Elan at SG Cowen Annual Healthcare Conference

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

Elan at SG Cowen Annual Healthcare Conference

Postby better2gether » Thu Mar 17, 2005 8:49 am

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Elan at SG Cowen Annual Healthcare Conference

March 16, 2005

MANAGEMENT DISCUSSION SECTION

We will get started here. This next session is Elan and I am pretty sure you all know what they are up to. But joining us today, and we were happy his, is CEO Kelly Martin and Head of R&D Lars Ekman, and the way this is going to work is Kelly is going to spend probably about half the session on some prepared remarks. And then we will open it to Q&A then there will not be a separate breakout session. So, turn it over to Kelly.

Kelly Martin, President, Chief Executive Officer, Director

Thank you and good morning everybody. Thank you for your time and for coming today. I am going to talk about two topics. I want to talk about Elan overall for a number of minutes just to make sure that people understand that they are things going on other then Tysabri. And then we
will obviously talk about Tysabri, Dr. Ekman is President of our Research and Development group.
So, during the Q&A you can address questions to either myself, or Lars or above.
Safe harbor statement as some of you heard me speak I don’t read, but you need to read it. In that interest of time, we will move forward. I want talk through a number of topics just remind people little bit of who we are Elan, I think that’s important for myself to explain to people which
constituents we focus on, some thoughts on our progress from an operational point of view, and then obviously talk about Tysabri.

Elan over the last several years, myself in the leadership team and the Board have talked about operational discipline, leading to focus which leads to results. We have an unshakable commitment to patients across our major focus areas, which is never-ending. We have certain tenacity clearly given the challenges we have had in the last two years, three years, Elan, the entire management team, the board has been a very tenacious company in working through a whole series of issues.
Our approach in research is quite different from many others in the industry. We focus again from a research point of view. I am seeking very original approaches to difficult medical problems, be it in Alzheimer's, autoimmune diseases, Parkinson's etc. and the goal of that, which is a very significant goal is by achieving success there, we would have the ability to change the course of disease and how it’s managed. So, it’s a very different approach to what we are trying to get done
from research point of view and how ultimately we align to patients.

The world is getting more complicated not less; that may be an obvious statement but that is certainly the case. We have multiple constituencies that we keep in mind with all that we do. Now we try to balance our decisions that were in the best interest of all these constituencies but first and foremost our patients, payers, physicians etc., we clearly work with all the regulators both in the US and around the world. We have financial constituents both shareholders and creditors, we have partners that we work with, we have competitors that we compete with. Last but not least the Elan employees are a critical part of the future success of the company. So, we spend a lot of time on focus and making sure that we are communicating with them, where we are going and they are giving us feedback as far as how things are going.

Operational discipline, again those of you who heard me speak, I have gone through this over and over again as far as our commitment to make sure we make progress. Just to remind people, we’ve accomplished in the last couple 2.5 years, we had an overhang on both in SEC corporate
finance and enforcement investigation, both were resolved. We had a shareholder lawsuit overhang, which was resolved. We had a California situation which was also resolved. From a financial point of view, starting 2.5 years ago, we had a lot of financial complexity that we wanted to
make sure we resolved, we had alliance obligation which was retired. We had joint ventures all of which have been either closed down or totally endowment. We had two off balance sheet obligations, and one on call EPLES [ph] all have been retired. We are just shy of $0.5 billion of
investments, 90% of which have been monetized. We currently have $1.5 billion in cash and our first that obligation since until 2008.

We will also make some adjustment on our burn rate. We will announce those towards the end of April, I will think that’s the prudent thing to do given some of the uncertainties around Tysabri. We are working to further solidify and reinforce the fact that our operating discipline is resolute good times or bad. We had two broad focuses in auto-generation and autoimmune. That spans from what we do in research through development and regulatory into the commercial aspects of the
company. From a research point of view, from a focus on results, we have one program currently that’s partnered with Vias [ph] who is an outstanding partner that’s in phase two. We have another program that’s partnered with Vias [ph]; that’s pre-clinical. We anticipate that being in the clinic at some point this year.

