Tysabri info

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

The Irish Times

Postby better2gether » Fri Oct 28, 2005 2:59 pm

From The Irish Times
(Only the Tysabry related part)

October 28, 2005
by Dominic Coyle

Biotech group Elan still has high hopes for its breakthrough multiple sclerosis (MS) drug Tysabri but it's not waiting around for it to deliver.

The Irish group has been through a torrid time in the months since it withdrew the drug from the market after two patients fell ill with a generally fatal brain disease.

Tysabri had only been on the shelves a few months after winning fast-track approval from the US regulator, the Food and Drugs Administration (FDA), on the basis of just one-year's data.

Elan is still bullish about the prospects for the drug. Speaking to The Irish Times this week, chief executive Kelly Martin said the experience of the drug in the short time it was available was that it had attracted heavier demand than even the most optimistic analysts had projected.

Elan says it has exceptionally good dialogue with the FDA before and since the removal of Tysabri. "It's fair to say the agency is being as responsive and flexible and thorough as they can be with us to work through the Tysabri opportunity for patients, that's what we do," says Martin.

" Since the drug was pulled off the market, we now have the two- year data and it tells us the drug is better than earlier data on which the initial approval was based - in terms of safety, efficacy and EDSS quality of life scores. "

" Over 50 per cent of the patients on the drug for more than six months show complete stoppage of signs of progression of MS. "


The company accepts that it is going to be a monotherapy drug but, as Elan research chief Lars Eckman noted yesterday, investigation since the suspension of Tysabri indicates that it is only a minority of MS patients that will be at risk to the neurological disease that led to the drug's suspension.

" At the end of the day, it is going to be a patient demand product. I believe patient demand is as high or higher than it was a year ago. "

" I also think Tysabri now, perversely, is now the best understood drug in the history of the pharmaceutical business. "

" So I see no reason from a medical point of view why Tysabri won't be the dominant MS therapy until there is one that is better than it. "
.
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm

Advertisement

Postby DenverCO » Fri Oct 28, 2005 4:24 pm

Woo-Hoo! Bring it on! :D
User avatar
DenverCO
Family Elder
 
Posts: 117
Joined: Wed Nov 24, 2004 4:00 pm

Re: The Irish Times

Postby HarryZ » Fri Oct 28, 2005 6:33 pm

It's amazing how crafted these press releases are when it comes time to try and impress the financial world to go out and buy as much Biogen/Elan stock as possible in order to prop up the price!!


" Since the drug was pulled off the market, we now have the two- year data and it tells us the drug is better than earlier data on which the initial approval was based - in terms of safety, efficacy and EDSS quality of life scores. "


That's strange...when the two year trial data was released, the info stated that the data confirmed what the one year data showed. I don't recall anything about it being "better". I guess the "safety" data wasn't all that accurate, was it!!!???

" Over 50 per cent of the patients on the drug for more than six months show complete stoppage of signs of progression of MS. "


I presuming that they are talking about the monotherapy patients who weren't all that sick to begin with as far as levels go with MS. One very knowledgeable participant over on the Brain Talk Forum really got into the trial data and he came up with the statistical conclusion that Tysabri was only about 12% more effective than the CRABs when it came to overall efficacy.

The company accepts that it is going to be a monotherapy drug but, as Elan research chief Lars Eckman noted yesterday, investigation since the suspension of Tysabri indicates that it is only a minority of MS patients that will be at risk to the neurological disease that led to the drug's suspension.


I guess that's great....unless of course you are one of the patients in the "minority" that ends up with PML!!!

" At the end of the day, it is going to be a patient demand product. I believe patient demand is as high or higher than it was a year ago. "


This is beginning to sound just like the press releases that Biogen/Elan made prior to Tysabri getting approved last fall. Yep, let's get that stock price propped back up!

" I also think Tysabri now, perversely, is now the best understood drug in the history of the pharmaceutical business. "


I find this comment mind boggling!! Almost every single statement that I have read about from experts in the field, especially the PML people, all continue to say nobody is sure yet just how Tysabri and PML are linked. If that is the "best understood drug in history", God help us!!

" So I see no reason from a medical point of view why Tysabri won't be the dominant MS therapy until there is one that is better than it. "
.


