Tweet
Originally posted by noshadyldy
the stock is a buy it will be $12.00 before long ..and could finish the year at $15.00...end of next year conservative view this is a $25.00 stock
-
there was a power struggle after the stock fell Garo Armen ( the guy who sold) Elan CBO, in March 2005 wanted to break the company up he lost his bid to take out Kelly Martin . he is bitter that he lost as he was the guy who hired kelly martin .. the good news is Garo still owns options on 800,000 shares of elan so he sold some of the stock ...but still has plenty of stock at 4.72 per share.
the stock is a buy it will be $12.00 before long ..and could finish the year at $15.00...end of next year conservative view this is a $25.00 stock -
go ELN!
ELN seems to be taking off today. Your $12 near-term target may be right around the corner. I think rumors of good patient data from the T trials may be going around. Won't make me buy, though. I had my chance at $3.5 and blew it.Comment
-
The big boys will knock it down tomorrow with all kinds of bad news. It may give another buying opportunity.Originally posted by jiesenComment
-
Irish Times Interview: Wyeth CEO
Extract from today's IT:
"On drug development, he is bullish about a joint venture with Irish drug company Elan that is trying to develop a treatment for Alzheimer's disease.
'That partnership has produced what are the most promising potential therapies for Alzheimer's' he says.
'Alzheimer's is something you don't make too many predictions about. It's been a tough area to be successful in but, if I stack our joint venture with Elan against anything else in development, I'd say we're ahead'."Comment
-
Health Tue, Sep 13, 05
When a trial drug is withdrawn patients can pay a high price
Strict rules govern how firms test new treatments but withdrawing a drug can have adverse effects for patients trialing them, writes Dominic Coyle
Clinical trials are always a risk, both for patients and for the companies trying to prove the efficacy of their products.
From the company's perspective, trials can throw up all sorts of unexpected results despite the best research and preparation. Adverse results can be catastrophic for businesses whose shareholders and other financial backers invest largely on the basis of drug pipelines and the prospects of future sales success.
For the patient, the situation is even more critical. Most are seriously unwell in the first place, sick enough to take the risk of being dosed with an experimental drug that may prove beneficial but, then again, might not.
Ann (not her real name) has been battling with multiple sclerosis (MS) since her early 30s. As the condition progressed, she found her declining mobility made her more dependent on her husband and family. Worse still, for a woman who worked with her hands, she found herself suffering from diminishing sensation in her hands and feet.
When Elan Pharmaceuticals and Biogen Idec began clinical trials for Tysabri, then called Antegren, her neurologist put her name forward. Apart from the MS, Ann was young, healthy and had a clean medical history in that she had not been taking a series of medicines that might contaminate the trial.
"I enrolled in trials because I thought it mattered a lot, I thought, maybe, one person might not have to wake up every day, lying very still, taking mental inventory of fingers and toes before daring to move as a result of the decisions of myself and others to take part in the trial and that would have made it all worthwhile."
Ann was lucky initially. The experimental drug was designed to slow down the progression of her disease, not reverse its physical symptoms.
"I certainly did not expect to find a miracle, just a small step to help those walking behind me would have been enough. I'd have been happy with that. But it was a miracle, from my point of view, I was so alive. I was healthy and strong and so happy."
From a position where her mobility was borderline, Ann had almost fully recovered from the physical symptoms of her condition.
Ann spent three years on the trials and, as a result of her positive experience and that of the trial patients in general, Tysabri won fast-track approval from the US regulator, the Food and Drug Administration (FDA), for sale on the open market late last year.
Then, in February, disaster struck. Follow-up studies indicated that two people in a trial of the drug along with an existing Biogen MS treatment, Avonex, had contracted a rare and potentially fatal brain disease, progressive multifocal leukoencephalopathy (PML). One died.
The drug was withdrawn and one subsequent case of PML emerged in a trawl of existing patient data.
All three cases of PML involved people who had been taking a range of other drugs including immunosuppressants and steroids.
"I was gutted," says Ann, who was on the trial using Antegren/Tysabri on its own. No one on that MS trial has shown signs of PML. "Going into the trials, the most important thing for me was to never compromise them in any way, not even a sip of beer. That's why I am so disappointed that so many very sick people were in trials and that spelled a horrible verdict for a very good drug."