We have four other programs that are pre-clinical, our current goals and objects are those programs would be in the clinic within the next 24 months. And we have a very, very significant [indiscernible] in the state in this area particularly around all of beta ameloid [ph] topics, which from
a Alzheimer's point of view is certainly a significant part of the future treatment of Alzheimer's. In autoimmune, we have four additional programs that are preclinical and, again the timing would over the course of the next 24 months. Our goal would be that those programs would move into the clinic as well. So, our research department continues to move on and make progress from a focus point of view and the results will speak for themselves over time.
In developments, Prialt was filed and approved in the US. Prialt was filed and approved in Europe, sonogram was filed and improved in Europe, just today it was announced, we sold the asset Aside [ph] but that file was approved today.

Tysabri was filed for Crohn's in Europe. We are doing the induction trial for Crohn's in the US until the pause. We are doing a Phase II R.A. trial. So, our development group has been very active and credit to the team for moving forward and providing specific and significant results to the upward movement [indiscernible].
All the lines, if you will, drug delivery manufacturing has made significant strides in the last 2.5 years, three nanotechnology transactions have been announced, one with Bros [ph], one with J&J, one with Cornie [ph]. Four additional transactions are pending, we have one contractors anufacturing transaction that was completed with Lilly, two others are pending, we have grown revenue per annum in that business 35% of year, per year and the future looks similar from an opportunity point of view, as it relates to growth.

Our US hospital sales force, we have expanded that by 20% over the course of the last two years, we expanded the coverage by 30% IET Hospitals and we have grown that revenue 15% a year for the last two years. So, our base businesses and functions, our research and development have made enormous strides in the last 2 to 2.5 years. Our GS&O, our drug delivery business have made enormous strides in the last 2.5 years, as well as our hospital sales force.

I think it’s important to keep that in mind, we view Tysabri as an event that occurred, that we are working Biogen and the FDA on moving forward, and I will go into some of my thoughts, which regard to that events. But the best for the company continues to move forward, I think it’s very important for us to stay very focused and moving the parts of the company forward that are going to be critical to the long-term success of the company.

So Tysabri, I have a simple slide – this is my only slide on Tysabri, because as it could be either be a 45 different slide presentation or one. Let’s talk about the facts – the facts around Tysabri. First and foremost in the MS patient populations, there are four populations of patients from a trial point of view that have taken Tysabri or we are involved with the MS trials, placebo patients, Avonex, Avonex plus Tysabri and Tysabri mono-therapy. The Crohn's trials, we finished all the maintenance trials and we were in the process of completing the Crohn's induction trial here in the
US and we had also started the Phase II R.A Trial. There were 5,000 patients roughly that had taken Tysabri from a commercial point of view since the end of November, with the approval in the US and there were roughly 3,000 patients currently in any of those trials that I have menioned.

We had two adverse events in one of those patient populations in the Tysabri Plus, Avonex Trial, I will say that to date, there have been no issues found or uncovered in any of the other trials for MS. Obviously, the placebo patients, the Avonex only patients or the Tysabri mono-therapy
patients, there have been no issues to date found in any of the Crohn's data, any of the Crohn's patients and there have certainly been no issues to date in the Phase II R.A patients. So, we had two adverse events in the combination trial with Avonex and Tysabri.

The third set of facts that’s important is to understand the data. Refresher for those of you who may not know, but I assume you all do, but Tysabri was approved in an accelerated fashion by the FDA. It was approved on the one year data that was submitted to them. The efficacy and the
safety profile which is all on the public domain was very significant. The two year data was released at the top line about two or three weeks ago or so and the full data set of two year data will be released April 12th I believe at the AAN meeting in Miami.

For the mono-therapy data, the one year there was 66% reduction in relapses and no significant safety issues. In the two-year data the relapse reduction actually improved slightly to 67% and the all important EDSS score for three months was a reduction of 42% or an improvement of 42% from an EDSS point of view. The data’s important, the data’s critical. The two-year data, I think, will be a very interesting topic of discussion at the AAN meeting in Miami, and underscores the fact that Tysabri from an efficacy point of view is a very, very significant drug indeed. And from a safety point of view, in those categories that I went through currently no issues have been found whatsoever.
I’ll balance that against the patient needs. In MS it was 350,000 patients on drug currently, 50 plus percent of them are what’s known as unstable, i.e., current therapy is not as effective as the patients and/or their [indiscernible] would like it to be and/or the side effects are quite significant.

