Tysabri info

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

Postby HarryZ » Sun Jun 11, 2006 11:15 am

Ian,

A few minutes a day - even Biogen couldn't come up with misleading figures like this.


You are probably right...they are only getting 1/2 the profit of Tysabri sales. Elan, on the other hand, could easily do it :)

Harry we are all worried for you. As your only true friend on the site - can I suggest that you get your deckchair out and relax. A Budhist friend suggests that each morning you get up and repeat the following "Tysabri is good, Biogen are good". 20 times each morning should be sufficient.


Can I perform chanting instead? :)

I spoke to Arron and we have decided not to ban you from the site. We would welome your postings, on the condition that they are not about Biogen or Tysabri. Welcome back to the fold, I really hope you can comply with this condition - I would hate to see you ejected from this site.


Geez, without Biogen and Tysabri, the board would become a ghost town.

Take care.

Harry
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ghost town?!?

Postby jimmylegs » Sun Jun 11, 2006 12:58 pm

ghost town! my goodness i highly doubt it. i'm thoroughly entranced with this site, and am only looking at this topic, for the first time since i registered earlier this year, because my impatience today won't survive mere hours without looking at a response in a different category than the usual.
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Re: ghost town?!?

Postby HarryZ » Sun Jun 11, 2006 2:25 pm

Jimmy,

jimmylegs wrote:ghost town! my goodness i highly doubt it. I'm thoroughly entranced with this site, and am only looking at this topic, for the first time since i registered earlier this year, because my impatience today won't survive mere hours without looking at a response in a different category than the usual.


You have to understand the tongue 'n cheek responses that Ian and I throw at one another on this forum. The content of these past few messages is about as fictional as one can make them. They are only written to add some humor.

Take care.

Harry
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o i c !!!

Postby jimmylegs » Sun Jun 11, 2006 2:40 pm

haha, coming across such for the first time... i should have known if bromley was involved, there would be something of mischief!
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Ken Kam on Tysabri, Elan Teva & Serono

Postby better2gether » Tue Jul 25, 2006 2:42 pm

.
Ken Kam on Tysabri, Elan Teva & Serono

We are issuing this alert because Élan Corporation, plc ADR (nyse: ELN) fell 5.4% last Friday when two competitors, Teva Pharmaceutical Industries Ltd. (nasdaq: TEVA) and Serono SA (nyse: SRA), joined forces and uncorked another shot below the belt.

In our March Marketscope I said that Élan's competitors would be pulling out all their guns to try to slow Tysabri. Last month the FDA re-approved Tysabri and today, it was re-released to the market. Now as the market is trying to figure out how profitable it will be, an Associated Press report touting a new therapy for multiple sclerosis patients combining Serono's Novantrone, a cancer drug, with Teva's Copaxone, hit the newswires on Friday. The media focused on the 90% reduction in relapse rate for patients in a clinical trial, lending support to Wall Street's doubts that Élan's newly re-approved MS drug, Tysabri, will ever generate significant sales. In an already weak market, the news helped push Élan's stock price down 5.4% in an already weak market to its lowest level in months.

Élan's stock price was already down, driven by a weak market, but the actions by competitors make Élan an even better opportunity to buy.

My Take

Beyond the headlines, however, the rest of the story leads to quite a different conclusion. It turns out that the clinical trial consisted of just 27 patients. Although some of the patients experienced an improvement, one developed acute leukemia. Everyone acknowledges that a lot more work needs to be done, and it's going to take time. A three-year study is just now being launched.

I don't think many MS patients are going to hold-off taking Tysabri, which reduces relapses by 68% and is available now, in the hope that in 3 years, the combination of Novantrone and Copaxone will turn out to be better. As a result, this news should have little impact on Tysabri's launch. But, it seems to have scared a lot of people into selling their stock in Élan just when Tysabri is finally coming to fruition.

Competitors React to Tysabri's Growing Momentum

One way to tell whether a new drug is going to be a success is to look at the reaction of its competitors. It's noteworthy that this story appears first in the AP newswire, not a respected medical journal. That's how you can tell that competitors, not scientists, are behind this story.