Six months down the line, Ann is now confined to a wheelchair and losing her sight. She is angry at losing the gains she had made and desperate to see Tysabri back on the market.
"I understand the importance of safety and the need for the companies and the regulator to be careful. But the fact is that the one thing that was allowing me to live with dignity has been taken away from me.
"I would sign any consent form to enable me to access Tysabri again. People need to understand how important trials are to those of us who find ourselves in this position," says Ann.
Elan and Biogen are currently talking to the FDA about bringing Tysabri back to market.
© The Irish Times Sept 13th 2005Comment
-
We have news!!! Hahaha!!! Yeah!!!
This is just the beginning of a fun ride!!!
Comment
-
Stocks to Watch Wednesday
--------------------------------------------------------------------------------
Midnight Trader
7:33 p.m. 09/20/2005
Boston, Sep 20, 2005 (MidnightTrader via COMTEX) -- Elan (ELN) was up 2.1% (at 8.49) and Biogen Idec (BIIB) was adding 1.6% (at 40.89) late Tuesday night after the companies reported that the safety evaluation of Tysabri, a treatment for Crohn's disease and rheumatoid arthritis, should be completed within the coming weeks, and that they will submit a supplemental Biologics License Application for Tysabri in multiple sclerosis to the FDA.
ELN spiked from 8.31 straight to its after-hours high of 9.03 following the report. This top faded quickly, and ELN slid back through the 8.75 level to an early evening low 8.34. It recovered to hold a narrower upside range between 8.35 and 8.53 through the mid-session and second-half of night trade.
After-hours indications would suggest a potential premarket open on Wednesday surrounding the 8.40 level.
We've found that following Tysabri-related news events ELN tends to react to these announcements with the most volatility while BIIB has demonstrated some consistency in sticking tight to its after-hours percentage movement in next-day trade. With the expectation of more volatility in ELN we would look for early long opportunities in the stock on on Wednesday, targeting entry points near the 8.31 to 8.40 level - a range that saw some of the strongest upside liquidity throughout tonight's session.
BIIB jumped from 40.24 and immediately sought out its early evening high of 42. Sellers moved aggressively into the stock off this top, dropping it hard from 41.90 to 40.35. It settled between 40.41 and 40.80 into the mid-session and second-half of the evening. Of note for traders was the distinct lack of liquidity through the latter part of the session, making the late range somewhat less dependable.
A pre-market open on Wednesday looks to have some potential at 40.40 or above.
As we stated in our ELN assessment, we've found the historical performance for BIIB on Tysabri-related news to hold a decent level of consistency, sticking tight to its after-hours percentage movement in next-day trade. The stock's limited historical range in either direction would have us looking close to the flatline for long entry targets, hugging the 40.24 to 40.41 levels.Comment
-
Time to Bring Back a Miracle Drug
Michael Fumento (archive)
September 22, 2005
The makers of the multiple sclerosis drug Tysabri have just announced they will seek Food and Drug Administration approval to resume sales of the drug. I don’t have MS, but I couldn’t be happier.Since April, when I wrote about the biotech drug’s sudden withdrawal two months earlier, I’ve been deluged with heart-rending e-mails from people begging me to do more to help bring it back. Despite readily qualifying as a “miracle drug,” it got the yank (possibly under FDA pressure) because three users had developed an often-fatal neurological condition.
“Please see what you can do to persuade the FDA to do something for Tysabri's speedy return,” pleaded one. “I don't think I can hold out much longer. Nothing else is stopping my attacks, or the progression of my MS. Haven't I suffered long enough (29 years)?”
Said another, “For those who suffer from MS [the drug’s withdrawal] is more then a travesty, it is the abduction of hope itself. My niece, age 25 has MS. She had hoped Tysabri would give her life back. That she might marry, have a family, and be happy. Her story is duplicated 400,000 times.” That’s about the number of Americans with MS.