Addition to that is another 100,000 patients that have already quit therapy for a variety of reasons either the therapy was not effective enough or again the side effects were too severe.
Secondly, Crohn’s patients as you know, have limited therapeutic options, and Crohn’s is a very significant disease as well. Obviously, the focus has been on MS as it should be, but if you look at Crohn’s you look at the patient population, and you look at the medical need the unmet medical
need for the Crohn’s patients, it’s very, very significant. So those are the facts around Tysabri.

Lots of patients through trials, lots of patients have just come in from a commercial point of view.
Two adverse events, very unique adverse events that occurred in patients that were in the combination trial. The mono-therapy data continues to be very strong from an efficacy point of view and as strong from a safety point of view, and the patient population is very significant, focus will need new or better therapy moving forward.

The path forward, working very closely with Biogen and very closely with the FDA. The path forward is as follows. We have committed to do the following things with those 3,000 patients that were in the trials. Roughly 2000 of the 3000 patients were in MS trials, and about 1000 of them
were Crohn’s or R.A. All of those patients will get neurological exams, all of those patients would get physical exams, all of those patients would get there existing MRIs read by central reader. All of the patients would have new MRIs, and they would be read by a central reader. And in certain
circumstances there may be a need for spinal tabs for certain patients.

All 3000 patients will be signed up to do this. We’ve organized again working closely with Biogen on the path forward on this. Current plans have this process taking several months, it’s a logistical challenge to get all of these things done, but I would also tell you that the investigators and the patients are quite enthusiastic as far as getting this done. So that we and Biogen and the FDA can talk about the path forward. The participants in the path forward obviously we integrated and
intimately working with Biogen on all – the same with the FDA about the scientific level and what I will call the policy level keeping the European and other regulators up to speed on all aspects of this, a prudent investigation.

The doctor community, the medical community has had, we’ve had
significant dialog back and forth with the medical community about how to move forward and get their advice and for them to give us a lot of advice about how best to move forward.
We have had enormous response from patients both in terms of e mails, phone calls, in some cases visits patients who heretofore have had less than adequate therapy for their disease, be it Crohn’s or MS and there is an enormous interest on behalf of those patients who are on drug to
help in anyway we can as for as move forward. We have also had a lot of dialog back and forth as you can imagine with the patient efficacy groups and in addition to that, the drug safety monitoring boards for both, for all MS, Crohn’s and R.A. have had a significant amount of dialog.

It's my view from everything that I have seen, again, based on the facts that Tysabri can play a very, very important role in the treatment of MS. The efficacy is spectacular, the mono-therapy safety from everything we have seen so far looks very impressive. We don't know why exactly
there were two patients that had this specific issue in combo. We don't know necessarily if they have to do with combo or had to do with something else. Each of these patients suffice it to say were quite complicated medical patients, they were not straightforward.

So, there is lots and lots of things that we are working again with Biogen and the FDA to investigate thoroughly, to be very prudent on our way forward and upon completion of the process that I just outlined, that I will be hoping to move the product back to availability, to patients, position the right way and in the right way, shape or form.

So, with that, I think the most, the best way to use the rest of the time, another 20 minutes or so, is open it up for Q&A, I am happy to take the questions or I will ask Dr. Ekman to take some of questions and go ahead.
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Elan at SG Cowen AnnualHealthcare Conference

Postby better2gether » Thu Mar 17, 2005 9:05 am

Elan at SG Cowen AnnualHealthcare Conference

QUESTION AND ANSWER SECTION

<A>: Yeah.

<Q>: (inaudible)?

<A>: I will answer the second part and then Lars can do the first part. The second, first of all with regard to patient information, we are in a very – oh, I will repeat the questions, same question or different question. Two-part question, one is compare both patients, any similarities, commonalities and the second patient any further comments on that. So, let me preface these comments by saying something, we are – this is a very unusual situation we are actually discussing patients in
the public arena, this would not be held under any other circumstance that we know of, how these discussion would be occurring. They would normally be occurring between Biogen and ourselves, the FDA and the investigators. So, because of where we are and because of the very uniqueness of this, we can comment on first two patients, but just as a going forward process, we are not going to comment on all of the other patients as we go through this process. It would not be a prudent
thing to do and potentially very misleading to these various constituents that I just went through.
And not in a way that would allow us to do a methodical prudent review of the patients.
So, patient number two, what I can tell you is as follows. The patient is no longer in the hospital; patient has been checked out and is in rehab center. The patient is showing some signs of improvement. When I was told that, I asked the questions, since I know, I doubt anyone else in this
room understood PML two and a half weeks ago. My question then was, I though, PML was a 100% fatal disease or situation and the response is that's not always the case. So, patient number two has checked out of the hospital, number one, in a rehab center; number two is showing some
signs of improvement; number three and was taken off drug in December. Commonality of the patients, if you will ask Dr. Ekman, I can answer some of them, why don’t Lars, you take that?

