Tysabri info

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

Re: Time to bring back a miracle drug

Postby HarryZ » Thu Sep 22, 2005 5:29 pm

The neurological disorder linked to Tysabri, progressive multifocal leukoencephalopathy (PML), is caused by a common virus that the immune system usually keeps under lock and key. But in all three known cases among Tysabri users it was being tested in combination with another drug. Both are omnipresent and apparently the combination allowed the virus to flourish. Nevertheless, there are NO known cases of PML in patients using only Tysabri, according to the FDA.


It's too bad Michael Fumento didn't do his homework! Nobody knows the relationship yet between Tysabri and PML and what part, if any, other drugs may have played.

As for the warning labels...yes, I agree...too bad Biogen didn't take the time to do their homework because Tysabri could have likely been available to the masses later this year with a warning label. Now they have to take the long route to possibly get this done.

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Re: Time to bring back a miracle drug

Postby DenverCO » Fri Sep 23, 2005 8:56 am

HarryZ wrote:It's too bad Michael Fumento didn't do his homework! Nobody knows the relationship yet between Tysabri and PML and what part, if any, other drugs may have played.


Harry, I'm surprised to hear you say that. You are right, we don't know if there is a relationship between Tysabri and PML, but I'm just surprised to hear you say it.

That may have been an inaccurate statement within the article but the writer was right on the mark in terms of reflecting the position of many (if not the majority of) PWMS.

Michael Fumento, wherever you are, thank you!!!
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Re: Time to bring back a miracle drug

Postby HarryZ » Fri Sep 23, 2005 11:33 am

Denver,

Harry, I'm surprised to hear you say that. You are right, we don't know if there is a relationship between Tysabri and PML, but I'm just surprised to hear you say it.


I'm not sure why you would be surprised to hear me make that statement. From the outset, my biggest peeve with Biogen/Elan has been the fact that they rushed Tysabri into the marketplace after using only one year data from two Phase III clinical trials. In my opinion, they didn't wait long enough to discover what dangers might be presented with this drug even though some prominent MS researches had cautioned them on more than one occasion.

Now the researchers are having to try and find out what connection there is between Tysabri and PML but are doing this after thousands of MS patients had a carrot dangled in front of them with two months worth of Tysabri infusions. Now these patients have to wait for the results and depending on who you believe, it could be for quite some time.

Here is some financial world info obtained from Piper Jaffray:

DATELINE: WEDNESDAY SEPTEMBER 21

"While our recent discussions with clinicians make us less optimistic that Tysabri's return will occur prior to completion of additional trials," said Piper Jaffray. "At a minimum, even if the FDA does clear Tysabri for marketing, we would expect very limited use until more data is provided regarding the risk management of PML [progressive multifocal leukoencephalopathy].

Biogen Idec confirmed that sites involved in previous clinical trials are being contacted regarding possible future studies," according to Piper Jaffray. "We expect additional MS trials to begin by year-end 2005 "Regardless of the timing, it is our impression that physicians will be reluctant to prescribe Tysabri until more information is known about the risk of developing PML--which we currently think will only be obtained through additional trials."

So it depends on where you stand on this as to when Tysabri may be coming back and how available it may be to the MS patient. I'm still not convinced it is as good as Biogen/Elan would like us to believe but that is another discussion for another day.

Take care.

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Re: Time to bring back a miracle drug

Postby HarryZ » Mon Sep 26, 2005 7:47 am

As usual, there are different views on how people think about Tysabri. This news article outlines more or less how I feel about this drug. I don't agree, however, with Embry's comment at the end of the news report where he indicates that nutritional strategies are a viable treatment for MS patients. While nutrition does play an important part in everyone's health, I don't believe one can scientifically state it can be used as a MS treatment.

Harry

__________________________


Death and Dividends: The Tysabri Debacle

By Ashton Embry


For the last three to four years neurologists have been talking about the coming of a much more effective drug for MS. That drug was first called Antegren and then Tysabri. The story of Tysabri illustrates some risky and unsavory aspects of the search for an effective drug for MS.

Tysabri is a humanized, monoclonal antibody that is produced by transgenic goats in their milk. A monoclonal antibody is a designer drug that targets one specific protein in the body and basically knocks it out of action. MS research has led to the concept that MS is driven by activated T cells that are sensitized to myelin. Such autoreactive T cells are activated in the blood mainly through an immune encounter with a foreign protein from an infectious agent or food. The activated, myelin-aggressive T cells then migrate to the brain, pass through the blood-brain barrier and lead an attack on the myelin. It was reasoned if a drug could stop or greatly hinder the passage of these autoaggressive T cells across the blood-brain barrier, then the MS disease process could be substantially short-circuited. Activated T cells cross the blood-brain barrier by sticking on the blood vessel wall and then pushing through it. A monoclonal antibody, which was to become Tysabri, was developed to knock out the protein on the T cells (VLA-4) that allows them to stick on the blood vessel wall.

