I wonder if any gamblers noticed my post 334 on the GMC thread yesterday.
It looks as though bottom fishing can sometimes pay off.

frustrating news this morning...only a tempoary set back I hope, this story from bloomberg....

Elan Says U.S. Regulator Delays Tysabri for 90 Days (Update3)
March 22 (Bloomberg) -- Elan Corp. and Biogen Idec Inc. said U.S. regulators delayed the possible return of the multiple sclerosis drug Tysabri to review the companies' plan to prevent a rare side effect that killed two patients.

The Food and Drug Administration's decision on Tysabri, which was expected by March 29, will now be delayed by as much as 90 days, Dublin-based Elan said in a statement today. Elan and Cambridge, Massachusetts-based Biogen have proposed strong warnings for patients and controlled administration of the drug.

Shares of Elan, Ireland's biggest drugmaker, fell as much as 11 percent, the most in eight months. Tysabri was withdrawn more than a year ago after two patients died from a rare brain infection. Some analysts expect Tysabri to reach annual sales of more than $3 billion if the safety concerns don't cause the FDA to restrict access to the product.

``From here, it is unclear if it will take weeks or the three months for the FDA to agree on an acceptable risk management plan,'' Orla Hartford, analyst at Dublin-based NCB Stockbrokers said. ``We believe that use of Tysabri could be limited for at least three months post re-launch as infusion centers will need to be registered prior to administration.''

Hartford, who has a ``buy'' rating on the stock, has reduced 2006 forecasts in the U.S. to $20 million from $116 million. Her peak sales forecast of $1.8 billion is unchanged.

Shares of Elan fell as much as 1.38 euros, and declined 98 cents, or 8.1 percent, to 11.20 euros at 9:39 a.m. in Dublin. Biogen shares declined 1.32 euros to 39.20 euros ($47.36) after closing at $48.31 yesterday in New York.

Patient Deaths

Tysabri sales were halted on Feb. 28, 2005, on the first reported death from an infection called progressive multifocal leukoencephalopathy, or PML. The recall wiped out $17.8 billion in combined market value for Biogen and Elan that day. More extensive reviews revealed that two patients died and a third developed PML and survived.

The Elan and Biogen product had been seen as the best hope in a decade for the world's 2.5 million MS patients. MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis.

The companies re-submitted the product to the FDA and patients appealed to an agency panel of doctors and scientists earlier this month to permit its reintroduction. The advisory panel voted unanimously on March 9 to support a plan to resume sales for all patients. The FDA usually follows the committee's recommendations.

Tysabri would be only the second drug put back on the U.S. market following a safety-related suspension.

Safety Plan

Elan and Biogen's safety plan for Tysabri includes administering the treatment at registered infusion centers and a requirement that all patients sign a consent form saying they have been advised of the product's risks. The medicine's prescribing information should include the FDA's strictest warning, outlined in a black box, that Tysabri is associated with an increased risk of PML, Biogen said on March 8.

Doctors will be told to suspend treatment if patients show signs of the disease and they should test for PML.

``It's a blow for the stock,'' said Ian Hunter, an analyst at Goodbody Stockbrokers with a `buy'' rating on the shares. He said the delay will mean a ``better thought through risk- management plan for Tysabri and a quicker launch after its approval in June.''

The timing of Tysabri's introduction depends on how quickly the company and regulators can complete a program to manage the risk of PML, Biogen Chief Executive Officer James Mullen said after the advisory panel's decision to back the drug. He said the companies planned to re-introduce the medicine by June.

Tysabri may be used by as many as 100,000 U.S. patients who weren't helped by or stopped taking MS drugs, Mullen said earlier this month. He declined to discuss pricing. Tysabri, given as a monthly infusion, was the most expensive MS drug at $23,500 before the withdrawal.



To contact the reporter on this story:
Etain Lavelle in London at at elavelle1@bloomberg.net.
Last Updated: March 22, 2006 05:19 EST

just means june/july is extra big month for Elan.

Like you say Crippy, a temporary set back. I am feeling confident for the long term, and the decision could come any time in that 90 day period. The price could dip further this afternoon once the US opens.

encouraging news late tonight....

