Antegren/Tysabri approved!

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

Postby HarryZ » Fri Nov 26, 2004 10:11 pm

MS,

Am once again feeling a little touchy because you again made a comparison to Vioxx with no just cause. There is no evidence that Tysabri (Antegren) has significantly greater side effects than those associated with the IV itself. Please look at the label.


The comparison to Vioxx wasn't comparing the drug but the drug company's lack of trust in how they conducted themselves. There are experts in the field that are already questioning Biogen's information on Tysabri as being inadequate.

Now, could it have greater side effects? Never say never. But to make the comparison to Vioxx is, in my opinion, not at all fair.


Please read my statement above as to what I was comparing.

And, in terms of efficacy, just look at the Sentinel trial. All patients were already very, very active with EDSS scores significantly above zero, and again the difference between Antegren with beta interferon and beta interferon along was extremely striking. The beta interferon was Avonex, which is the very same molecule as Rebif.


The data presented by Biogen is what is being questioned. They only have one year data and some MS docs are not convinced that there is any efficacy being provided beyond one year. In fact, I was told today that there is a real concern about efficacy beyond 18 months. The people looking at this said they can't verify the data as yet because the trial data simply isn't avail.

I don't object to caution, only the unfair comparisons and the desire to see only those possible questionable issues and to ignore the very compelling data.


Well, compelling data can only be verified when it is made totally available to people outside the Biogen scope and it is data from at least a two year trial. This hasn't been done yet and that's why there is concern and caution.

There are other financial situations taking place as well in Biogen involving the sale of Avonex stock by top execs just prior to Tysabri's approval. Avonex sales will likely drop off significantly now, it's orphan drug status and patent expired in 2003. There will be no cheap generic likely available since the market for it will likely disappear. Tysabri will gain a large market share and it will be sold by Biogen Idec, not Biogen. All carefully crafted in the world of business.

If I were diagnosed with MS today, Tysabri would be my choice and if my physician would not prescribe it then I would find a new neurologist.


That's a decision for you and others to make in consultation with their doctor. But I can tell you right now that there is a lot of doubt with Tysabri and it is coming from people in the established MS world of medicine. I have my opinions about it but they are simply opinions. These people work with MS daily and when they become concerned, it certainly gets noticed soon.
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Postby Ptwo » Sat Nov 27, 2004 4:27 am

Harry, There is no Avonex stock or Biogen stock either. The company's name is Biogen Idec and they are partnered with Elan for Tysabri. I've been unable to find any mention of a stock sale prior to the FDA approval. Can you provide a link? Here's a link you may find interesting.
<shortened url>

You also mentioned that people are questioning the Tysabri data. Can you provide a link for that also? Dr. Throwers statement sounds to me like he's not questioning the data but just the length of the study.

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Postby OddDuck » Sat Nov 27, 2004 7:12 am

When I was doing research on Biogen Idec before Tysabri was released (under the thread "Biogen Idec"), I noted the same thing that Harry is referring to...........the amount of stock being sold and moved around by Biogen Idec's top management. That much stock "activity" of any sort by top management of a corporation raises a red flag.

Here's what I mused about in that other thread:

EDIT: Oh, yea, and their big-wigs have been moving around stock like crazy. That much inside stock activity doesn't bode well. Whenever you see that, you can bet there's a hidden agenda going on. Check out the amount of SEC form 4 filings they've been doing lately.


If you go to the Securities and Exchange Bureau (it's hard to quibble with their data, as it is mandated under law and filed by the companies), you will see the amount of form 4 filings that have been filed and by whom.

http://www.sec.gov/cgi-bin/srch-edgar?t ... ode=Simple

Also, on Biogen Idec's own website under their information for investors section, you can find where they have posted their own SEC filings there, also.

It's not hard to find...............

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Postby Ptwo » Sat Nov 27, 2004 7:50 am

Thanks Deb, I'm not familiar with the world of stock options and the forms involved but it looks to me like some were buying and holding while others were buying and selling.