There is no doubt in my mind that both Serono and Teva are afraid of the impact Tysabri will have on their sales.

Serono generated $1.2 billion from the sales of MS drugs (primarily Rebif) almost 50% of their revenue in 2005. Copaxone generated almost $1.2 billion of revenue for Teva in 2005 -- about 25% of their total revenue and probably an even higher percentage of their profits.

But Rebif, and Copaxone are only about half as effective as Tysabri in preventing relapses. Neither drug has been shown to slow the progression of multiple sclerosis much less an improvement in disability measures as has Tysabri.

Consequently, both companies have to be concerned that they may lose significant sales now that Tysabri is cleared for sale. From their perspective, the 16 months that Tysabri was off the market was a windfall that enabled them to maintain sales of their existing drugs longer than they expected. Now that Tysabri is back on the market, Serono and Teva are acting as though they are preparing for the worse.

Last year, Serono's board essentially decided to cash out before Tysabri could significantly impact their business. The company hired Goldman Sach's to help them explore "strategic options." Pfizer (nyse: PFE), GlaxoSmithKline (nyse: GSK) and Novartis AG (nyse: NVS) were rumored to be the likely acquirers. However, the Wall Street Journal reported that in spite of Goldman Sach's efforts, Serono had received no serious offers.

In January, Teva acquired generic drug manufacturer IVAX Pharmaceuticals, financing the big acquisition through a $1.25 Billion bond offering by Lehman Brothers and Citigroup during a time when Tysabri was off the market and not considered a threat to Teva's Copaxone. Since then Teva has acted more desperately, trying to reassure investors that Tysabri's growing momentum will not steam roll over Copaxone and affect their debt payments.

Teva seems to be willing to pull out the brass knuckles to maintain Copaxone's sales. On the eve of the FDA Advisory Committee meeting for Tysabri, Bloomberg reported that Teva paid a marketing agent to publicize an unpublished article comparing Tysabri's effect on the human immune system to AIDS. That is a ridiculous comparison. If the best way to protect Copaxone sales is to try to create fear of Tysabri by drawing a ridiculous comparison to AIDS, then Teva must be desperate.

Teva's investment bankers, Lehman Brothers and Citigroup, have also been active. Both firms published research reports citing the risk of PML as justification for their low expectations for Tysabri sales. Coming as it did on the day before the FDA Advisory Committee meeting, these two firms proved that their analysis was not going to change no matter what data was presented at the meeting.

I cannot think of a reason why an analyst making an honest assessment of Tysabri would not want to consider the data that was going to be presented the very next day. I can only surmise that the folks at Teva, and their investment bankers, must believe that Tysabri is a threat to Copaxone's sales. I agree with them.

Competitors often hit below the belt. Whenever a new product threatens to reorder a $5 billion/yr market, you can count on it. Watching Serono, Teva, and their investment bankers take increasingly desperate steps to slow down Tysabri only increases my conviction that Tysabri will be a home-run for Élan.
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Re: Ken Kam on Tysabri, Elan Teva & Serono

Postby HarryZ » Tue Jul 25, 2006 5:12 pm

Better,

Why do I get the feeling that you are a Biogen communication dept employee? That's all we ever see from you are copies of press releases that involve Tysabri.

Anyway....the reaction by Teva and Serono are very typical when it comes to the MS market share drug wars. Berlex, Serono, Teva and Biogen aren't in the business of improving the health of MS patients. It's all about the money and the bottom line and anything that has to be done to protect this, all of these companies will do. If that means slamming the competition's product and saying all kinds of nasty things about it, that is exactly what will be done. All of these companies line up their "experts" to try and give credibility to their press releases.

As Tysabri becomes more and more available at the newly established infusion centers, we can expect these "marketing/sales wars" to heat up. I'm sure that the competition is just waiting to learn of the first case of PML that shows up. They will pounce on that in a flash and make sure the world hears about it.

The cost of doing this kind of business is huge but that's not a problem for these folks....the price of their MS drugs more than makes up for it.

Harry
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Tysabri, Relapses and Disability Progression

Postby Shayk » Tue Jul 25, 2006 7:05 pm

Better--You wrote
Tysabri, which reduces relapses by 68%

Of course, no one wants to have a relapse, but what evidence can you cite that relapses influence or have an impact on long term disability progression in people with MS?

