass that an angel came to the Lord and said, "Lord, Adam and Eve have become filled with pride. They strut and preen like peacocks and they believe they are worthy of adoration. Dog has indeed taught them that they are loved, but perhaps too well."

                        And God said, I will create for them a companion who will be with them and who will see them as they are. The companion will remind them of their limitations, so they will know that they are not always worthy of adoration."

                        And God created CAT to be a companion to Adam and Eve.

                        [img]aoladp://MA12666412-0003/file001.gif[/img]

                        And Cat would not obey them. And when Adam and Eve gazed into Cat's eyes, they were reminded that they were not the supreme beings.
                        [img]aoladp://MA12666412-0004/file002.gif[/img]
                        And Adam and Eve learned humility.

                        And they were greatly improved.

                        [img]aoladp://MA12666412-0005/file003.gif[/img]
                        And God was pleased.

                        And Dog was happy.

                        [img]aoladp://MA12666412-0006/file004.gif[/img]
                        And Cat didn't give a shit one way or the other.

                        [img]aoladp://MA12666412-0007/file005.gif[/img]


                        "Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." Goethe

                        Comment

                        • skiracer
                          Senior Member
                          • Dec 2004
                          • 6314

                          I love cats. We lost our last one awhile back and my wife just isn't ready for another one yet. But she is softening up an I can't see it being to much longer. I can't wait. Nothing like a little kitten running around the house.
                          THE SKIRACER'S EDGE: MAKE THE EDGE IN YOUR FAVOR

                          Comment

                          • Websman
                            Senior Member
                            • Apr 2004
                            • 5545

                            My dog had a cat cornered in the back yard late last night. At first I thought she might have had an alligator cornered, so I grabbed my rifle. It was dark and I couldn't really see much...I had the gun cocked and ready to fire, until he jumped the fence. That's when I realized it wasn't a gator...of course, I've seen some alligators that are 8 feet long in our lake, so if it would have been a gator it wouldn't have been good...jejeje

                            Comment

                            • noshadyldy
                              Senior Member
                              • Sep 2003
                              • 539

                              I hope you do have another little one soon, SKI. I just love them too.
                              Although I must say, none of mine were ever aloof like the stereotypical cat is portrayed. Mine have all been love bugs from the very start, or soon turned into them. Even the ones that never knew a home before. I remember when I got Black Jack. He didn't quite "get" the human relationship thing. He was sweet and went along with it as best he could, but you could tell he wasn't quite comfortable with it. He actually looked puzzled by it. Afterall, didn't humans treat cats mean? They certainly never cared for him, never gave him a home or loved him. When I adopted him from the pound (estimated to be only a year old and listed as a stray) he was very very sick, had given up, and was just lying there in his cage on his side. Well, a couple of trips to the vet, and lots of lovin and he is just "the cats meow", big and beautiful! And as for the not knowing what to do with that human relationship thing, he's been one of my best cat students yet, and has mastered it magnificently. He's my love and he knows it. He's proud and happy now, and INCREDIBLY affectionate. Just like I like 'em.
                              Give your wife my warmest regarding the hurt she carries. It will always be there to some extent, you will always miss the ones that have passed over, but there are so many more that need to be loved. And I can smell a big heart clear across the country, SKI. You and your wife will make some lucky cat very very happy.

                              And for those of you who are getting annoyed at my babbling about cats, as my sainted Polish grammy would say, "tough shitzki!"
                              "Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." Goethe

                              Comment

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