I guess the theory is if they're selling they know something the rest of us don't and they think the stock has peeked. I'm not so sure that's the case.

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Postby OddDuck » Sat Nov 27, 2004 8:01 am

I guess the theory is if they're selling they know something the rest of us don't and they think the stock has peeked. I'm not so sure that's the case.


Well, I don't know that I'd put it down to just "selling" stock that indicates anything specific, just that most times (in my experience) when stock activity and maneuvering around is sort of "active", especially by the upper management, it just raises a red flag.

Usually (when "watching the competitor" for strategic purposes), when we see that kind of activity at all, we consider it an "alert" and then tend to keep an eye on what the competitor might be doing and more importantly, "why".

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Postby HarryZ » Sat Nov 27, 2004 9:13 am

Peter,

Harry, There is no Avonex stock or Biogen stock either. The company's name is Biogen Idec and they are partnered with Elan for Tysabri. I've been unable to find any mention of a stock sale prior to the FDA approval. Can you provide a link?


I believe that Deb has provided the answer to your question.


You also mentioned that people are questioning the Tysabri data. Can you provide a link for that also? Dr. Throwers statement sounds to me like he's not questioning the data but just the length of the study.


I receive a lot of email from various sources re: MS. Some of it I can provide links and sources and some of it I can't....I am specifically requested NOT to post this info until such time as it can be verified. I will write something quite generic in these cases or say nothing at all. In the case of the Tysabri data being questioned, I and you will have to wait. Dr.Throwers comment is only part of the info that I received, in confidence.

Some people feel that the posting of info on internet forums should follow strict guidelines in that everything should be verified or linked. ...more or less like it is in a court of law. Others don't share this opinion. With my information, the readers can either choose to believe what I post or simply treat it as hearsay (some of it actually is) . That's up to the reader to decide. I can only personally say that I have never knowingly mislead anyone on the net for the past 5 years in my participation on several MS forums..

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Postby MeadowStream » Sat Nov 27, 2004 1:10 pm

Harry,

The data that is publicly available is excellent both with respect to safety and efficacy. The side effects are benign compared with those of ABCR treaments.

You are right about www.msworld.org or www.braintalk.org and others requiring substance behind claims. That seems like a reasonable standard. But, ThisIsMs does not require this level of substantiation and that is OK. But, more weight will be given to opinions whose basis is not top secret and available only to the author. A claim like. "The drug is only effective for 18 months," cannot possibly have any real basis since the 2 year data is only now being wrapped up and any 18 month data would take a good 6 months to analyze.

MS
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Postby HarryZ » Sat Nov 27, 2004 1:51 pm

Peter,

I finally found the link about Biogen execs selling their stock. The info is part of a press release by Teva who have not surprisingly started the war with Biogen for MS drug market share. Of course, the article is very slanted in favor of Teva and Copaxone.

Harry

http://www.globes.co.il/serveen/globes/ ... did=857686
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Re: sources

Postby HarryZ » Sat Nov 27, 2004 2:07 pm

MS.

The data that is publicly available is excellent both with respect to safety and efficacy. The side effects are benign compared with those of ABCR treaments.


That's where the opinion differs I guess. The people that wrote me were not impressed with the current data available and stated that it was anything but excellent. I don't pretend to be anywhere near an expert when it comes to properly reading these trials but other people do know how and it's these people who are expressing concern.

A claim like. "The drug is only effective for 18 months," cannot possibly have any real basis since the 2 year data is only now being wrapped up and any 18 month data would take a good 6 months to analyze.


Well, I think you may be wrong on this one. Tysabri has been in clinical trial use for about 4 years now and there would be some 18 month data available. I'm going to assume (and that's a dangerous word to use these days) that the info obtained by these MS experts had this data about the 18 month efficacy in it. I wasn't given that kind of detail as yet but you can be sure that a number of scientists are going over whatever data is released with a fine toothed comb. Like I've said, I don't for one minute pretend to be an expert on this....I rely on others to give their expertise about Tysabri and other MS drugs.

