New Tysabri worries hit Elan
Elan (ELN) dropped 7% after the Irish drug company and Boston-based partner Biogen (BIIB) said their Tysabri drug for multiple sclerosis can harm patients’ livers. The news was first reported by Bloomberg, which cited a note to doctors posted on the Food and Drug Administration’s Web site. The development comes three years after the companies pulled the drug off the market for 16 months so regulators could probe Tysabri’s link to a rare, fatal brain infection. The drug returned to the market in 2006 after the FDA decided the benefits of the drug to MS patients outweighs the risks. The possibility that Tysabri could damage the liver has been reflected in the drug’s label since last month, Bloomberg reported, but the FDA says some doctors may not have known.
The letter adds some to uncertainty overhanging Elan, which is more dependent on Tysabri revenue than its bigger partner Biogen. Rating agency Moody’s recently upgraded Elan, citing Tysabri’s increasing acceptance in the marketplace since its 2006 relaunch. If reports of liver problems slow those gains, though, Elan’s stock - which has doubled over the past year - could be in for a rough patch.
Check your facts before you jump in with the news, looks like Bloomberg Reuters etc are just another Hedge Fund tool. Elan has 62% institutional holdings, Some more want a piece of the action, Check this page in July and see for yourself. Price will be through the roof. What is it with this tysabri drug, the various agendas at play here are so vast, competitors in early stage trials trying to beat Tysabri with a big stick so their efforts might see the light of day,Hedge Funds trying to jump on board at a nice price. I have never read a bad report from a MS sufferer in relation to this drug since it was launched. Elans problems, are:
1. It owns 50% of a huge drug and they are punching above their weight.
2. The strong contracts they have to protect that 50%, (Just ask Icahn)
3. They have a terrible PR dept, and haven’t engaged in any of these dirty tricks against any of their competitors. ( Although the silence seems to me to indicate that they have a drug that they know will blow the others out of the water).
Its not only MS Sufferers that want this drug, Somebody wants to buy the whole thing.
Roll on tysabri, The more delays we see the more suffering these patients will have to endure. Surely that is the whole reason the drug was designed. Not just to make Institutional Investors rich.
This is not news. This information has been known since before Tysabri was re-approved. Tysabri’s competitors carry the same low risk of liver damage. Many other routinely - and effectively - prescribed drugs may cause liver damage. Tysabri is a miracle drug that is changing lives for the better. MS and Crohn’s patients know the truth.
Old news used to shake shares from weak hands. Elan volume was 6 times the norm for the day, Biogen significantly less. Wonder why someone wants Elan shares so badly?
why would you print old news,this was known and even FDA spokes women said just label expansion.There has been no known cases of severe liver damage,now 25,000 patients on TY
Interesting that an old warning would show up when eln was moving higher.In fact just as it skirted 25 today,very interesting indeed
The following excerpt from a Reuter’s story says it best.
FDA spokeswoman Sandy Walsh, however, said the letter does not reflect new cases but is simply a reiteration of a revised label the FDA approved Jan. 16 as part of the expanded use of the drug for the bowel disorder Crohn’s disease. (Reporting by Kim Dixon, editing by Gerald E. McCormick)
This is OLD news. It was already known and discussed in the labeling. I call lazy reporting!
It should be noted that this is not “News”. The letter to the doctors was required by the FDA in relation to the new Tysabri label following the drug’s approval to now treat Crohn’s disease.
Several reports correctly cited an FDA source that indicated that this is not a NEW concern, merely an administrative task related to the new label.
It is a sad day when reporters at Bloomberg cannot correctly research a “story” and correctly identify it as a non-story. Even more sad is the fact that several other news organizations continue to regurgitate this non-story.
The Food and Drug Administration posted the companies’ letter to physicians online and said patients with any signs of liver damage should stop taking the drug immediately. Regulators updated the product’s labeling to highlight liver risks last month, when it was approved for the new use in the intestinal disorder Crohn’s Disease. The new language instructs doctors to tell patients about the liver problems.
A spokeswoman for Cambridge, Mass.-based Biogen said the company sent its letter to 2,500 physicians who prescribe the drug for multiple sclerosis, and may not have seen the updated labeling. She said liver problems have been reported by less than one in 1,000 Tysabri patients.
The drug posted sales of $343 million for Biogen last year.
Banc of America Securities analyst William Ho said the announcement was “old news,” pointing out that liver problems with Tysabri were revealed at a meeting before FDA’s expert advisers last year. They ultimately voted in favor of approving the drug for Crohn’s Disease. Ho maintained a “Buy” rating for Biogen’s stock with a one-year price target of $73.
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Shameful, amateurish reporting on the ELN/BIIB Tysabri “liver damage” article. Do you people not corroborate the information before printing it?? This was disclosed in JULY, 2007..that would be NINE MONTHS AGO!! FDA has already, today, issued a clarification. Well, I guess I will hinceforth look for my financial news in the National Inquirer; at least they are sensational with a purpose. Fortune Magazine, how far you have fallen and how close to irrelevant you have become. Quite pathetic, actually.