Biogen, Elan retest MS drug, see FDA action by June
Thu Mar 30, 2006 2:40 AM GMT
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CHICAGO (Reuters) - Biogen Idec and Elan Corp said on Wednesday they have restarted a safety trial of its multiple sclerosis drug Tysabri, which the drugmakers recalled from the market after reports of rare brain infection were linked to the drug.

A U.S. Food and Drug Administration panel earlier this month recommended the drug be returned to the market, with mandatory controls for risks and new cases of the fatal side effect, linked to two deaths.

The companies expect an action by the FDA by June 28, 2006.

elan closed up late in new york....yippee

Glad I bought some more last week.

Sounds like a good addition frampton, recent activities just go to show the jittery nature of the stock, especially as regards reaction to positive and negative news. I tend to think there maybe more of these fluctuations before we get some firm facts on the conditions of a relaunch. But there will no doubt be negative press from rival drug companies, which may result in a dip in price, but the future will be all good. I especially liked the goodbody analyst who put a target price on elan @ $68! which is why i may still add a few more perhaps at the point of any dip in price.

Spoke to the doctor incharge of the tysabri trials in which i was participating this afternoon in an attempt to gain verifification of the resarting of the trials, and was told that the hospital neurology dept is awaiting green light for restart and the protocols under which they are to be conducted. so you can gaurantee that when they call me with an update then I will post here any info I am told. hope this will be soon, and when they restart i will know the full story on what if any restrictions will be put on the use of the drug. i fully expect to have this info within the next month, so I guess any limitations put on the trial and those eligable to participate will be similar if not the same as the limitations put on the drugs use when relicenced. So when I knw this thread will know.

Crippy, I think you're right - this will be very volatile until we know the facts, if I have spare cash and there are any big dips I will be topping up as i'm feeling pretty confident in the long term future, and as you've pointed out before, it's not all about Tysabri, (although current share price movements are). I look forward to finding out what your doctor has to say about restarting trials.
Frampton

found an interesting piece on elan at 'fool' quite a good read....

POST OF THE DAY
Elan Corp., plc

Expectations

Discussion Boards
This Post In:
Elan Corp., plc

By TMFBreakerTinker
March 31, 2006

Posts selected for this feature rarely stand alone. They are usually a part of an ongoing thread, and are out of context when presented here. The material should be read in that light. How are these posts selected? Click here to find out and nominate a post yourself!


Just to put it all in perspective, and yes the FDA delay sucks, but so be it. A lot of things suck and we go on (well not if you have MS and need the best medication available, but not going there). As an investor here are expectations.

To justify the present market cap of ELAN excluding the rest of the business which I've assumed will be EBITDA break even, with $125 million in annual interest payments and $300 million joint expenses on Tysabri, using only U.S. market of 400,000 potential patients, what Tysabri needs to do is reach 10-13% market share. Somewhere between 45-50,000 patients. I did up the price of Tysabri slightly to $24K, which is probably conservative. I did use 75% gross margin, did not include any tax as I believe there will be massive tax loss carry forwards, but otherwise Irish corporate tax is around 12.5%.

What I get to justify the present market cap of $6 billion, utilizing cash flow is between 47,000 and 53,000 patients, depending if the market gives ELAN a 30 or 40 multiple. Using a 400,000 patient addressable market we get 11-14% market share to justify the present market cap.

Is anyone here not comfortable with meeting an 11-14% market share for Tysabri? Plus, given the fixed cost nature of the marketing share and of the interest payments, the higher [the] market share, the disproportionately higher will be the profits.

There can be no assurance at all that Tysabri will even have even 5% market share. We've seen a recent peak Tysabri estimate by one of the brokerages of around $250 million or 2.6% market share; i.e., mere guinea pigs utilizing this drug that is 2x as effective as anything else on the market and likely to be on the market for at least 3-4 years. So people with MBA degrees do differ. Whether it is an honest difference or an influenced by investment banking relationship business who can say, but the difference is there. So there is no certainty, well except for Tysabri coming back to market.