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18 months

Postby MeadowStream » Sat Nov 27, 2004 3:07 pm

Harry,

There has been one 6 month PII trial and two 2-year PIII trials. There is no data for 18 months available outside of Elan and Biogen. If your sources are Biogen and Elan insiders then that is one thing, if not then I think it is safe to assume that the people expressing their opinion about 18 month data are guessing at best: not even the clinicians know which patients are receiving Tysabri since the PIII trials have not yet been unblinded.

As far as Biogen-Idec insider sales go, there are two points to make. Firstly, insider sales do not correlate to company performance. Insider buys do, however. Secondly, Biogen-Idec has a lot to lose as well as gain: Tysabri will cut all ABCR drug market share numbers significantly, even Avonex's and Avonex has the 2nd best efficacy/side effect profile on the market. Only Elan's stake in Tysabri's and no insiders have sold shares for almost 3 years (since a single director sold almost 9,000 shares.) http://finance.yahoo.com/q/it?s=ELN That is an amazing statistic and if Tysabri data were smoke and mirrors then a very different table would appear at that link.

Instead of panning Tysabri, why don't you stack it up against the ABCR's and note the discrepancies.

MS
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Postby Ptwo » Sat Nov 27, 2004 3:26 pm

Harry, thanks for the link. I guess the folks who were guessing why Biogen big wigs were selling their shares were a Little off the mark. (several Biogen executives have sold shares recently, giving rise to assessments in the market that the FDA's response would be negative.)

On backing up your information, it just seems like a good idea to me Harry. Folks come to these web sites looking for information so they can make life changing choices. It's possible that someones unsubstantiated claim could change a persons coarse of therapy and maybe their lives.

Most people I've talked to are going to stick with their current treatments for now, I'm going to continue my Copax every other day routine. The one exception I know of is my niece who has very aggressive ms. Her lesions heal very quickly but she makes new ones just as fast. She's hoping that Tysabri will slow things down.

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Re: 18 months

Postby HarryZ » Sat Nov 27, 2004 7:55 pm

MS,

There has been one 6 month PII trial and two 2-year PIII trials. There is no data for 18 months available outside of Elan and Biogen. If your sources are Biogen and Elan insiders then that is one thing, if not then I think it is safe to assume that the people expressing their opinion about 18 month data are guessing at best: not even the clinicians know which patients are receiving Tysabri since the PIII trials have not yet been unblinded.


You could be right....or you could be wrong! I'm only going by the information that was sent to me and that source has been quite reliable in the past. After all, MS docs and scientists do talk to one another!

As far as Biogen-Idec insider sales go, there are two points to make. Firstly, insider sales do not correlate to company performance.


This information was sent to me today. I haven't read the article in the Wall Street Journal but I have to believe that it appeared. The person's own words were added to some of the facts of the article so this isn't a quote.

In a Wall Street Journal article it is reported that just shortly before it was expected to get the FDA approval, Biogen released only part of the study results--the part that Tysabri showed a 66% effect in decreasing relapses. But they held back the information on how Tysabri compared to Avonex. Now everyone knew that this was being tested, and they also probably expected that if the results showed poorly for Avonex that the results wouldn't be published, after all that it is the norm. I'm sure the Biogen stock holders didn't expect to get slapped in the face. Of course they got slapped twice, in that the Biogen Execs released a small bit of promising information prior to the approval, and people anticipated that Tysabri used in conjunction with Avonex would have even better results, so the Biogen stock value soared and the Biogen Execs were then able to sell their stock at inflated prices and all the time knowing that Biogen stock was going to drop shortly when the results of the FDA approval were publicized showing that Tysabri and Avonex were not any better than just Tysabri alone. Yet Biogen Idec stock would greatly jump.


Instead of panning Tysabri, why don't you stack it up against the ABCR's and note the discrepancies.