<A>: It is very difficult without going into the details of these patients. And, we have, how do we not do that. One commonality is that neither case was clear-cut, specifically to the first case, there was a big controversy regarding when the diagnosis was made, what was the right diagnosis, et cetera., it is very clear that from the signs and the symptoms the PML related symptoms started much, much earlier than when the diagnosis was made. The other case which, as Kelly mentioned, got this diagnose much faster, and the prudent action was not taken. I don’t want to go into the specific cases, one of the cases that’s also in the public demand had a malignancy, had an malignancy for which it was treated. That, that, I cannot be more specific without revealing too much of the patients and we should not do that in public domain. Yes next question.

<Q>: (inaudible)?

<A>: Yeah. Second patient.

<Q>: (inaudible)?

<A>: No, I am just going into the facts.

<Q>: (inaudible)?

<A>: I don't know, that's here, which I am sure you might try to see who that is. But, I know, – we know he was taken off drug in December. Yes, all the way back.

<Q>: (inaudible)?

<A>: The question is, from a production point of view as and when Tysabri is back on the market available, where we have enough supply. Well, I can you that Jim Marven and myself, up until the middle of February spent the last 3 or 4 months on supply. Of course, we are looking at the demand curves – Biogen has two plans that are operating today. One in RTP, one in California, the RTP plant is producing Tysabri. As we speak and we will continue to produce Tysabri, as we speak and in addition to that, this pause actually gives us an ability to continue along with some of the engineering work that we are doing in both North Carolina and California. So, that as we need it, that the yield from those plants actually can be up and perhaps quite significantly. So, we continue to manage the supply side, obviously, we have to fix now this regulatory situation, but we certainly are working and making sure we will have enough supply as and when we need it. Yes.

<Q>: (inaudible)?

<A>: The question is how would we determine, if a case is material, it’s a very, very good question, its something that Biogen and ourselves and the FDA are talking about. And its something that we don’t have to answer to, just yet, I know that, I am not speaking for Jim, but I know he and I certainly spoke a lot about this, we can’t be in a position that every time a patient has a temperature, we have to report this, we have thousands and thousands of patients here. Number one, and number two, if you look at other drugs and you look at what happens with patients there isn’t a public discussion of each and every patient, that may have a an adverse events as minor or as major, as it may be. So, I think, that our view is working on the process as it has been put in place, which is you have the medical communities specifically investigators the agency and the companies, you have to take the time to understand, if there are any issues. So, I suspect you will hear less from us, than more going forward. Yes sir.

<Q>: (inaudible). Is there anything mechanistically about affect and mechanistically about Tysabri that was reason to believe that, it was a combination that may have caused this condition, close to (inaudible) modern therapies. And was, is there something mechanistically, about having a, as Mike disclosed this conditions to be developed in the presence (inaudible) today?