Spoken like a true marketing person. Boy is this starting to look like "deja vu" all over again!!

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2320
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Call for Action -- Today!

Postby better2gether » Wed Nov 02, 2005 2:23 pm

From another messageboard.

Call for Action -- Today!
by: lovesjohndory 11/02/05

The FDA's Office of Special Health Issues has been preparing an analysis of all communications received by FDA on the subject of Tysabri. This analysis is perceived to be of "stakeholder input regarding a pending FDA regulatory action." The more comments received in support of Tysabri, the more pressure there may be on FDA to act expeditiously, and devote adequate resources to this review.

I was informed this morning that the analysis will be closed out soon, completed and forwarded to the reviewing division at FDA.

I ask that everyone interested in Tysabri being available as a treatment option for MS patients immediately send an email to the address below, and encourage everyone you know who is interested in MS and effective treatment options to do the same, today.

Here is the address (put "Tysabri for MS" in the subject header, and explain in your own works why this drug should be available for MS patients and their neurologists who want it):

OSHI@oc.fda.gov
.
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm

ACCEPTANCE OF SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION

Postby better2gether » Thu Nov 17, 2005 3:09 pm

BIOGEN IDEC AND ELAN ANNOUNCE FDA ACCEPTANCE OF SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION AND PRIORITY REVIEW DESIGNATION FOR TYSABRI® IN MULTIPLE SCLEROSIS


Cambridge, MA and Dublin, Ireland - November 17, 2005 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) for the treatment of multiple sclerosis (MS) has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA).

The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On September 26, 2005, the companies announced they had submitted the sBLA for the market re-entry of TYSABRI for MS and requested Priority Review.

The sBLA for TYSABRI in MS includes:

final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS;
integrated safety assessment of patients treated with TYSABRI in clinical trials; and
revised label and risk management plan.
"We are pleased that TYSABRI has received Priority Review designation, which we believe, reflects the unmet need in MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the FDA throughout the review process and are hopeful that we will be able to bring TYSABRI back to people living with MS."

"We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide TYSABRI as a treatment option for MS patients in need," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We will continue to work closely with the FDA as they review the filing so that TYSABRI can be made available with an appropriate benefit-risk profile."

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan recently completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and neurology. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.

http://www.biogenidec.com/news/BiogenIDECPR_104.htm
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm

Postby DenverCO » Thu Nov 17, 2005 5:26 pm

LET'S GET THIS PARTY GOIN'! :D
User avatar
DenverCO
Family Elder
 
Posts: 117
Joined: Wed Nov 24, 2004 4:00 pm

Postby bromley » Fri Nov 18, 2005 6:17 am

Denver,

Glad the news has made you and many others happy - in the UK we are unlikely to see this treatment for some time but look forward to hearing (if it is re-introduced) how people do on it.

I thought you were having Novantrone? Has this had the expected effect? Would you be allowed to start Tysabri having been on a powerful immuno-suppressant?

Bromley
User avatar
bromley
Family Elder
 
Posts: 1889
Joined: Fri Sep 10, 2004 3:00 pm

Postby poetriri » Fri Nov 18, 2005 7:29 am

i was lucky enough to get 2 doses of tysabri last spring....and it got me off my walker and back to my cane...as well as off all of my anti spasticity meds! I cant wait to try it again...and see what else improves!

Heather
User avatar
poetriri
Getting to Know You...
 
Posts: 12
Joined: Fri Nov 11, 2005 4:00 pm
Location: South Bend, IN

Postby DenverCO » Fri Nov 18, 2005 10:29 am

bromley wrote:Denver,
I thought you were having Novantrone? Has this had the expected effect? Would you be allowed to start Tysabri having been on a powerful immuno-suppressant?
Bromley


Bromley,

I have had 2 Novantrone infusions and am scheduled for the 3rd at the end of December. Before I started Novantrone I asked my neurologist how long I would have to wait between Novantrone and Tysabri and he said a few months. I just read on another board that "they" have advised waiting 3 months. If I have Novantrone #3 in December, that will be perfect timing.