Good grief, why would I compare anything with the CRAB drugs?!!! I have a well established reputation on the MS forums as one who has no use for the CRABs. I can remember a number of years ago my wife's neurologist comment to her about possibly taking one of the CRABs....he told her to take two good holidays a year instead of spending the money on one of the drugs....and she would very likely feel a lot better in the long run!!!

I'm sorry MS, from what I have read and been told about Tysabri, I simply can't support this drug in any way. I have gone over my reasons in previous posts and I don't want to repeat them again. I realize that numerous MS patients are very excited about this drug and I really hope that my opinion about it is totally wrong. But my info is coming from people who know a heck of a lot more about MS than I do and that is what has formed my opinion.

Harry
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Postby HarryZ » Sat Nov 27, 2004 8:07 pm

Peter,

On backing up your information, it just seems like a good idea to me Harry. Folks come to these web sites looking for information so they can make life changing choices. It's possible that someones unsubstantiated claim could change a persons coarse of therapy and maybe their lives.


Yes, you are right about the back-up. Normally I save most of the articles that I quote but there have been so many in the past few weeks that I sometimes have a problem locating them. At the same time, I would hope that a person with MS or any major disease, wouldn't be making a big decision on their health based on reading one article on the internet. I make it a habit of never telling a person what drugs to take or not to take if I am asked specifically by an individual. I always recommend that the person obtain all the info that they can about a treatment, consult with their doctor and then make an informed decision. Of course, like you said, the chance of someone not doing this and making a decision based on one comment is possible!

Most people I've talked to are going to stick with their current treatments for now, I'm going to continue my Copax every other day routine. The one exception I know of is my niece who has very aggressive ms. Her lesions heal very quickly but she makes new ones just as fast. She's hoping that Tysabri will slow things down.


I'm thinking that if your niece's MS is that aggressive, it is either PPMS or SPMS. If that's the case, then I doubt they would use Tysabri on her..

And I hope you continue to do well on the Copaxone.

Harry
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Postby Observer » Sat Nov 27, 2004 9:52 pm

Good points all around.


If I may, I'd like to state some facts and my comments/interpretation of those facts.

1. The FDA approved Tysabri.

They must have been in possession of ALL the data, in particular all the data that is non-public and not yet published. I expect that they would have conducted an extremely thorough and scientific analysis of all the data. Also, the two year trials are or nearly are fully complete. Again, the FDA would have asked the companies for a review of all available 2yr data on efficacy, safety, etc before approving the drug. Why wouldn't they?

I think Meadowstream is wrong in saying that only Biogen (Idec) and Elan are in possession of the 2yr data - I'm convinced that the FDA has these data also. Its also important to consider the mechanics of drug trials - you don't have 1000 people all of a sudden starting at the same time and completing the trials on the same day - there is a considerable stagger - with some staring months before others. The early-finisher data would most certainly be available for review, and you can bet your bottom dollar that the FDA has looked at it!


2. Vioxx withdrawl affected the FDA.

With the Vioxx scandal looming large, wouldn't the FDA be much more diligent in performing their tasks? I would guess they would. They must have went thru the data with a mircoscope, IMHO.

Harryz stated "The one year data that they have taken that 66% rate from is already suspect!" I don't know what is suspect, but this statment suggests the FDA has been duped or ignored something. Is this what is being said or implied? IMO that's probably way off the mark. But who knows? Certainly not me.


3. Data release in peer-reviewed journal will take 1+ years before available.

People are concerned that the data have not been released in a peer-reviewed journal. First, the trials are not yet complete (at least data analysis is not complete), and then the results must be written-up and submitted for peer review. This entire process could take 6-12 months. Take a look at Antegren's P2 results - published in NEJM in Jan, 2003 yet the trials were complete 1+ years before then.