Tysabri, jointly produced by Biogen Idec and Elan Pharmaceuticals, is incredibly effective against MS, a disease that attacks both the brain and spinal cord and can cause a host of symptoms including paralysis, blindness, fatigue, and sometimes death. There are other MS drugs, but none appear to be nearly as powerful or as well-tolerated as Tysabri. Results from two years of clinical trials showed a stunning 42% reduction in the risk of disability progression and an even more striking 67% reduction in clinical relapses.
In late clinical trials Tysabri has also apparently been extremely effective against Crohn's disease, a severe bowel disorder, and it was in human testing for rheumatoid arthritis. But these trials were also halted. Doctors told me their patients loved Tysabri not just because it was so effective but because the side effects were so mild. So it came as a stunning blow to the approximately 8,000 using the drug, as well as a long list of persons waiting to get prescriptions, when the axe fell.
The neurological disorder linked to Tysabri, progressive multifocal leukoencephalopathy (PML), is caused by a common virus that the immune system usually keeps under lock and key. But in all three known cases among Tysabri users it was being tested in combination with another drug. Both are immunosupressants and apparently the combination allowed the virus to flourish. Nevertheless, there are NO known cases of PML in patients using only Tysabri, according to the FDA.
Tysabri’s makers have now screened the entire database of more than 2,000 MS patients and are finishing a similar review of about 1,500 people from the Crohn’s and arthritis trials. They’ve found no new PML cases.
It appears Tysabri would simply be on the huge list of both prescription and over-the-counter (OTC) drugs that have serious interactions with other drugs. The FDA also allows continued sale of countless drugs that when used alone kill thousands of Americans each year, such as aspirin and Tylenol. Why? Because the benefits are so huge. For that matter, there’s been no withdrawal of an MS called Novantrone that causes such serious side effects as fatal congestive heart failure and leukemia.
Likewise, all the drugs that slow the development of rheumatoid arthritis carry FDA warning labels and some may cause death. Yet arthritis sufferers practically worship them.
There’s a simple way of dealing with vital drugs that nonetheless may cause serious harm. It’s a warning label made especially conspicuous by placing it inside a “black box.” Tysabri’s makers have already said that if the drug is reintroduced they want it black-boxed.
I use a black-boxed drug (implicated in liver failure deaths) and thank God it just tagged rather than being yanked as a “consumer protection” group had demanded. (It falsely claimed other drugs were just as effective and well-tolerated.) Otherwise I might be as desperate as those poor MS sufferers who were shown a glimpse of normal life only to have it brutally ripped away. They, too, deserve access to the best medicine available.
<EM>Michael Fumento ( mfumento at pobox.com ) is a senior fellow at Hudson Institute inComment
-
From Forbes.com by Peter Kang, 09.26.05, 6:06 PM ET
"
NEW YORK - As expected, Biogen Idec (nasdaq: BIIB - news - people ) and Elan (nyse: ELN - news - people ) filed for U.S. Food and Drug Administration approval of multiple sclerosis drug Tysabri, the drug companies announced after the closing bell. Last week, the companies said they expected to file for FDA approval but did not provide specific timing. Tysabri was pulled from the market last February. Shares of Biogen rose 2% in the after-hours session, while Elan gained about 1.5%. Piper Jaffray maintained a "market perform" rating on Biogen last week. "While we remain optimistic that Tysabri will eventually return to market, our recent discussions with clinicians make us less optimistic that this will occur prior to completion of additional trials," said Piper Jaffray. "At a minimum, even if the FDA does clear Tysabri for marketing, we would expect very limited use until more data is provided regarding the risk management of PML [progressive multifocal leukoencephalopathy]."
"Comment
-
Mono-Therapy Will Double Elan
Ken Kam, 09.28.05, 6:00 AM ET
The single biggest issue that is significant enough to drive a double in Elan over the next two to three years is this: Will the FDA approve Tysabri for use in mono-therapy after Elan pulled it from the market?
Click here for "Five Oil Plays Still At Bargain Prices," a special report from Marketocracy's Marketscope.
We surveyed more than 1,500 members of Marketocracy who put Elan (nyse: ELN - news - people ) in their virtual portfolios to try to flesh out the answer. Three interesting perspectives emerged from the responses.