By the way, Novantrone has been a piece of cake and I have noticed slight improvement. I am hoping for even better results after #3.
User avatar
DenverCO
Family Elder
 
Posts: 117
Joined: Wed Nov 24, 2004 4:00 pm

Elan keeps chief on board with improved contract

Postby better2gether » Wed Dec 07, 2005 3:11 am

The Times December 07, 2005

Elan keeps chief on board with improved contract

By Richard Irving



The board of Elan, the Irish drugs maker, is to approve a new open-ended contract today for Kelly Martin, the chief executive.
The new agreement will tie the former investment banker to the company ahead of the expected relaunch of Tysabri, its multiple sclerosis treatment, next April. It will replace a three-year fixed contract that expires at the end of the month.

According to the latest report and accounts, Mr Martin earned just over $834,000 (£478,000) in salary last year. He also received 200,000 stock options with a weighted strike price of $7.47 in lieu of an annual cash bonus, which he waived.

Under the new deal, Mr Martin’s basic pay and benefits package is understood to be broadly in line with current levels. However, the new contract will include more performance-related share options, reflecting the board’s determination to ensure that Mr Martin oversees the relaunch of the firm’s most promising drug.

The company pulled Tysabri from pharmacy shelves in late February amid fears that the drug might be linked to progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain disease.

Elan has since reviewed the case studies of three patients who appeared to contract PML while taking Tysabri, as well as additional data on more than 3,500 patients who had participated in trials of the treatment.

The information, which has since been lodged with the US drug regulator, appears to strengthen claims by the company that Tysabri is the most effective treatment available for multiple sclerosis.

Scientists have collated clinical trials over two years showing that 67 per cent of patients taking Tysabri experienced a reduction in debilitating relapses. The results are slightly better than Elan’s initial tests, which covered one year and considerably better than some analysts had hoped for.

The US watchdog has vowed to give Tysabri a priority review and a decision on its future is due next March.

It is expected that, because the latest data is better than that supporting Tysabri’s initial filing for approval, regulators will be minded to approve the medicine.

Current talks between regulators and Elan are understood to be focusing on what the company must do to ensure that doctors prescribing the treatment recognise immediately any symptoms that might suggest the early onset of PML.

Kelly Martin said yesterday that it was inconceivable that the drug would not be reapproved. He expected more than 25,000 patients who had pre-registered their intention to switch to Tysabri at the time of its launch in November 2004 to make the switch immediately the drug becomes available, despite the bad publicity.

The company expects to break even on Tysabri, which will sell for $23,000 per person per year, once it has signed up 20,000 patients.

Mr Martin added that a decision from European regulators was expected next June or July.



http://business.timesonline.co.uk/artic ... 78,00.html
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm

Tysabri Tries Again

Postby better2gether » Wed Dec 07, 2005 3:24 am

Motley Fool

Tysabri Tries Again

Tuesday December 6, 3:55 pm ET
By Stephen D. Simpson, CFA


Investors in Irish biotech Elan (NYSE: ELN - News) are probably hoping that the second time's the charm. After some extensive work, the company and its partner Biogen Idec (Nasdaq: BIIB - News) have resubmitted their troubled multiple sclerosis drug Tysabri for FDA approval.

The two companies received a priority review designation from the FDA. As a result, their application will be reviewed more quickly, potentially shaving as much as four months off the normal time. The reason why the companies got this priority review for Tysabri shouldn't be ignored: The drug satisfies a significant unmet clinical need.

Readers without direct experience with multiple sclerosis may not appreciate just how debilitating it is, or the impact it has upon people's lives. There are few good options available for treatment, and patients don't always respond to them especially well. And for whatever safety problems there might be with Tysabri, the drug was quite effective for some patients.

We at The Motley Fool have talked a lot about Tysabri and the safety issues, and there's no need to rehash that. (The drug has been linked to a few cases of the rare neurological disease PML, or progressive multifocal leukoencephalopathy.) The question now is how the FDA will respond. Will the companies' newly submitted data, safety assessment, and revised labeling be good enough for approval?

It's a tough call. On one hand, I'm sure the FDA wants to be sensitive to the needs of some very sick individuals, many of whom would likely be willing to assume whatever slight (but serious) risks go with Tysabri in exchange for the possibility of a better quality of life. On the other hand, the FDA has been a tough customer of late with some other drugs -- potentially holding up Bristol-Myers' (NYSE: BMY - News) experimental diabetes drug Pargluva for years by requesting more data.