4. Comments about 18-month efficacy reduction has no data supporting it and is simply a rumour.

I can find no substantiation of an 18 month reduction in efficacy, or anything about the basis (theoretical or experimental) for such statements. It is odd, however, that this is the same as the Vioxx time that heart problems appear with Vioxx.

Without data, why does this rumour continue to be perpetuated? Data please - proof, and then I'll change my 'fact' above.

Ditto with the 'rebound effect,' which was suggested in P1 but was disproven in Phase 2.

Bottom line: Would the FDA have ignored any data existing which suggested an 18-month efficacy drop or a rebound effect? I think not. IMHO it is fair to conclude, in the absence of any proof, that there is NO 18-month efficacy drop or a rebound effect. If the 2 yr data show otherwise, I would be very, very surprised.


5. The FDA thinks the data are very strong. This is from their press release:

"This innovative treatment for multiple sclerosis represents a new approach to treating MS -- exciting news for patients with this serious disease," said Dr. Lester M. Crawford, Acting FDA Commissioner. "While we eagerly await long-term results from ongoing clinical trials, we have reason to believe that Tysabri will significantly reduce relapses in MS."

The approval of Tysabri is based on positive results seen in patients after one year of treatment. This product received accelerated approval because it appears to provide substantial benefit for patients with a serious disease. As part of that approval, the manufacturer has committed to continuing its trials of this product for another year.

I have seen no one, except CRAB makers, criticizing the data in print. I am not a statistician, but the data look very good to me.


6. Elan insiders have sold NO stock for 2+ years.

Wonder what that says about Biogen Idec insider's concerns about Avonex sales. I think it says a lot, but who knows?


BTW, I'm positive on Tysabri, though am not an MS sufferer. Just call me an interested observer.

That's my view.

Great board and discussion.
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Postby Observer » Sat Nov 27, 2004 10:51 pm

I want to make one more post, then I'm going away again. This will comment on a couple of Harryz's posts. (And by the way, we all should thank him for the effort that he puts into this and probably other boards.)

First, the comment use of Tysabri in SPMS

I'm thinking that if your niece's MS is that aggressive, it is either PPMS or SPMS. If that's the case, then I doubt they would use Tysabri on her..



I am not a doctor so I cannot comment on whether it is possible to use Tysabri in PPMS or SPMS, however, Tysabri certainly seemed to work VERY well against the aggressive form of MS suffered by the 5 yr old little girl. See

http://www.thisisms.com/modules.php?nam ... opic&t=598

As a laymen, I will speculate that it may very well work on SPMS, but that the data are not yet sufficienly robust to make that claim in the drug's label. The companies have not yet tested the drug in full-fledged clinical trials on SPMS (the current trials were only on RRMS patients).

Furthermore, as Harryz correctly points out, whether it would be effective would certainly be something for the patient and physicians to judge and act upon.

Now, onto a statement that I feel must be challenged:

So do you see how the study was manipulated to show benefit according to their measurements of effect. Of course I wish people would pay more attention to the real issue here as they boldly state "The exact relationship between MRI findings and the clinical status of patients is unknown. Changes in lesion area often do not correlate with changes in disability progression." So what is the point in using this criteria to determine if a drug is going to have any effect on a MS patients life?!!


First, the study was designed and all protocols were agreed with the FDA. IMHO, the charge of manipulation is unfounded (as you'll see from my other comments below), but the reader can make their own judgment.

Second, the bold statement that MRI findings and clinical status of patients is simply a fact, and all of the drug makers and the FDA agree that this is a fact.

Third, the FDA and many physicians believe that MRI findings ARE clinically significant, its just tying them to disease progression that is unknown.

Now, a couple of comments on the 'basis' for the above 'manipulation' statement, which came from someone whom Harryz communicates with and is supposedly knowledgable about MS Research. I will quote from Harryz's post.