Here's some info I've read about relapses and MS:
The Natural History of MS
These findings demonstrate that the progressive course is independent of relapses either preceding the onset of relapse-free progression or subsequent to it.

Despite considerable individual variation, the progressive course of disability seen in groups of PP, SAP and SP-DSS2 is similarly stereotyped in quality and pace and may entail mechanisms common to all forms of progressive multiple sclerosis. The possibility that this is the primary process in some cases must be considered.

Natural History of MS: A Unifying Concept
the 1562 patients with an exacerbating-remitting initial course and the 282 patients with a progressive initial course of the disease were essentially similar with respect to the time course of disability accumulation from assignment to a given disability score, and the age at assignment of disability landmarks. These observational data suggest that the clinical phenotype and course of multiple sclerosis are age dependent.

Times to reach disability milestones, and ages at which these landmarks are reached, follow a predefined schedule not obviously influenced by relapses, whenever they may occur, or by the initial course of the disease, whatever its phenotype. This leads to a unifying concept of the disease in which primary and secondary progression might be regarded as essentially similar.

Epidemiology and Natural History of MS: New Insights
Natural history studies demonstrated dissociation between relapses and disease progression,

Again, may I ask, what evidence can you cite that the number of relapses is related to long term disease progression in MS?

Thanks for any insight you can shed on the topic as the reduction in relapse rates seems to be a major marketing point of Tysabri. I'm just trying to figure out if it's even relevant data to consider. Clearly, I have my own personal doubts about that.

Sharon
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Re: Tysabri, Relapses and Disability Progression

Postby HarryZ » Tue Jul 25, 2006 8:46 pm

Sharon,

Somehow I doubt that we will see a reply from Better to your questions. I can't recall him ever replying to anyone who has asked him for an explanation to the many press releases that he has posted about Tysabri.

The points you brought up are excellent. Almost every single MS drug trial publishes the numbers that reflect a reduction in the number of relapses and number of lesions as seen on an MRI. Yet, as you pointed out, relapses have little if anything to do with disease progression. And the number of lesions do not correlate with disease progression and symptoms. So although "the numbers" look very nice from a marketing and sales point of view, they don't effect how the disease progresses.

There are people who have used the CRABs and Tysabri and supposedly done well. There are people who haven't used any medications for MS and supposedly done well. There are also those in both the above cases that have done poorly. Personally, I don't think MS pays much if any attention to these drugs and does what it wants and when it wants to.

Most of the progress in MS in the past 20 years is the better way that the symptoms are managed. Beyond that, we still don't have a cause and certainly nothing that comes remotely close to stopping the disease.

Harry
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Postby amelia » Wed Jul 26, 2006 7:24 am

In our March Marketscope I said that Élan's competitors would be pulling out all their guns to try to slow Tysabri.


Regardless of the type of medicine, it is sad that the "bottom dollar" is the motivation to the drug companies. I'm sure it to be so with ALL MS drugs and Cancer drugs, etc.
One is scared they will not get the jump on the other. The heck with all the people that may benefit by it.
Right now, Tysabri is the new drug, albeit much like the CRABs as far as what it targets; taking down the immune system. But for now and time will tell, Tysabri is the one to watch for many MSers
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Postby Arron » Wed Jul 26, 2006 10:32 am

good post Sharon. Relapses are certainly not as "important" a measure of a drug's efficacy versus reduction of disability.

Tysabri offered a 42% reduction of disability in its two year data.
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby amelia » Wed Jul 26, 2006 11:06 am

Tysabri offered a 42% reduction of disability in its two year data.

That is where it matters. And the post that came in with the people who took Tysabri, that had improvements. That is where the hope is. I have come to realize that regardless what shows up on the MRI, the disability is the best measurement. Unfortunately, I don't think the researchers have "got it" yet.
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Postby better2gether » Wed Jul 26, 2006 11:20 am

Harry,

Personally, I don't think MS pays much if any attention to these drugs and does what it wants and when it wants to.



Then how do you explain this post from today from another message board ?