FDA approval is now the name of the game. Even if the FDA slaps a serious black-box warning label on the drug, once it's approved, doctors have considerable latitude in how they prescribe it for patients. And considering that Tysabri can cost more than $20,000 per patient per year (and there are about 350,000 MS patients in the US), even capturing 10% of the market would be a very meaningful opportunity for Elan.

I said before that I thought the safety concerns would take away Tysabri's chance to be a blockbuster (generally defined as $1 billion in sales). Maybe I'll be right, maybe I'll be wrong. I'd be more than happy to write a follow-up piece a year from now saying I was wrong to doubt Tysabri's potential -- not because it means that Elan shareholders made money, but because it would mean that a lot of patients are seeing some real improvement in their lives. In any case, Elan shareholders should buckle their seatbelts. The next few months are apt to be a heckuva ride.

http://biz.yahoo.com/fool/051206/113390254617.html?.v=1
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm

Re: Elan keeps chief on board with improved contract

Postby HarryZ » Wed Dec 07, 2005 6:45 am

Current talks between regulators and Elan are understood to be focusing on what the company must do to ensure that doctors prescribing the treatment recognise immediately any symptoms that might suggest the early onset of PML.


This possible condition of re-approval could prove interesting. We know from various comments by MS patients on the CRAB drugs that some docs have not bothered to monitor for NAB's or diminished liver function. Not until the patient becomes quite ill is some action taken.

I wonder what kind of protocol will be required for docs to monitor for indications of PML and what expense the patient may have to endure.

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2320
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

If You Knew Lindsey......

Postby better2gether » Sat Dec 31, 2005 1:29 pm

From another message board.

If You Knew Lindsey......

This post has 220 recommendations
12/30/05

Like I know Lindsey, you'd love her, too.

I first met Lindsey in 2002. She was BPRX too, back then. She changed her moniker to Elan_Lindsey. I was battling the shorts nightly, but not by myself. Nope. There was Lindsey with the links and the background notes. We became good friends.

It wasn't until shortly after Black Monday we discovered Lindsey had MS and was in the Affirm trial. All that time she kept it to herself. Luckily she was on Tysabri. The miracle drug. She had gone from 5 to 1 on the EDSS scale.

Now for the tough part. Because Tysabri was withdrawn, Lindsey is back to 5. I won't go into the details, but she desparately needs her Tysabri. When posters are insensitive to the plight of MSer's, it's more than i can stand.

Lindsey is a mom, daughter, wife, mother-in-law, mensa, champion knife thrower, world-class artist, champion chess player, pool shark, card sharp,..should i go on?

I could care less about the pps of Elan. I know it is going up, as i have posted. What i care about is my friend getting her Tysabri. Lindsey is a class act. She deserves and needs Tysabri.

Happy New Year, Lindsey! May this year bring you what you deserve!

Elmer
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm

Hang in there Lindsey!

Postby poetriri » Mon Jan 02, 2006 12:10 pm

Lindsey's movement on the edss is inspirational...tysabri will be back...we just have to do our best to hang in and wait. I moved from 6.5 to 6 with only 2 doses of tysabri! (of course i am back to 6.5 without it) I just keep praying that we can all see improvement and more importantly stabilization as soon as possible!
I say,
It's the fire in my eyes,
And the flash of my teeth,
The swing in my waist,
And the joy in my feet.
I'm a woman
Phenomenally.
Phenomenal woman,
That's me.
User avatar
poetriri
Getting to Know You...
 
Posts: 12
Joined: Fri Nov 11, 2005 4:00 pm
Location: South Bend, IN

stock article with GOOD ms patient info

Postby poetriri » Wed Jan 04, 2006 12:02 pm

Here is an article with great risk perspective on Tysabri. Enjoy!


NEW YORK - Ken Kam, co-founder and chief executive officer of the amateur investor tracking and analysis service Marketocracy, recommends buying the American depositary receipts for shares of Irish biotechnology and drug delivery company Elan.