<A>: So, the question is, is there a reason to believe that there is a mechanism between the two drugs that could have triggered a, the proliferation of the virus and explosion of the JC virus in the
brand. Well, if you go to the next turn this is the or a, it worked hypothesis and that is that, it is one document that they interfere on, stimulates a down regulation of interferon gamma and then, up
regulation of TDS data. These are cytokines that are, they are potent. That is good when you try to control an MS lesion in the brain. But, at the same point, it is also well known, that these two changes can actually induce virus replication. Now, you will say, why doesn’t that happen in
patients who are on beta interferon. Well, the normal patient on Avonex, they have sufficient T cells surveillance. But, when you have an increased viral replication, you decrease the T cells surveillance in the brain under those circumstances, then you may provocate an uncontrollable
virus replication. These are processes that has been postulated to us from various sources. Then, if you add to that and those of you who follow the chat pages and the web pages on this specific topic, so that over the weekend there was a lot of comments about a paper that referred to the fact that indeed beta interferon induces soluble VCAM [ph]. Soluble VCAM [ph] actually absorbs part of the key cells on top of what is already locked with Tysabri. So, actually you get on almost complete blockers of all T cells surveillance. And then, if you want to speculate and you should be careful by doing that, then you could argue that yes indeed there is a pharmacokinetic event by which a beta interferon triggers a decreased clearance of Tysabri. So, if you want to put an hypothesis, then you
have the terrific storm that could drive a viral replication. Now, that is hypothesis, I am sure many of you could come up with other hypothesis. That is a hypothesis, that we will store and you could argue that there could be other reasons and, but this is one which we have felt being attractive and that we would like to explore.

<Q>: (inaudible).

<A – Kelly Martin>: Yes, the question is, were there two patients on steroids? And the answer to that is yes. And they were not diagnosed simultaneously. All the way in the back, sir?

<Q>: (inaudible).

<A – Kelly Martin>: The question is EMEA and the potential to move forward in Tysabri for both Crohn’s and/or MS. One of our important constituents up here is our regulators. Obviously, Europe is a big part of that. European group has a separate and distinct process from the US. If
you recall, we had accelerated review in the US and the Europeans do not have accelerated review. So, we are continuing along in the normal process in Europe. That has not stopped for both indications. The European regulators obviously now would like to see and hear from us with regard to these two adverse events and they clearly would like to see and hear from us with regard to what we find from the output with regard to the process that were going forward.
I can’t comment on their view, their timing as far as how they are reviewing Tysabri, I can only comment that they are still in their process, they do not have accelerated review. And additionally, particularly for MS, the European regulators were really only interested in the mono-therapy side of Tysabri. But the timeframe and the timelines of the European regulators are theirs, we are continuing down the process both Biogen and ourselves and we are working very hard to make sure that we stick to the timeline as closely as possible. Yeah.

<Q>: (inaudible).

<A – Kelly Martin>: The first question was, did either patient have neutralizing antibodies and the answer to that is no. Second question, with regard to if we find JC virus, what does that tell us in terms of where we find it, in terms of what kind of patients, you know, we have, if those patients are a combination patients that tells us probably a lot. If those patients are R.A. patients, it doesn’t tell us as much and would probably be a bit perplexing. And gain that’s why we are going through this
process – to be has throw and exhaustive as possible, to make sure that we – both companies understand all there is to know with regard to what happened.
Largest [ph] went through a hypothesis of what a fair amount of folks think might have happened.
But I think it will depend very much on which patients we have found anything in and what that would give us. Just to hypothesize, if we found three more patients that all were from the combination trial, that would statistically, clearly give us a zone that we would do extensive – more
extensive work and with regard to various DCs on what is occurring here between the combination of the products. Yeah, up in the back there.

<Q>: (Inaudible)?

<A – Kelly Martin>: Question is PML can be latent specifically the JC virus can be latent for some period of time, and what can we do in the safety trials with regard to that? I can largely expand on it to a degree – but the one thing we are always looking for the regulators, Biogen, ourselves was
opportunistic infections, because we you play around with the immune system that is something that you should prudently look for which we look for. It was 34 or 30? We had 34 of 38 different safety categories that we monitored for all those patients. And obviously we monitored placebo
against drug and in every category throughout all those patient populations this is why the safety efficacy ratio for this drug is so spectacular. There is hardly any change, and in some cases the
placebo patients are worse off than the Tysabri patients in things like depression and other safety issues.
But we didn’t test for JC virus; that is not something that anybody follows. We spoke with you know – Elan invented the Tysabri product in 1990. We have spent over a decade in this area. Our biologists in San Francisco have super sub specialties in all these areas, we have spoken to world
class immunologists for a decade. And I think it is fair to say we are with our Chief Medical Officer for the last couple of days, the JC Virus and or the word PML never came up in any discussion with any group of experts.
Hence that was one of the reasons, when we saw that, we want to take a very prudent aggressive approach with the agency to understand more. So that’s – we are as comprehensive as we can be from a safety point of view, and this is a very, very unusual occurrence, and given that unusual
occurrence, we did what we did. Sure.