" Just called the Metro Infusion Center near my home; one of 10 MIC offices in the Chicago market. They are among the "official" centers for Tysabri infustions in the Chicago area.

Had a chance to chat with the director there. Very sharp woman, very upbeat and knowledgeable. Herewith is some of the conversation as best I can recall.

Their centers infused Tysabri on the first go round; about 3-4 months before it was pulled from the market. She said they had about 70 patients. Most ALL of them derived TREMENDOUS results in just the 3-4 infusions they had. She mentioned a woman who had been wheelchair bound, and in three months painted 4 rooms in her house! Almost all patients benefitted from Tysabri - amazing results.

When she realized I was knowledgeable about the whole Tysabri saga, and the current status of what is going on, she opened up further. She indicated that most of her 70 patients were floored by having the drug pulled. Many told her they would go to Mexico, Canada, wherever - to get the drug.

Now that it is back on the market - most if not all of the 70 former patients are banging down the door - and many new ones as well. They all know the risk, she said, and feel very comfortable that the TOUCH program has been created to make it even more safe.

She said that MS patients are a very special breed; extremely well informed about their condition, and what is available to help. She is a huge believer in Tysabri, and suspects that their clinics here in the Chicago area are going to be very busy in the months and years ahead administering Tysabri.

Personally gang, I have derived so much knowledge about my investment from this board; but this 5 minute phone call to a hands-on Tysabri professional in my community has just DOUBLED my already strong conviction about my investment in ELN. I am psyched for me, I am psyched for my fellow ELN longs, and I am psyched for the MS patients.

This is NO bullshit - you may want to find an infusion center in your community and see what you can find out. "
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Why I LOVE Tysabri (I'm already married, though)

Postby Ronnie » Wed Jul 26, 2006 11:52 am

Dear Folks:
I am currently taking Copaxone, was on Novantrone for the full three years (finished two years ago); and I also was on Tysabri alone for two months before it was pulled.

I have been calling my neuro office to get info, and evidently the nurses and others in the office were trained on the protocol just two days ago. They will start infusing again very soon! I am on the list...

Meanwhile, the Copaxone pep club ("Shared Solutions") called me last week to make sure I was aware of the "good news" about Copaxone! They are very nice and thoughtful and helpful, you know.

I agree, the fact that I personally know others who were on the Tysabri for several months longer than I who had dramatic positive results, and the fact that I myself felt that I was doing better after just two infusions, does influence my decision to pursue this course more strongly than any of the statistics the pharmeceutical companies deign to feed me. While I was in the Tysabri regimen, I was more stable, had better balance, my eyesight improved, and I had more energy. I want to feel that way again.

I hope I haven't hurt the feelings of the pleasant people working the phones at Shared Solutions.

And, don't let me interrupt the scrapping around. Conflict promotes change, which is important for progress, right?

Take care,
:D Ronnie
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Postby bromley » Wed Jul 26, 2006 12:16 pm

Ronnie,

Best of luck with Tysabri. It will probably be a while before it starts being used in the UK, but a couple of the UK neuros I am in contact with are talking about it in a favourable light. Relapses may not be the best measurement of a drugs efficacy, but drugs which radically reduce the relapse rate (Campath, Mitoxantrone) do appear to provide some stabilisation (at the RR stage) and allow the body a chance to undertake some repair. It is also estimated that there are ten attacks for every one which is felt - so drug such as Tysabri with an average 67% reduction in relapses will also be having an impact on the on-going damage that you don't notice.

Let us know how you get on. There's nothing better than personal experience - we've all had enough of the hype pumped out by all the MS drugs companies.

Ian
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Postby amelia » Wed Jul 26, 2006 12:45 pm

Contrary to what some may say, me and Gary are ANXIOUSLY awaiting his first infusions. ANY improvement is welcomed. We have been looking at the down side for WAY too long now. Time to look up and HOPE again. I love to read what Tysabri did for others. We were shut out within days of treatment. Also, one DR we talked to, mentioned a person that had been bedridden that was able to get up and take steps within a few infusions. Didn't want to mention it before for fear of being hit with skeptisism. I don't know the person but don't have any reason to believe the DR would lie about it.
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