Preliminary studies indicated that Tysabri was seemingly safe over the short term with a few bad allergic reactions being the only notable adverse effect. By 2001, Elan and Biogen, the drug companies which were producing Tysabri, predicted billions of dollars in future revenue and their stocks started to soar. The Phase III trial began in late 2002 and, after only one year, the companies applied to the Food and Drug Administration (FDA) in the USA to approve the drug despite the fact that there wasn’t any evidence that it slowed disease progression. At the same time the drug was also tested for Crohn’s Disease, a gastrointestinal autoimmune disease, but was found to have no significant effect. One person on Tysabri in the Crohn’s trial died of apparent brain cancer.

In November of 2004 the FDA approved Tysabri for use on the basis of the first year result of fewer attacks and MRI-detected lesions and soon afterwards neurologists were infusing their patients with this new, very expensive drug. The company stocks climbed to new heights.

The last two weeks of February, 2005 were very eventful. On February 14 Biogen director, Robert Pangia, sold 15,570 shares for a profit of $954,844. On Feb 15, Biogen’s executive chairman, William Rastetter, sold more than 120,000 shares, yielding a $7.45-million profit. On February 18 Thomas Bucknum, a Biogen executive vice president and the company's general counsel, sold 89,700 shares for a profit of $1.9 million. Later that same day Biogen informed the FDA that one Tysabri patient had died of a very rare brain disease known as PML (progressive multifocal leukoencephalopathy)and that another patient also likely had the disease.

PML occurs when the JC virus, which most people carry, rises from a dormant state due to a weakened immune system and destroys the myelin in the brain at a very rapid rate. PML is a very ugly disease which usually ends in death over a few months. Given that Tysabri prevents T cells from entering the brain and thus reduces immunological control of the JC virus, it is extremely likely that it is the main cause of the PML.

On February 27, Elan and Biogen issued a glowing press release describing the results of the two-year Tysabri clinical trials. It sounded like the promised drug had arrived. On February 28 the FDA issued a terse statement stating that two Tysabri patients had PML and that the drug was being voluntarily withdrawn from use by Elan and Biogen. Both stocks fell like rocks with Elan losing 60% of its value and Biogen 40%. When questioned about the executives who had possibly made illegal stock trades, Biogen stated "All these trades preceded that quick and decisive action, which was guided exclusively by concern for patient safety and our commitment to the MS community". The Securities Exchange Commission will likely investigate whether or not insider-trading laws were violated.

Throughout most of March it was widely agreed that Tysabri would likely make a comeback as early as the fall. Then at the end of March came the news that the patient in the Crohn’s/Tysabri study who had supposedly died of cancer had actually died of PML. As I write this they are still debating whether or not Tysabri will be brought back despite its potentially fatal side effects.

There are a number of incidents connected with the Tysabri saga that need clarification. It is surprising the Biogen doctors misdiagnosed PML as brain cancer in 2003 especially when PML is a possibility with any drug that has a major effect on the immune system of the brain. Also it is unclear why it took at least a month after the PML cases were identified in the Tysabri and MS trials for the drug’s withdrawal to be announced. This delay put many people at great risk. Furthermore, is it just coincidence that the Biogen executives unloaded their stock during this questionable delay? It is also surprising that Elan and Biogen put out a press release saying how fantastic Tysabri is, knowing full well that the next day the FDA was going announce the suspension of the drug because of ties to a deadly brain disease. And why did the FDA approve Tysabri after only one year of the Phase III trial given the potential of long-term side effects of such a powerful drug as well as the less than stellar results. These are all troubling questions without answers.

Persons with MS should realize that participating in a clinical trial is somewhat like playing Russian Roulette and that a drug company’s desire for maximum profits may compromise their efforts to ensure maximum protection against harm. Drugs that short-circuit the immune system have bad side effects and death is always a possibility. Copaxone and the beta-interferon drugs are cakewalks compared to what is coming down the pipe. The drug companies know that any new “blockbuster” drug, such as Tysabri, has to be significantly more effective than the current drugs and that means they will likely be much more damaging to the immune system.

