This Is MS Multiple Sclerosis Community: Knowledge & Support

Again!

www.marketwatch.com/news/story/biogen-e ... story.aspx

For some reason it won't go straight to the story. In the search bar in the upper right corner type in "tysabri" . Then scroll down to the first story.

Glad they are having a conference call for analysts and investors tomorrow- what about the patients???


LOS ANGELES/NEW YORK, July 31 (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research, Stock Buzz) and Elan Corp Plc (ELN.I: Quote, Profile, Research, Stock Buzz) have notified regulators of two new cases of a potentially deadly brain disease in multiple sclerosis (MS) patients being treated with Tysabri.

Biogen shares dropped about 23 percent in after-hours trading, while Elan's shares fell 45 percent in New York.

"This is going to have very broad, very wide ramifications for the commercial prospects of the drug because there's just a lot of uncertainty here," said Cowen & Co analyst Eric Schmidt.

Tysabri, co-marketed by Ireland's Elan and Cambridge, Massachusetts-based Biogen, was withdrawn from the market in 2005 after three patients developed the brain infection known as progressive multifocal leukoencephalopathy (PML).

The drug returned to the market in 2006 with warnings after the U.S. Food and Drug Administration decided MS patients willing to accept the risks should be able to have access to the drug's potential benefits.

The two new PML patients, one of whom is hospitalized, are in the European Union, the companies said.

More cases are likely and physicians are likely to reduce the number of patients they start on the drug as they are reminded of long-term potential safety issues, Morgan Stanley analyst Steven Harr said in a research note.
Elan and Biogen said more than 31,800 patients were being treated with Tysabri as of the end of June and second-quarter sales totaled $200 million.

"We've said all along, and the FDA has also stated and it's clearly outlined in our label that we expect to see additional cases of PML," Biogen spokeswoman Naomi Aoki said. "These are the first cases we've seen since the reintroduction in the U.S. and approval in Europe two years ago."

She said the company believes that heightened clinical vigilance has been the best way to monitor for PML and that heightened vigilance was critical in identifying these cases.

Schmidt said, the "key fear factor in the market place is going to be what happens when you treat beyond two, two and a half years ... Nobody knows the answer and that's kind of scary."

"I think you'll see a general pause in the market place, especially in the U.S., where safety has become more of a lightning rod issue, in part driven by the litigious nature of our society," the analyst said.

Tysabri also won U.S. approval this year to treat adults with moderate to severe Crohn's disease who have had a poor response to, or cannot take, other therapies.

Shares of Biogen, which closed at $69.76 on Nasdaq, fell to $53.68 after hours, while shares of Elan, which closed at $20.05 on the New York Stock Exchange, were trading at $11.00.

Elan's shares had already lost one-third of their value on Wednesday when investors sold the stock after disappointing data on an experimental Alzheimer's drug Elan is developing with Wyeth (WYE.N: Quote, Profile, Research, Stock Buzz).

Biogen and Elan have a scheduled a conference call with analysts and investors for Friday morning. (Reporting by Deena Beasley and Bill Berkrot; editing by Jeffrey Benkoe and Carol Bishopric;((deena.beasley@thomsonreuters.com; 1-213-955-6746; Reuters Messaging: deena.beasley.reuters.com@reuters.net))

Dear members my name is SEEVA from SYDNEY last week I have met my neuro in a m.s clinic in sydney but he is first time using TYSABRI so he is very concern about PML. AND REFUSE TO GIVE me and my other m.s friends the new medication TYSABRI.HE has asked me to go for more blood test and another MRI AND EYE TEST.Then dependent of my test result HE WILL CONSIDER giving me TYSABRI.Inthe mean time the later news the report from BIOGEN INDEC has confirmed futher two cases of PML IN JULY 2008
will our DRS in AUSTRALIA do not use TYSABRI for m.s people. we are all M.S people are waiting for TYSABRI for the past five years. so we all very disopointed. Any members know about the latest news.please reply.
regards
seeva

Hi, Seeva,
I think they disclosed the two new cases od PML because of very particular monitoring of each patient in EU (see page 4):
http://www.emea.europa.eu/humandocs/PDF ... -PI-en.pdf
The doc in Europe are very cautious about natalizumab (see TOUCH and TYGRIS Prescribing Programme - <shortened url>.
They do not precribe it without very detailed laboratory and MRI tests, comparing benefit and risks to each patient - Tysabri medicaton is available for six month only and can be prolonged if all the tests (includes of JC virus) are OK.

The latest open news:
<shortened url>

My neuro was involved with the Tysabri trials. I just saw him the day before the new PML cases were announced, and he offered me Tysabri treatment. He told me it is paid for under PBS (i.e. our local government funding for medications, I have no idea what DRS? is). He is very respected here in Sydney (and also overseas I have found) as an MS specialist. His name is Prof Pollard, and he can be found at http://www.bmri.org.au/index.html The address on the site is wrong, as they have recently moved to an office in the building next door. I dont know if the number is correct, as I use the number 02 93510730.