All this said, absent some shocking and egregious restriction placed on Tysabri, it seems to me that on Tysabri alone, excluding all else, using cash flow metrics and a 30-40 multiple thereon, which although high in many respects is not in this field of company and product what Tysabri needs to achieve to not lose us money is 11-14% market share. Exceeding this market share should, should as again no certainty in anything we do here, but mathematically, lead to stock appreciation in excess of $1 to $1 given the fixed fee nature of the expenses to be incurred by ELAN.

If stock picking were as easy as just running numbers everyone would be rich. But I have found that understanding what is valued in your stock greatly reduces your risk. I don't like to lose money and therefore don't like to buy a stock whose stock price poses me great risk of loss even if the company executes. Herein, are what I believe are Tysabri expectations, 11-14% market share which equates to $1.113 to $1.266 billion in Tysabri sales.

Take or leave the hard-core numbers and decide for yourselves if there are better places to put your money on a risk/reward basis. I have personally found another biotech with even lower expectations versus its market potential with an approved drug just now on the market (it is a Rule Breaker stock so I will discuss that one on the Rule Breaker side of these boards) but I cannot say that I feel uncomfortable at all at this time, at this valuation, with ELAN based upon this analysis.

There is still a risk that the FDA restricts Tysabri to second tier. That would be a mistake and an overreaction, and I don't care if I'm a M.D. or not it would simply not be in the public interest to do so. But the chance exists. Nevertheless, Tysabri is going to exceed 11-14% market share I do believe, in fact I believe it will eventually be the #1 MS drug on the market which presently is $1.6 billion per annum with Avonex. Avonex is less expensive, less effective, more painful to administer, but at least better than Copaxone and Rebif in that regard as it is only a once a week injection. Further I do believe that Tysabri expands the market, further I do believe that Tysabri will have very material sales in Europe, and there are no European figures in these totals.

Kool-Aid alert again always appreciated as I feel compelled to redundantly run these sorts of numbers every few weeks until fruition.

Tinker

Think it covers most things quite nicely really....crippy

the trend continued upwards today despite the the anual reports mixed company messages which is I feel a good omen for the coming weks....interesting methinks

a little light reading on the subject of VLA-4 inhibitors....

The Problems Associated With Natalizumab, Coupled With the Withdrawal of the COX-2 Inhibitors in Lat
Apr 06, 06:09 AM


Research and Markets (http://www.researchandmarkets.com/reports/c31740) has announced the addition of the Decision Resources report "Future of VLA-4 Antagonist Drugs and Implications for the Regulatory Process" to their offering.

In March 2005, in response to the development of three cases of a rare opportunistic infection in patients taking Biogen Idec and Elans monoclonal antibody (MAb) natalizumab (Tysabri), the FDA decided to place a clinical hold on another VLA-4 drug in clinical trials, and a second company voluntarily withdrew its VLA-4 drug from development while an investigation on the safety of this drug class is conducted. These safety concerns have affected several drugs in development for treatment of multiple sclerosis (MS), Crohns disease (CD), asthma, and other indications. Given the need for more-efficacious treatments to slow the progression of MS, will the FDA allow natalizumab to return to the market, will it approve future VLA-4 agents, and what are the implications for other therapeutic areas for which VLA-4 antagonists are in development?

In this Decision Resources report, the VLA-4s potential as a drug target is examined, the therapeutic markets most likely to be affected by a halt in VLA-4 development are identified and comment on the likelihood of success for VLA-4 agents in clinical trials is provided. In addition, the potential long-term implications for the U.S. drug approval process in the wake of the problems with natalizumab are discussed.

The development of three cases of progressive multifocal leukoencephalopathy (PML), a rare opportunistic infection, in patients taking the recently approved natalizumab (Biogen Idec/Elan's Tysabri) has prompted a halt on clinical development of some VLA-4 antagonist drugs. VLA-4 is believed to be a promising target for various inflammatory diseases, and these new safety concerns have created obstacles for many emerging therapies in multiple indications.

It is believed that natalizumab's efficacy in the treatment of multiple sclerosis (MS) makes it likely that the agent will reenter the market, although it will likely no longer be a first-line therapy. The future of other VLA-4 antagonists in development for MS will depend on the emerging agents' efficacy and safety profile as well as the companies' ability to wait out the safety investigation.