I always find it incredible that many people recently diagnosed with MS will choose a potentially deadly drug over nutritional strategies that are completely safe and likely more effective. Luckily there are still some people with common sense who do not allow themselves to be sacrificed for profit.
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This article was originally published in the the New Pathways magazine
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Biogen and Elan Submit Sup. Biologics License Application

Postby better2gether » Mon Sep 26, 2005 1:50 pm

26 September 2005

Biogen Idec and Elan Submit Supplemental Biologics License Application to the FDA for TYSABRI(R) in Multiple Sclerosis


CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Sept. 26, 2005--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that they have submitted a supplemental Biologics License Application (sBLA) for TYSABRI(R) (natalizumab) to the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS).

The sBLA includes:

final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX(R) (Interferon beta-1a) in MS;
integrated safety assessment of patients treated with TYSABRI in clinical trials; and
revised label and risk management plan.
The companies have requested Priority Review status for the sBLA which, if granted, would result in action by the FDA approximately six months from the submission date, rather than 10 months for a standard review.

Biogen Idec and Elan will submit a similar data package to the European Medicines Agency (EMEA). This information will be supplied as part of the ongoing review process, which was initiated in the summer 2004 with the filing for approval of TYSABRI as a treatment for MS.

"We are grateful to the MS community for their patience and support over the last several months while we've conducted an extensive safety evaluation of TYSABRI in collaboration with leading experts. We look forward to working with regulatory authorities during the review process, and ultimately, we hope to provide TYSABRI to people living with MS, a disease with significant unmet need," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.

"We are very encouraged by this filing. We strongly believe in the therapeutic benefit of TYSABRI and the difference it could make in the lives of patients with MS. We are committed to working closely with regulatory authorities to define a path forward for TYSABRI as a treatment choice for patients who struggle with the debilitating effects of the disease," said Lars Ekman, MD, executive vice president and president, Research and Development, Elan.

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 subsequently launched a comprehensive safety evaluation in collaboration with leading experts in PML and MS.

http://www.elan.com/news/full.asp?ID=761067
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Tysabri application submitted

Postby better2gether » Tue Sep 27, 2005 6:49 am

From Goodbody

27 September 2005

Tysabri application submitted: new FDA boss looks to streamline.


Perhaps slightly earlier than expected, given the indication six days ago that any such action would be in the coming weeks, Elan and Biogen Idec last night announced after the markets closed that they have submitted a supplemental Biologics Licence Application (sBLA) for Tysabri to the US FDA. A similar package will be submitted to the European Medicines Agency.

The sBLA included the final two-year Phase III data from both the monotherapy (AFFIRM) and dual therapy (SENTINEL) trials; an integrated safety assessment of the patients treated with Tysabri (none showed signs of PML); a revised label; and a risk management plan. They have requested Priority Review status for the sBLA. If granted, this should see action within six months (i.e. before 27 March 2006). We should hear whether the request has been granted in approximately 30 days. This is the next logical step in the road to Tysabri's return to market.

The subsequent, more important, milestone on that road will be the FDA's response to the priority review request. A positive response (action due before the end of October) would imply the FDA remains positive towards the drug and that the data submitted remain compelling.

If any encouragement is needed, the general stance of the new acting chief of the FDA should help. Moving swiftly to fill the gap left by the sudden resignation of the previous head of the FDA last Friday, on the same day, it was announced that Dr Andrew von Eschenbach, the chief of the National Cancer Institute, would be the new acting Head.

Having himself suffered from cancer, he is approaching the post from both a research and patient point of view. He said that the challenge for the agency is "speeding new treatments to the market while ensuring they are safe", but believes that the important questions are "How can we accelerate the timeline?" for drug approval and "how can we ... (get) ... these interventions to the patients as quickly as possible?", noting that "speed does not mean recklessness". A positive approach for Tysabri watchers.

http://www.goodbody.ie/news/morn.html
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Mono-Therapy Will Double Elan

Postby better2gether » Wed Sep 28, 2005 7:29 am

.
Mono-Therapy Will Double Elan


Ken Kam; Marketocracy Marketscope , 09.28.05, 6:00 AM ET


NEW YORK - The single biggest issue that is significant enough to drive a double in Elan over the next two to three years is this: Will the FDA approve Tysabri for use in mono-therapy after Elan pulled it from the market?

We surveyed more than 1,500 members of Marketocracy who put Elan in their virtual portfolios to try to flesh out the answer. Three interesting perspectives emerged from the responses.

The FDA: For the U.S. Food and Drug Administration, the question of whether to allow Tysabri back on the market is one of benefits and risks. The main benefit is that two-year clinical studies have shown Tysabri, when used alone, is twice as effective as any other approved drug in preventing relapses. People who have used Tysabri have actually got out of their wheelchairs.

