Elan's Investor Conference Call Notes Regarding Tysabri
Some notes from Kelly Martin's remarks on Tysabri during the Elan 4Q Conference Call:
" Last topic is Tysabri. Let me go through sort of a basic framework of how we want to make sure that this is positioned. Biogen had their call yesterday. You will find that what we say and what they say are consistent around Tysabri across the board. Obviously, this is an asset of huge strategic importance to both companies. And it is something that we stay very close on.
A quick update on the launch. We got approval the end of November. We’ve roughly had 9 weeks of marketing opportunity in the marketplace. And in the first 9 weeks I think it’s fair to say that the uptake on Tysabri from a patient point of view has far exceeded our thoughts and Biogen’s thoughts and it looks like it will continue to do so. In the first 9 weeks we have upwards of 3000 patients currently on drug. And in addition to that, in the queue so to speak, there is a multiple of that number who are waiting to work through the system to get on therapy.
Additionally, Biogen and ourselves targeted roughly 6000 neurologists around the U.S. Roughly a third of those neurologists have already written or prescribed Tysabri. Again, that’s far in excess of what we thought, where we thought we would be from a penetration point of view and a share of mind point of view with the medical community.
The patient composition: it’s too early to go into either projections or decomposition of what we’re seeing from a patient point of view given that we only have 9 weeks, roughly, of data. I think it’s fair to say that the patients that we have on therapy today have come from all different categories: some who had been on therapies, some who had quit and some who are newly diagnosed. I think that is a logical extension of what you will probably see in those 2000 neurologists’ practices. As we get more data, and as we can decompose the patients on therapy and the patient demand, we will have more and more information from the marketplace with regard to what the patient composition looks like.
Timeline of Tysabri: we would anticipate that MS and Crohn’s, that we would potentially be able to launch those in Europe towards the end of this year. We would be hearing from the agencies towards the end of this year with a launch soon thereafter. Rheumatory arthritis: the Phase II data is available by mid-year this year. That’s obviously an important thing for Biogen and ourselves to look at in anticipation for possible uses of Tysabri in Rheumatory arthritis. And our Crohn’s induction trial: we will have the data from that at mid-year and again, based on the data, would be involved with discussions with the FDA soon thereafter. I will also say, in addition to all of that activity across Europe and the U.S., Biogen and ourselves are in discussions about further life-cycle planning. There are multiple other indications that Tysabri would appear to be very attractive for. And we are managing with Biogen sort of the next wave of things that we should focus on.
Manufacturing is critical. Jim Mullen, the CEO of Biogen, and myself talk frequently about the supply-demand management since the demand side of the curve is something that we learn as we go. The one thing that we know is that we have to manage those two things very dynamically. Biogen, to repeat, has a plant in North Carolina that has been producing Tysabri and will continue to produce Tysabri as we speak. At the same time, there is a plant in Oceanside, California that is being, has been completed and will be up and running sometime in ’06. And lastly, there is a plant, a third plant in Denmark that in early ’08 or ’09 looks like it will come on line from a production point of view.
It’s important to remember in manufacturing that Biogen is doing a great job in making sure that engineering changes and process changes, all of which can be incorporated into these, firstly, the first two plants, are being looked at and being incorporated. And as those engineering changes get, take hold, the production and patient count in each plant will rise potentially quite significantly.
Two critical factors that we have looked at, again, with Biogen, are infusion capacity and infusion capability. Our view is that in the U.S. market infusion capacity is ample. The infusion industry, which I have said a number of times, is an industry unto its own. And it’s a very quickly adapting and changing industry. So be that in a doctor’s office or be that in a hospital or away from both, the infusion capacity and the agility of that industry is something that we are seeing. And therefore, infusion is not a gating factor for us as far as the continued uptake of Tysabri.
The second topic that we have described a number of times is reimbursement. The reimbursement system in the U.S. is cumbersome. It’s a new product. There are hundreds and hundreds of private payers whom we are working with. We are making progress and we will continue to make more progress. And this is a topic that as we go farther along in the launch process, the better and quicker the reimbursement discussions will get. And as and when we get the reimbursement process automated, obviously that will be a acceleration of uptake from a patient point of view.
The good news is from a reimbursement point of view is that in the last nine weeks roughly 3000 patients have managed to go from seeing their neurologist to getting prescribed for Tysabri, to getting their infusion and to figuring out with our help and others the reimbursement structure. So we are making progress; we will continue to make progress. What is important to know for Tysabri in MS in the U.S. is the groundswell of interest amongst patients, among neurologists, seems to be very broad, very deep and is gaining momentum every single day."