The future of VLA-4 antagonists for treatment in other therapeutic areas is less certain. Natalizumab was also in development for the treatment of Crohn's disease (CD); however, we feel that increased safety concerns will limit its use for this indication, and other VLA-4 antagonists for CD have been discontinued owing primarily to limited efficacy. More a4 integrin antagonists are under development for the treatment of asthma than for any other therapeutic area, but progress on these compounds has been slow. The safety concerns associated with long-term use and physicians' generally conservative prescribing attitude for this indication make the future of VLA-4 antagonists in this therapeutic market questionable.

The problems associated with natalizumab, coupled with the withdrawal of the COX-2 inhibitors in late 2004, have created increased scrutiny in the regulatory process. In the short term, the FDA will likely begin demanding more-rigorous clinical trials of emerging agents. Other potential changes include increased transparency of clinical trial data and increasing FDA control over labeling and direct-to-consumer advertising.

Tysabri is not an antagonist but an inhibitor so although it is the same class of drug it works in very different way to the recent case of 6 trial patients at northwick park hospital who were in intensive care for a while after receiving a new drug for asthema/cancer/MS.

happy easter elan holders! been as predicted for the shares over the past few weeks, but there have been some interestingn share deals, involving unusually high buys. Now i cant say if someone knows something but from the looks of it someonde does and the positive outcome will reap great rewards.

Add to this the phase one trial results of their altesheimers drug due out in may, and this could be the start of something big. Cheap pharma equity buy now think 12 euro still the right price. Twelve months time will seem like dreamland!

double post sorry

I thought that this is one of the funniest peices of journalism that I have read in a while, yet again the good ole Boston Globe (a name you may recall likened Tysabri to having AIDS! and claimed 90% of doctors would not perscribe it if it returned. (yeah whatever guys! nice try)) having failed to derail the FDA advisary panel in their unanimous vote to return tysabri to the market place by printing unsound peices on the drug itself, now decides to have a pop at the mambers of the panel!

No end to FDA disclosure debate
New waiver law fails to quiet criticism over experts' financial ties to drug companies
By Diedtra Henderson, Globe Staff | April 21, 2006

WASHINGTON -- When a Food and Drug Administration panel of a dozen experts voted to bring back to market the multiple sclerosis drug Tysabri, five had financial ties to the drug's maker, Biogen Idec Inc., or one of its competitors.

The financial ties were disclosed under a law passed last November meant to limit industry influence on the FDA's actions. The law doesn't bar doctors, researchers, statisticians, and other experts from participating if they have received drug company money. Instead, the FDA can grant them waivers but makes the experts disclose those financial ties.

Managing conflicts of interest that accompany top scientists is a juggling act the FDA has been doing for years. The new law was supposed to make it better without grinding FDA approvals to a halt. Since the law was passed, the FDA has issued nearly 100 waivers -- and the controversy hasn't faded.

Critics say the new transparency has changed little and scientists who have conflicts of interest can still guide FDA decision making. The FDA counters that public health would suffer if the agency bypassed the nation's best scientists because of funding sources.

''All behavior is guided by both conscious and unconscious motives," said Dr. Karl Kieburtz, the Tysabri advisory committee chairman who is also a consultant to Biogen. ''Consciously, I'm not aware of any swaying of my decision-making based on the fact I did consulting for Biogen Idec within the last year."

A neurology professor at the University of Rochester, Kieburtz voted to return Tysabri to the market. The FDA doesn't have to follow the advice of its panels but usually does. Biogen, based in Cambridge, marketed Tysabri with an Irish partner, Elan Corp. The companies voluntarily pulled Tysabri off the market after the drug was linked to a potentially fatal brain infection.

The panel unanimously agreed in early March to bring Tysabri back and said in a 7 to 5 vote that patients could use it first, rather than after trying older therapies. The FDA is expected to disclose its final decision as early as this spring.

The FDA reports panelists' financial ties in broad categories, such as less than $10,001 per year, and from $10,001 to $50,000 per year. The disclosure on the FDA's website says Kieburtz received $10,001 to $50,000 in the prior 12 months from the drug's sponsor and less than $30,000 per year as a consultant for three Biogen competitors.