The main risk is that three patients have come down with a potentially fatal complication called progressive multifocal leukoencephalopathy, or PML--two have died. That's a complication rate of 0.1% out of 3,500 patients. All three cases involve patients taking Tysabri in combination with Avonex from Biogen. Since the three PML cases were discovered, 91% of the patients in Multiple Sclerosis clinical trials that took Tysabri have been screened for PML, and no additional patients have showed signs of contracting it.

There has not been a single case of PML when Tysabri was used alone, but Elan voluntarily took it off the market.

The bottom line is the drug sets the gold standard for efficacy in a disease that is very nasty. Patients want this drug available because it is effective. I expect the FDA will decide that its benefits offset its risks--especially for patients for whom all existing drugs have failed.

Patients, Doctors and Caregivers: MS patients and the people who care for them understand that treating powerful diseases requires commensurately powerful drugs, and they understand that, because of potency, the drugs have potentially fatal consequences for some at-risk patients.

For almost 25% of MS patients, existing drugs have failed to be effective, so many have stopped taking any MS drug at all. Tysabri could be their best option. Most of the remaining MS patients report that the drugs they take do not work well. At best, they slow the progression of the disease, but there is a high relapse rate and many side effects.

So, given the almost 100% certainty of the progressive debilitating effects of the disease, most patients would opt for the rare possibility of PML if they could halt the progress of MS and improve the quality of their lives.

A particularly poignant response I received was: "I participated in the AFFIRM trials and had Tysabri for nearly three years. I forgot what it was like to be an "MSer." Since Feb. 28, nearly all of my most annoying symptoms (itching, fatigue, brain fog) have returned, and I have had my first relapse in about four years."

Biogen: Biogen, the U.S. distributor for Tysabri, also owns a best-selling MS drug called Avonex. Typically, a drug has to be proved effective as mono-therapy before it is approved for combination therapy. Biogen pushed Tysabri's use in combination with Avonex, hoping to convince doctors to prescribe two drugs instead of one. Taking on Biogen as a partner created a conflict of interest.

With FDA approval of Tysabri in combination with Avonex looking remote, Biogen's next-best alternative is to return Tysabri to the market as quickly as possible. As a result, Biogen's interests are now much more aligned with Elan's.

Approval by the FDA of Tysabri for use in mono-therapy by the 20% to 25% of MS patients that have already given up on all other drugs would drive a double in Elan's stock price. Based on the feedback we've received from the people who are in the best position to judge, we believe that will happen. And if any of the remaining MS patients decide to give up on the less-effective drugs they are currently using to try Tysabri then Elan will do even better.

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"Extra" Priority Review will be granted

Postby better2gether » Sat Oct 01, 2005 2:43 pm

Interesting info from another message board.

This post has 355 recommendations

"Extra" Priority Review will be granted

by: lovesjohndory 09/27/05

"As I have posted previously, I was emailed by an FDA official on August 23rd that "the Tysabri submission is slated for a very quick turn-around here." Although FDA has between six and ten months to act on an sBLA after it is filed, with the six month limit for those applications that warrant a "Priority Review," the agency can act more quickly if it elects to invest the necessary resources.

Stealthisalias and I have been assured that the agency has made that commitment, from the Director of the Center for Drug Research and Evaluation, Dr. Steven Galson, to the Deputy Director, Dr. Douglas Throckmorton, to the officials who run the FDA's Office of New Drugs and the Office of Drug Safety, all of whom will be involved in this review. When we met with FDA officials on July 8th to discuss the Tysabri safety review, we were asked to convey to Biogen-Idec and Elan that submission of the full two year efficacy data was essential, as was a proposed risk management plan and revised labeling. We passed that on to senior officials of both companies in conference calls they both scheduled with us following our meeting with FDA, and all of those elements have been included in this filing.

FDA officials are acutely aware that hundreds and perhaps thousands of preventable MS relapses are occuring every month that Tysabri is withheld from the market, many resulting in permanent disability to MS patients. This is a risk every bit as great (and probably much greater) than any potential PML risk in Tysabri monotherapy patients with healthy immune systems.

I expect dosing in the clinical trials to resume any day, once the agency has completed an initial review of the data in the sBLA."
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Re: Tysabri application submitted

Postby HarryZ » Sat Oct 01, 2005 6:06 pm

FDA officials are acutely aware that hundreds and perhaps thousands of preventable MS relapses are occurring every month that Tysabri is withheld from the market, many resulting in permanent disability to MS patients


Hmmm...I guess that doesn't say too much for the interferons or Copaxone these days. They have been releasing longer term, open label studies on these drugs recently and the numbers that they are promoting have been higher than they have ever been in the past. Almost sounds like the marketing wars for that lucrative share of MS medication is starting to warm up all over again!!