<Q>: (Inaudible).

<A – Kelly Martin>: We have had certain people on drugs for more than three years, so the safety beta and the safety trials are as long as we’ve been on drugs. We had certain patients that have been on drugs for almost three and a half years. And they have been monitored against all those things for three and half years. I mean the bodies are pretty complicated thing, there are a lot of other things that could be going on, and it’s often the case for people who suffer from these diseases, they have other things either along with them immediately or they have other things that become along with them as they go forward with their disease.
So the bodies are always changing, and as they change, we continue to monitor from a safety point of view, and that’s how you know we built up over time, safety there [indiscernible].

<Q>: (Inaudible).

<A – Kelly Martin>: The question is a gentleman has a patient, a friend who has in the firm trial who is quite upset about not being having the drug available, we have gotten over a thousand communications a day from patients who are in a similar situation and we understand that, Biogen understands that, and as or more importantly, the FDA understands that. The only thing we can say that those people is given the unusual circumstance, we took this pause to be as thorough and
as prudent as we could to make sure we understood what was going on or at least had a hypothesis that could be proven or almost proven and that we are going to work as hard as we can with the FDA to finish this process as quickly as possible, as thoroughly as possible and to work
with them to get it back to be available to patients. We think we are getting harder in these seven days and we are using all hours in these seven days. So, we are moving as fast as we can.

<Q>: (Inaudible)?

<A – Kelly Martin>: But I think the process will take several months first to finish all these patients.
As regarding to that process, we are also talking to the FDA. So when we get more feedback from them, you know, we will keep the markets posted on that. Over here.

<Q>: (Inaudible)?

<A – Kelly Martin>: Two questions. One is trials, when will they start up again and the second, Dr. Ekman has dangerously educated me on some of the stuff but – first question is trials. We are working with the FDA and going through this process, obviously, trials are very well controlled and
you can make them even more controlled as far as frequency of visits. It’s certainly in all of our interest to restart those trials as quickly but as prudently as possible. It gives you more data, I won’t give a timeframe on it, but clearly from a trial perspective, that would be something that both buyers and ourselves would be very interested in doing as we believe would also be the best interest from an FDA point of view.
On the subset of patients, if you’ll let Dr. Ekman amplify some of my thoughts but there are – it’s a very difficult situation to be in there. Our patients that are MS patients who as we’ve seen from the data, current therapy does not work. They continue to relapse, relapses are permanent damage to the brain and that’s something that we are acutely aware of and the agencies are acutely aware of, maybe specifically they are even before.

<A – Lars Ekman>: No, I am not sure that we can predict in the specific patients, you know, someone who suddenly gets a lesion in their brain stem because you can’t and it’s always not the acute treatment, it’s not the way you use steroids or hypostatic drugs for acute treatment. Neither
of those treatments can be used in order to prevent. However you have to control the disease, we can never predict those patients who have failed current therapy are those who have not been on therapy and those who have break through on current therapy when will the next lesion come, will it hits the brain stem yes or no, will it make you blind, yes or no, and that is the trade off, that the FDA ultimately has to make between the likelihood of PML versus the consequences of the lesions in patients who have no effective therapy and I think that is the key element in this.

<A – Kelly Martin>: Okay, we will go ahead, yes sir.

<Q>: I have another question on Alzheimer’s. (Inaudible).

<A – Kelly Martin>: Okay, well, the question is – there was a conference last week in Italy, it was actually a Parkinson’s focused conference but there was some Alzheimer’s discussion, there was some discussion from external experts about our – the data from our 1792, which we went over the last July in Philadelphia, I am going to have Dr. Ekman go through the details and see he and his are driving all the Alzheimer’s piece. With regard to the beta secret phase topic with Pfizer, we are trying to work through that, they are trying to work through, so we are trying to find a way that we can both move forward with. We are both working on the target and we are trying to get a resolution where we can both on without being encumbered by either or we having good discussion actually with them on that. I don’t if you [indiscernible] for that data.