The FDA: For the U.S. Food and Drug Administration, the question of whether to allow Tysabri back on the market is one of benefits and risks. The main benefit is that two-year clinical studies have shown Tysabri, when used alone, is twice as effective as any other approved drug in preventing relapses. People who have used Tysabri have actually got out of their wheelchairs.
The main risk is that three patients have come down with a potentially fatal complication called progressive multifocal leukoencephalopathy, or PML--two have died. That's a complication rate of 0.1% out of 3,500 patients. All three cases involve patients taking Tysabri in combination with Avonex from Biogen (nasdaq: BGEN - news - people ). Since the three PML cases were discovered, 91% of the patients in Multiple Sclerosis clinical trials that took Tysabri have been screened for PML, and no additional patients have showed signs of contracting it. There has not been a single case of PML when Tysabri was used alone, but Elan voluntarily took it off the market.
Special Offer: Two of the hottest sectors of the market? Gold and energy. Click here to download "Oil and Gold: Slam Dunk Investing for Income and Capital Gains," an updated, free special report from Professional Timing Service.
The bottom line is the drug sets the gold standard for efficacy in a disease that is very nasty. Patients want this drug available because it is effective. I expect the FDA will decide that its benefits offset its risks--especially for patients for whom all existing drugs have failed.
Patients, Doctors and Caregivers: MS patients and the people who care for them understand that treating powerful diseases requires commensurately powerful drugs, and they understand that, because of potency, the drugs have potentially fatal consequences for some at-risk patients.
For almost 25% of MS patients, existing drugs have failed to be effective, so many have stopped taking any MS drug at all. Tysabri could be their best option. Most of the remaining MS patients report that the drugs they take do not work well. At best, they slow the progression of the disease, but there is a high relapse rate and many side effects.
So, given the almost 100% certainty of the progressive debilitating effects of the disease, most patients would opt for the rare possibility of PML if they could halt the progress of MS and improve the quality of their lives. A particularly poignant response I received was: "I participated in the AFFIRM trials and had Tysabri for nearly three years. I forgot what it was like to be an "MSer." Since Feb. 28, nearly all of my most annoying symptoms (itching, fatigue, brain fog) have returned, and I have had my first relapse in about four years."
Special Offer: Since its inception in April 2005, Mentley's Display Technology Investor model portfolio has climbed 40% compared to 6% for the Nasdaq. For "Three Stocks Ready to Ride the Big-Screen TV Boom," click here.
Biogen: Biogen, the U.S. distributor for Tysabri, also owns a best-selling MS drug called Avonex. Typically, a drug has to be proved effective as mono-therapy before it is approved for combination therapy. Biogen pushed Tysabri's use in combination with Avonex, hoping to convince doctors to prescribe two drugs instead of one. Taking on Biogen as a partner created a conflict of interest.
With FDA approval of Tysabri in combination with Avonex looking remote, Biogen's next-best alternative is to return Tysabri to the market as quickly as possible. As a result, Biogen's interests are now much more aligned with Elan's.
Approval by the FDA of Tysabri for use in mono-therapy by the 20% to 25% of MS patients that have already given up on all other drugs would drive a double in Elan's stock price. Based on the feedback we've received from the people who are in the best position to judge, we believe that will happen. And if any of the remaining MS patients decide to give up on the less-effective drugs they are currently using to try Tysabri then Elan will do even better.
Excerpted from the September 2005 edition of Marketocracy's Marketscope. Click here for more.
More Adviser Soapbox columns
Send comments and questions to [email protected]Comment
-
looking better close 8.81Comment
-
Profits are on the way...Originally posted by kingofthehillComment
-
Spike what do you see for ELN ?Comment
-
Patience...patience...Comment
-
I see a triple top on the 6mth daily is what I see. And it's sitting right at the neck of a pretty good looking SHS (the head isn't higher than the L shoulder of course). If the neckline breaks, that is fuel to push it down to 6.00 and under all that nice vol by price that's been building. Money flow is bad and pops have been sold. I am bearish on it.Originally posted by kingofthehill
I'll do a full chart later, I'm walkin' out the door.Comment
Comment