He is involved heavily with research and trials, including FTY-720, Tysabri and now I am talking to him about being involved in the next Campath trial.

Call them for an appointment (it can be a long wait) and ask them regarding Tysabri.

Good Luck.

Hi cure thanks for your infomation about professor John Pollarad. We all know about him long time. His clinic in Camperdown multiple sclerosis clinic tel.no. 02 93510730. My m.s friend and I am going to see him in his clinic in Septemper my few friends already in the tysabri trail and had few infusions from Profess Pollard. Also the Dr. Michale Barnett who is also good m.s Dr. Working with Professor Pollard. I went to Westmead multiple sclerosis clinic was run by Professor Rob Heard. He too respected m.s specialist. But he is not working with the clinic. The new repaced Dr. is Dr. Steve Vucic two weeks back I have met him first time. My friends and I are taking only LDN for the past 12 months. No more futher attack or relapses during the time. But the new Dr. was very upset about the use of LDN. And asked us to stop and go back to interferons like Avonex or Rebif injection. But we all refused to discontune the LDN. He was saying LDN can cuase more damage for m.s than treating m.s also he is anti Tysabri and talking all the time PML but I’m detemined to try Tysabri. So finally he send me to do few test like blood and new MRI. Next week my friends and I were going for MRI scan. After then we will see the Dr again in September. But we take all the results and go and see the Professor Pollard's clinic. Your infomation I just got the print copy to give my m.s friends in Lidcombe m.s center tomorrow. Many thanks for your infomation my friends are very gratefull you and other ThisIsMS members. We all meet every week for our rehab exercise at study ms centre Lidcombe. Our bad luck there is no medical advisors for mssociiety nsw. So we can get any up to date medical news about any new drugs. Normally I have give more infomation to them. Many thanks. We keep inform to this forum. Regarding drs was doctors in short drs.
Regards

Seeva

Hello everyone,

This is my first time posting. My daughter has had MS for a little over 5 years. She was on Betaseron for almost all that time. In November 2007 her doctor suggested she try Tysabri. She had her first Tysabri treatment on December 22nd. For the first 3 months she didn't see much in the way of improvement. She gets really bad headaches since she's been on Tysabri but after her 3rd infusion she started to feel better with fewer symptoms.
She was due for her 9Th treatment last week and when we got to the doctor's office her doctor told her that he was no longer suggesting the use of Tysabri unless his patient was wheelchair bound, or was severely impaired by MS. He told my daughter that he would rather have her go on Copaxone with a once a month steroid infusion to eliminate the possibility of her developing PML.
He said they were told that now that they have so many people on Tysabri (over 3,000) there will unfortunately be a lot more cases of PML developing in patients taking Tysabri.
So with this new information, my daughter stopped taking Tysabri as of this month.
She will be starting her new Copaxone/steroid treatments in 2 weeks.
She was very upset by his decision but is very afraid of developing PML.
I guess there are no guarantees with any of the MS medications so she is taking her doctor's advice and stopping Tysabri. She is afraid that she will become symptomatic again and is afraid of what will happen now that she is off Tysabri.
Good luck to all of you. I know you must be worried as we were by the 2 new cases of PML. But this a personal choice that you all have to make, unless they decide to take Tysabri off the market if too many cases of PML develop in the future.
I hope that doesn't happen because I know it has helped so many people feel so much better.
BTW! My daughter was diagnosed at 27 years old and is now 32.

It makes you wonder after a statement like that whether there is information that the docs are hearing that hasn't been released to the general public as yet!

Harry

Hello Gram2hgbj
I have been taking Tysabri and like your daughter, i have experienced improvements since my 3rd infusion.
From what you say, i think your daughter's neurologist is afraid of being trialled in case of PML
But if your daughter does not agree with him, why not going and ask another neurologist?
Furthermore, he is telling you a few lies:
there are not over 3 000 people currently taking Tysa but over 43 300. This makes 2 PML/43 000 = 0,046 % chance to get a PML while taking Tysabri [[u] What about the chance for your daughter to soon no more walk?
About his other argument ("he was no longer suggesting the use of Tysabri unless his patient was wheelchair bound"), in most cases , when you are wheelchaired, it means you have a progressive MS(from what I have seen for my 12 years' long MS) but Tysabri is only for active remitting relapse MS. So I guess he never prescribes Tysa.

I can't deny there is a risk when taking this drug. But taking account of all what it has offered me: 16 months without relapse, a better ability to walk i would not stop it just to make my Dr feel safe.

sorry, 2/43 000= 0,0046% is the chance to get a pml
whereas there are about 39,000 fatal crashes in the US each year
39 000/300 millions americans=0,013% chance to get killed while driving.
so before stopping tysabri, sell you car!!!

Unfortunately, quoting those numbers for Tysabri and PML is not how statistical probability is determined. There are several factors that are used to figure out what the chances are for one possibly coming down with that disease.

Having said that, one should base their decision on using Tysabri after speaking with their neurologist and learning as much as possible so they can make an INFORMED decision.

Harry