There are two ways to look at the performance of Elan’s ADRs in 2005: They were down 48.9% over the entire 12-month period, but they gained better than 365% off of their March 31 low of $3.00 per share. Elan (nyse: ELN - news - people ) closed Tuesday at $14.01.

Elan lost nearly 90% of its value early in 2005 when it pulled multiple sclerosis treatment Tysabri off of the market in February after the deaths of two patients who had taken Tysabri in conjunction with another drug from Elan’s partner, Biogen Idec (nasdaq: BIIB - news - people ), and developed the rare but sometimes fatal brain disease, progressive multifocal leukoencephalopathy (PML).


Even after Elan has more than quadrupled in value in the past nine months, Ken Kam believes it’s still a good buy since, he says, Tysabri is coming back. On Nov. 17, the U.S. Food and Drug Administration granted Tysabri "priority review" status, which means that a decision on the drug’s return will be rendered within six months instead of the usual ten months.

Kam, who has a background as an entrepreneur and manager in the medical products industry, says two factors that should help Tysabri are that no patients taking just Tysabri came down with PML, and that existing drugs to fight multiple sclerosis don’t work for 25% of MS patients. For those 100,000 or so patients in the U.S., Kam says Tysabri can greatly improve their quality of life.

These facts, according to Kam, mean that there is no good reason to withhold Tysabri from this group of patients. He says the U.S. Food and Drug Administration will use this as their justification for returning Tysabri to the market as a monotherapy with a big "black box" warning about the risk of PML on the label.

“Wall Street is beginning to agree that Tysabri will return, but Merril Lynch and Citibank both recently reiterated their sell recommendations, both citing their belief that Tysabri will be hard to sell to physicians and MS patients until the risks of PML are better understood,” says Kam, who views the pessimism as a buying opportunity, especially in light of heavy “tax-motivated” selling toward the end of last month by people who held it early in 2005 and have “huge losses.”

“Lets look at Tysabri from the perspective of MS patients,” says Kam. “For the 100,000 that are not on any MS medication right now, the choice boils down to this: Tysabri can cut your risk of relapse by 50% without making you feel as if you always have the flu. There is a 0.1% risk of contracting PML if you use Tysabri in combination with other immunosuppressive drugs, but so far, no cases of PML have turned up in patients who took Tysabri alone. To put this risk in perspective, a recent study showed that the mortality risk for aspirin is 0.2%. So an MS patient who is comfortable with the risks of taking aspirin, ought to be comfortable with the risk of taking Tysabri.


“Wall Street expects that Tysabri sales to these patients will be a slow ramp, but, if only 25,000 of them start to use Tysabri, they would generate over $600 million a year of sales, 50% of which would go to Elan,” says Kam, who also sees potential for treating the other 300,000 MS patients in the U.S. with Tysabri.

“One of the common side effects of competing drugs is constant flu-like symptoms. If you caught the flu this winter, you know how miserable it can be. Imagine how it would affect your life if you had the flu all the time. That is what life is like for many of these 300,000 MS patients. An important fact I noted from the clinical trial data and interviews with MS patients is that Tysabri does not seem to give MS patients these same flu-like symptoms.

“For this reason, many of the other 300,000 MS patients who endure these flu-like symptoms may switch to Tysabri, even if it means they have to stop taking their current drugs. If 10% of these patients switch to Tysabri, it would mean an additional 30,000 MS patients that Wall Street is not counting on. So, the potential market for Tysabri may be more than twice as big as Wall Street is expecting,” says Kam, who adds that he is beginning to hear of MS patients on existing therapies who have stopped dosage to clear their bodies in time for Tysabri’s likely release date in the early spring.

“The FDA granted Tysabri a priority review, so a decision is due by March 26, 2006,” says Kam. “We'll see soon enough whether Wall Street is right. If I'm right, Wall Street is in for a big upside surprise.”
I say,
It's the fire in my eyes,
And the flash of my teeth,
The swing in my waist,
And the joy in my feet.
I'm a woman
Phenomenally.
Phenomenal woman,
That's me.
User avatar
poetriri
Getting to Know You...
 
Posts: 12
Joined: Fri Nov 11, 2005 4:00 pm
Location: South Bend, IN

PreviousNext

Return to Tysabri (Antegren or Natalizumab)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users