In an interview, Kieburtz offered more specific information, saying he received no more than $12,000 from Biogen, and that his consulting does not have to do with MS or Tysabri.

Kieburtz said he gave the payments to the University of Rochester or to charities. Another FDA adviser on Tysabri, Dr. Steven DeKosky, the chairman of the University of Pittsburgh Medical School's department of neurology, agrees with the FDA that federal advisers with no experience running clinical trials -- which by their nature are often funded by drug companies -- could do the public a disservice.
DeKosky said he didn't know he had a conflict until he filled out the FDA's disclosure forms in which he had to list all work he'd done recently for the industry. The FDA advisers report past and present financial ties to drug companies, and future financial interests they are negotiating. On it, DeKosky disclosed he'd received less than $10,001 as an industry sponsored speaker and was paid less than $10,001 by Pfizer Inc. as a visiting professor. Until the FDA issued his waiver, DeKosky said he did not know a rival MS drug is made by a company that has a financial agreement with Pfizer.

''It certainly didn't enter into any of my thinking. I am supposed to have a reputation as a honest, straight-shooting guy," he said.

The Center for Science in the Public Interest, Washington-based consumer advocates, argues advisers should be independent and the FDA shouldn't grant any waivers.

''Period. End of story. Get rid of scientists with conflicts from serving on the FDA advisory panels," said Merrill Goozner, director of the center's Integrity in Science project.

Dozens of times each year, the FDA empanels advisers plucked from academic institutions, government agencies, and industry. The advisers read stacks of documents before meetings and sit through hours of complex scientific presentations and often emotional testimony from patients. The experts cast votes on such questions as whether to strengthen warning labels for antidepressants and attention deficit remedies taken by millions or whether to lift sales restrictions on silicon gel breast implants. Industry representatives on the panels cast nonbinding votes.

The new law was spurred by high-profile hearings last year on a troubled class of painkillers that included Bextra, Celebrex, and Vioxx. The FDA came under congressional fire for permitting federal advisers who had accepted money from makers of those drugs to vote on whether the painkillers should be sold. In response to the new law, the FDA now posts conflict notices for its advisers on its website in advance of meetings.

Andrew von Eschenbach, the FDA's acting commissioner, said during a recent congressional hearing that the FDA's push to attract the best experts leads to senior scientists who receive drug industry sponsorship. Barring those researchers would result in smaller panels with less expertise.

''I do not believe that it is a process where we simply can exclude or ignore anyone who has remotely been associated with any organization or any program that's relevant to the subject matter," von Eschenbach testified. Barring those scientists would ''undermine the ability to have the best minds make the best decisions."

MS, a disease of young adults, disrupts communication between the brain and other parts of the body, resulting in symptoms that can intensify with little warning. Some have difficulty concentrating, remembering or making decisions. Others are rendered unable to speak, write or walk.

Current drugs and experimental therapies aim to reduce the number of exacerbations in hopes of slowing the progression of physical disability. Because Tysabri worked well in curbing flare-ups, some patients clamored for its return.

Other Tysabri advisers reached by The Boston Globe who received FDA waivers said drug industry funding did not influence their votes.

Dr. Lily Jung, the medical director of the neurology clinic at Swedish Neuroscience Institute in Seattle, received $10,001 to $50,000 in the previous 12 months from Biogen and less than $20,000 from two rivals with competing MS drugs as a speakers' bureau member. Jung, the consumer representative on the panel, said she advocates for MS patients, not the companies selling MS drugs that sponsor her talks. ''I don't think it conflicts at all."

Dr. Ralph L. Sacco, a Columbia University neurologist, did not return several calls seeking comment. According to the FDA, Sacco received less than $10,001 in consulting fees in the previous 12 months from a Biogen competitor.

Dr. Larry B. Goldstein, a Duke University neurologist, received $10,001 to $50,000 in the previous 12 months from one Biogen competitor and less than $10,001 per year from another rival for consulting work unrelated to MS. He said drug company funding did not impact his vote ''one way or the other."

Diedtra Henderson can be reached at dhenderson@globe.com.