First of all the patients who were in Study 1 had a disease duration of 5 years versus the patients in Study 2 had a disease duration of 7 years and consequently the percentage of relapse change is significantly different between the two Studies. Furthermore, the patients in Study 1 which Biogen has been boasting that it showed a 66% decrease in relapse rate, most likely had a very low score on the EDSS because "approximately 94% had never been treated with these agents (interferons or copaxone)" but of course they don't bother to tell us what the median EDSS score was in this group. They only tell us that patients were enrolled that had an EDSS score between 0 and 5.0. Most likely the majority of these patients were closer to 0 given that 94% had never received any treatment. (My comment: I believe that Serono alluded to this lack of information in their recent press release on Tysabri.)


Comment: The FDA and Biogen Idec/Elan agreed that EDSS scores would be the primary endpoint of the 2yr P3 study, and that 1 yr data are too early to assess improvement in EDSS scores. My problem is that the poster is criticizing the companies for not reporting something which the Companies never intended to report at year 1. The primary endpoint of Year 1 was relapse, with the MRI as secondary endpoints.

I don't understand the criticism in the quote, but I do note that the writer makes assumptions about the data, stating twice 'most likely.' It is generally not good to make assumptions when analysing data.

Next if you look at the tables in Figure 1 you will see that under MRI Endpoints it says that the median number of new or newly enlarging T2 lesions was 0.0 for the Tysabri group in Study 1 meaning that no new lesions were formed. Well since no new lesions were formed then that means that 60% of patients put in the Tysabri group never had any lesions to start with because it states that 60% of patients in the Tysabri group in Study 1 had no lesions.


I assume that the quote refers to Figure 1 (actually, Table 1) from the label information on Tysabri:

http://www.tysabri.com/downloads/produc ... mation.pdf

First, 'median' is a sample statistic which means half of the sample are less than the median value, and half of the sample are more than the median value. It is important to know this, therefore, new lesions could have indeed formed, while some lesions may have gone away.

Second, note the Table 1 footnote, 'MRI endpoints by ordinal logistic regression adjusting for baseline lesion number.' We do not know how many lesions the patients had prior to the study, but it is quite possible that many/most patients had lesions (since that is one of the tools used to dx MS.)

Third, the label did NOT state that 60% of patients had no lesions at the start of the study, it stated that 60% had no NEW lesions during the course of the study. There is a very important difference, and 60% of the Tysabri arm NOT developing new lesions verus 22% on placebo who did not develop new lesions certainly suggests Tysabri was effective in reducing lesion load (which was the study secondary endpoint).

I don't know how this can be viewed negatively, nor how the above supports the charge of 'manipulation.'

Readers might find it interesting to consider the definition of median. If the 'median' is 0, might there be some patients with reduced baseline lesion load? That is, not only no NEW lestions, but some of their study-start existing lesions were actually cleared. This is interesting, but I remind all that it is an ASSUMPTION.

Now more tell-tale is the Gd-enhancing lesions (active lesions) because the median in both the Tysabri group and the placebo group in Study 1 were 0.0, meaning no change from before they entered the study. This shows that 96% of the Tysabri group in Study 1 had no active lesions, but the placebo group had only 68% with no active lesions prior to the study. The Tysabri group had only 3% with 1 active lesion prior to the study, yet the placebo group had 13% with 1 active lesion prior to the study. The Tysabri group had only 1% with 2 or more active lesions prior to the study and the placebo group had 19% with 2 or more active lesions before the start of the study.


First, MRI endponits were adjusted for baseline lesion number. The statement that some had 'no active lesions prior to the study' cannot be made since we do not know what the baseline was. Indeed, all of the conclusions in the above quote are quite possibly based on a false premise, since we do NOT know the baseline lesion load ('lesions prior to the study.')

Again, how does this support any 'manipulation.'

Study 2 is just more of the same.


This dismissive tone is disappointing, but is suggestive of the author's bias.

I just don't agree with the 'manipulation' charge nor that the statements above support that charge. In sum,I don't know how the Tysabri trial results can be viewed negatively.

I hope these comments are useful and help to provide a different perspective on the Tysarbri results.
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