Posted on 02/28/2005 4:15:27 PM PST by neverdem
By THE ASSOCIATED PRESS
BOSTON (AP) -- The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.
Stocks of both Biogen Idec Inc. and Elan Corp. tumbled, while shares of ther makers of rival MS drugs rose.
The biotechnology companies said in a news release that they have suspended supplying and marketing the drug Tysabri and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.
The companies said the decision to withdraw the drug came after recent reports of two cases of serious effects among patients who used it along with an earlier Biogen Idec MS drug, called Avonex, in clinical trials. In one case, the person died, while in another, the person developed a suspected case of progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system.
Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.
``Our ongoing commitment to MS patients has led us to take these steps,'' said Dr. Burt Adelman, executive vice president of Development at Cambridge-based Biogen Idec. ``Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations.''
The Food and Drug Administration approved Tysabri, which was called Antegren during clinical trials, in an accelerated process after a late-stage study showed that it reduced MS relapses by 66 percent compared with a placebo.
About 5,000 patients have received intravenous infusions of Tysabri since the drug's approval in November, Biogen executives said during a conference call with industry analysts and reporters.
Elan chief executive Kelly Martin told reporters in Ireland, where the company is based, that the drug has been withdrawn as a precaution and that the companies hoped to resume marketing of Tysabri later this year.
The companies said they withdrew the medication after consulting with the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration issued a public health advisory after consulting with Biogen and Elan in the decision to withdraw the medication from the market.
Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said in a statement that the regulatory agency ``continues to believe Tysabri offers great hope to MS patients.''
``We are working with leading experts and regulatory agencies to responsibly investigate these events and to develop the appropriate path forward,'' said Dr. Lars Ekman, executive vice president and president of research and development at Elan. ``Our primary concern is for the safety of patients.''
Biogen shares fell $29.46, or nearly 44 percent, to $37.82 in afternoon trading on the Nasdaq Stock Market, while Elan shares sank $18.37, or more than 68 percent, to $8.53 on the New York Stock Exchange. Those are the lowest prices for both stocks since 2003.
But the U.S. shares of rival MS drugmakers Schering AG rose $1.75, or 2.5 percent, to $72.85 and Serono SA jumped $2.76, or nearly 18 percent, to $18.30 in afternoon trading on the NYSE.
Tysabri was expected to be a big seller for the companies, and sales of Elan shares surged in October amid published reports in Ireland that Biogen could mount a friendly takeover bid for the Irish company. Elan, once Ireland's highest-flying company and a darling of international investors, subsequently issued a statement saying it was not in talks with Biogen about a merger or business combination.
Tysabri -- which also is known by the generic name natalizumab -- has been designed principally to slow the progression of disabilities related to multiple sclerosis, but Elan and Biogen had previously said they believed it could also help sufferers of the gastrointestinal ailment Crohn's disease and rheumatoid arthritis.
In December, the companies announced they were starting a head-to-head study comparing Tysabri with another MS drug called Rebif. That study was to enroll 1,000 patients.
On Feb. 17, the companies announced favorable Tysabri trial results indicating success in slowing MS in patients who had relapsed, with a 42 percent reduction in the risk of the disability progressing compared with patients who took a placebo.
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Associated Press reporter Shawn Pogatchnik contributed to this report from Dublin, Ireland.
FReepmail me if you want on or off my health and science ping list.
Do you have any idea if or how this relates to the use of interferon to fight MS?
I'm sorry, when I first read the headline I thought to myself, well duh, I can't imagine them making any money selling drugs to dead people.
Sad ping.
Tysabri was another way to interfere with the body's immune system attack upon itself.
ANTEGREN One-Year Data from Phase III AFFIRM Study Showed Compelling Results in Multiple Sclerosis
I had to make this diagnosis years ago on a good friend of mine. One of the worst days of my life.
There was a fabulous pain killers in the 80's, I can't remember the name but it began with a Z, that was as powerful as a Darvon but didn't mess at all with your head. It killed a few people so they took it off the market.
I can understand that but when a certain drug is the only thing available to enhance your quality of life, I think maybe they should leave the decision to stop taking the drug up to the patient. Unfortunately trial lawyers will never let that happen.
Exactly, yes. That's what I thought when I heard about Vioxx and the other related pain medications--some people have to live with pain that I can't come close to imagining, and why can't they decide whether or not their relief is worth that risk?
A friend of mine told me recently about this new MS therapy she was trying (this Tysabri, from the article), and she seemed so excited about the science and the possibilities, and I felt so hopeful for her. This article is very disheartening, but isn't this sort of biotechnology relatively new? I mean it feels like a science fiction novel in a way--how can the scientists and doctors think far enough ahead to forsee every possible weird consequence of this level of physical "interference"?
From what I've been reading on MS message boards, many believe the deaths were caused by the combination of Tysabri and Avonex (Biogen's interferon).
Despite this setback, I remain optimistic that good will come from this drug. This is the first major breakthrough in MS since interferons and, even if Tysabri is not the answer, perhaps safer drugs will be developed from it.
If you are interested, there is good discussion here (Mass General MS forum):
http://brain.hastypastry.net/forums/showthread.php?t=69932
I agree. If we treated each other like adults, we would allow legally binding waivers of the right to sue.
Damn. This thread http://www.freerepublic.com/focus/f-news/1350797/posts had me hoping there was some help for 2 of my friends with MS. I hear of more and more cases???
Damn indeed. I have MS (but have been very lucky thus far) and have been watching this drug with great optimism. The only good thing about living in the People's Republic of Massachusetts is that it't a great place to get sick as we have some of the best hospitals in the world.
I wish your friends the best of health; you may want to direct them to the forum I linked in my previous post. It really is a great resource.
Thanks, Steve. I will follow up.
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