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Postby OddDuck » Sun Oct 02, 2005 10:44 am

Yeah, I agree, Harry!

Just when and how did Tysabri suddenly become the ONLY viable treatment for MS?

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Postby HarryZ » Sun Oct 02, 2005 7:39 pm

Deb,

I came across this article tonight that was written in 1992...here is the link

http://jvi.asm.org/cgi/content/abstract/66/10/5726


What caught my attention was the last sentence:

"Our findings indicate that JCV reaches the brain more frequently than previously thought and may persist at this site without causing demyelinating disease. A subsequent episode of prolonged immunodeficiency or a direct interaction with an immunocompromising agent (e.g., human immunodeficiency virus type 1) might activate the latent JCV infection and lead to the development of PML"

notice "immunocompromising instead of immunosuppressive!"

Now just where does that place Tysabri??!!

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Postby OddDuck » Mon Oct 03, 2005 4:12 am

Hopefully, it'll place it (and leave it) off the shelf, Harry (for a patient's own protection). But I know that's probably only wishful thinking!

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The risk to the patients of not having Tysabri available.

Postby better2gether » Thu Oct 13, 2005 1:30 pm

.
Interesting info from another messageboard, about the risk of contracting PML versus the risk to the patients of not having Tysabri available.

This post has 152 recommendations
by: lovesjohndory
10/12/05

"Neuro1111 had a famous post back in April that calculated the approximate number of MS relapses that could be avoided if Tysabri were on the market.

The analysis has been updated, based on the assumption that as of the date it was withdrawn, 7,000 patients were on Tysabri for MS, and an additional 20,000 patients would have been on Tysabri for MS had there not been an insurance backlog.

Using an annual relapse rate of 65% for MS patients on an alternative therapy (about 90% of MS patients) and 70% for MS patients on no therapy (about 10% of MS patients), compared to an annual relapse rate of 33% for MS patients on Tysabri, it can be projected that over the 227 days that have elapsed since Tysabri was withdrawn on February 28th, there have been approximately 10,987 relapses among the 27,000 MS patients that would have been on Tysabri had it not been withdrawn.

Had Tysabri been available to these patients, the number of relapses would have been reduced to approximately 5,535. In other words, approximately 5,451 relapses could have been avoided with Tysabri use by just these 27,000 patients, including an estimated 1,908 patients requiring a use of a cane or wheelchair, and an estimated 899 MS patients who will be permanently disabled as a consequence of these avoidable relapses.

Of course, it is likely that substantially more than 27,000 MS patients would have been using Tysabri. Using the same assumptions, over the course of a full year, with 100,000 patients using Tysabri, approximately 32,567 relapses could be avoided, including 11,398 patients needing to use a cane or wheelchair, and 5,373 patients who would become permanently disabled.

Compare THAT known risk to a potential modest risk of PML, not yet even demonstrated in Tysabri monotherapy patients who are not immunocompromised. "
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Re: The risk to the patients of not having Tysabri available

Postby HarryZ » Thu Oct 13, 2005 5:57 pm

Better.

Using an annual relapse rate of 65% for MS patients on an alternative therapy (about 90% of MS patients) and 70% for MS patients on no therapy (about 10% of MS patients)


Hmmm...I've never been that good at math but reading this message it states that CRAB users only get a 5% benefit over patients who don't take anything!! That would mean that of the approx cost of about $ 18,000 a year for a CRAB, about $ 17,000 would be wasted on a very minimal beneficial treatment. I don't think the CRAB drug makers would be too happy with those numbers...nor would the insurance companies who pay for these drugs.


Compare THAT known risk to a potential modest risk of PML, not yet even demonstrated in Tysabri monotherapy patients who are not immunocompromised. [/b]"


Those two words..."known risk"... keep on coming up, time and time again when we read about Tysabri and its connection to PML. Problem is there was very little known about this risk until two patients in the trials came down with PML and there isn't that much more known about it either at this time. There has to be a lot more research done to come up with the right answers. And Tysabri monotherapy patients who have not been immunocompromised..oh, really...what about the steroids that many have taken over the years as well as the CRAB drugs?

In my opinion, the drug may make it back into the market but under a rather large restriction use. Time will tell.

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Postby bromley » Fri Oct 14, 2005 6:20 am

HarryZ,

I see what you are up to. Keep talking this drug down and the shares of Biogen and Elan will continue to fall. Then you buy up as many as you can afford, the drugs comes back on the market and is a blockbuster, share prices go up, you sell, HarryZ becomes a millionaire. Sorry to have exposed your plan.

:lol: Ian (the artist formely known as Bromley) :lol:
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