Copyright 2006 Globe Newspaper Company.

all i can say is nice try Globe, Tysabri will return and the entire MS community wil rejoyce. its quite sad how many vested interests are having a go at the best MS therepy to emerge ever....the game continues....

more fallout from the FDA panel members debate, shares lower today as the FDA gets flack for having panel members who recieve payments from drug companies and also sit on their advisory commities. Good time to top up I think....on the plus side stage one trial data due out at the begining of May.

Did you get your top up Crippy? Well timed if you did, hopefully we'll get more of a boost when the US opens.

Or prehaps not... that was a short lived rise.

yup doubled my stake :) good news from european drug regulatory agency endorsing use of Tysabri for relapsing remitting MS. Spoke to Biogen idec's head of clinical science on thursday, and he was less than forthcoming about the future of tysabri but i put it to him also that the european position on the drug is was waiting toi see which way the FDA went and he said he couldnt possibly comment, but i suppose that means yes, as shown by yesterdays anouncement, which was promising, but still reserved, i have a feeling that they are waiting for the fda and also to see what limited usage of the drug does for the patients. Also been trying to talk to my consultant, whos secretary was not answering her phone on friday! Frustrating but at least the future looks much brighter now.

That's good to hear!

more news....been abit slack on this one should have posted sooner....

Elan reports smaller 1Q loss of $33.3M
SHAWN POGATCHNIK
Associated Press
DUBLIN, Ireland - Elan Corp. PLC, the Irish biopharmaceutical company whose hopes are tied to a suspended multiple-sclerosis drug, reported a smaller first-quarter loss Thursday and forecast a return to profitability if U.S. sales of Tysabri resume.

Elan said it lost $33.3 million inl;uding stock compensation expenses in the January-March quarter versus a loss of $115.6 million in the same quarter a year ago. It said sales rose 31 percent to $134.3 million from $102.7 million a year earlier.

On the Irish Stock Exchange, Elan's shares initially rose but fell back in a broadly negative market, closing down 8 euro cents (10 cents) at 11.32 euros ($14.26). The company's U.S. shares fell 20 cents, or 1.4 percent, to finish at $14.48 on the New York Stock Exchange.

Analysts say the future of the Dublin-based company depends on the return of Tysabri, a drug withdrawn from sale in the United States early last year after being linked to a rare, often fatal brain disease. The U.S. Food and Drug Administration is expected to announce by June 28 whether Tysabri sales can resume.

Both company officials and market analysts said they expect Tysabri to get the green light.

"We remain committed to making Tysabri available for patients in the U.S. and Europe and are confident that, with the financial leverage we've created over the year, revenues from Tysabri will accelerate our return to profitability," said Elan's chief financial officer, Shane Cooke.

"Once Tysabri is back on the market, momentum will return to the stock," said Ian Hunter, an analyst for Goodbody Stockbrokers in Dublin.

In November 2004 the FDA approved Tysabri for sale to the approximately 350,000 people in the United States who suffer from MS, an incurable disease of the central nervous system. Elan and Biogen Idec Inc., its U.S. partner in developing Tysabri, withdrew the drug three months later when three people taking Tysabri in clinical trials contracted the brain disease PML; two died. Both companies subsequently said they found no additional PML cases among other Tysabri users.

The suspension of Tysabri hammered Elan's shares, which fell from above 20 euros to as little as 3 pounds before mounting a gradual recovery over the past year.

On March 9, an advisory panel to the FDA voted unanimously to recommend that the agency should permit Tysabri to be sold again in the U.S., subject to new restrictions. The panel cited the drug's strong ability to help MS sufferers block the recurrence of key effects, such as sudden partial paralysis.

Sorry about the delay but looks as if they are beginning to get their ship in order, at last, perhaps the Tysabri mess could mean a leaner more focused and productive Elan? whats the phrase?....something about a sliver lining? :)

lack of news flow taking its toll on price this weeek. also a jittery NY combines to give an interesting closing price today time for another top up me thinks in morning....but will be watching new york closely @ time of writing ny elan price $14.55 and rising

positive sentiment driving shares upwards. Good to see some market beiief after all this time. Could it be an announcement from the FDA is immenant? think this could be a turning point, on a day that has not exatly been positive on the general market, elan bucks the trend!