<A – Lars Ekman>: What was new this week at Parkinson’s and Alzheimer’s conference [indiscernible] in Italy was that, now there is two-year data – hat happens if you can decrease the amount of flex [ph] in the brain, and there is no indication that, yes, your cognitive functions,
effective functions, can be stabilized over time. This is now one and half year almost two years because since we started dosing. We have to remember that even if we dose the patients, we only dose them for part of the trial period, but we can still see the positive effects which is very
encouraging second question, you have was, have we seen something similar with the monotone antibody. Experimentally, we can repeat everything with 70, 92 with the monotone antibody. We do not have that data what you are asking for and with the monotone antibody.

<A>: Maybe a time for two more quick questions. So back here.

<Q>: Can you remind us what the funding arrangement is with Wyeth on the Alzheimer’s product line?

<A>: Funding arrangement with Wyeth is a 50-50 relationship, both funding and resources and input. They are a great partner, we work very well with them, we have done a lot of good things with them and vice versa. So, it’s a very straightforward 50-50 sharing of everything. All way the back, that's where we go, back to you.

<Q>: Question to (inaudible), could you give me some color as to what your PML experience has been (inaudible)

<A>: Right, well the question is let me rephrase the question. But, the question was supposes our PML experts and there was a one particular, I guess, conference in the last few days. Talk about PML for 2 seconds again PML is a very very rare situation, I think, it’s fair to say that there has been a lot of overnight experts anointed with regard to PML, that we have either heard from or read about or in some cases talk too, I will comment on all of the comments from that particular person.
But, I would say that, to answer the facts, the facts are that Tysabri from a data point of view, a monotherapy is a spectacular product. The data also suggests that from a safety point of view, again the way we have monitored it and the way we look at it is, we have seen no issues. It also –
contrast the fact as Lars just said they are enormous in the potential 100’s plus 1,000’s of patients, who have no choice with current therapy. So, as opposed to commenting on this specifics of the latest overnight expert on PML, I think that it’s important to understand those facts. And at the end of the day, Biogen sellers in the FDA will move forward based on those facts not on individual opinions that at least appear to me, to be based on low tax. I will take one more question, then we
will have turn the room. Yes sir.

<Q>: (inaudible)?

<A>: The question is, do I have an opinion, or do we have an opinions on the FDAs decision to halt the trials and other similar agents, I think, it's very logical. It will ill-logical to us, if there is a question or there was something that we need to understand more about Tysabri, specifically and allow the other trials to go on. I don't know, if Lars has any further views on that, but I think, that’s a very logical something that we expected and something that we assumed would happened. So,
with that we appreciate your time, we are very happy to be here and I am sure we will chat with some of you after this.
Thank you.
.
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Postby Arcee » Thu Mar 17, 2005 9:47 am

Thanks for posting. Really interesting. It would be a useful comparison to have transcripts of the upcoming meeting in April where Tysabri will be under much discussion. Hmm.
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Postby Arron » Thu Mar 17, 2005 11:59 am

Fascinating... it seems to be very clear that the company's stance is that A+T is the culprit, and the working hypothesis is plausible. One really must wonder why in the world the scientists at Biogen did not hypothesize this BEFORE spending millions on designing a combination trial that additionally allowed the use of steroids. It is also an interesting question of why OTHER viruses that are omnipresent were not similarly activated if the "only" issue we're dealing with is a severe artificial suppression of the immune system.
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Postby DenverCO » Thu Mar 17, 2005 4:47 pm

better2gether, where do you get the great articles and transcripts that you post here? Did I gather from something that you posted in the past that you work in the medical field?

For those of us anxious for Tysabri's return to the market, I think this information is more reason to expect the re-introduction to be sooner rather than later. I certainly do not think that Biogen would be continuing to pruduce the drug if they expected to have to go back to the drawing board for an extended period of time.
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Postby HarryZ » Thu Mar 17, 2005 9:59 pm

Arron,

I think one reason why Biogen did the A&T combo was for economic reasons. You have Tysabri which is going to shift patients away from using Avonex. So as you increase your revenue with Tysabri, you decrease it by the loss of Avonex sales. Now if you can show that taking both these drugs at the same time can be good as well, that makes your bottom line much blacker!

Harry
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Postby Arron » Fri Mar 18, 2005 12:07 am

i have to agree...
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Postby better2gether » Fri Mar 18, 2005 2:19 am

Denver,

I only try to provide this board with information that I hope is useful for everybody.

Best regards,

Better2gether
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