SG Cowen Physician conference call on the launch of Tysabri (Jan 14/2005)
SG Cowen remarks on Physician call
"Physicians Optimistic About Tysabri's Rollout
Conclusion: On Friday, we hosted a conference call with three multiple sclerosis physicians to discuss early trends associated with the uptake of Tysabri. Despite having no clinical trial experience with Tysabri, each physician was well versed in the drug's attributes, considers Tysabri to be
far superior to other MS therapies, and has begun prescribing the drug.
Moreover, early experience indicates few problems with infusion access, adverse events, or reimbursement. Although our conviction that Tysabri will become a multi-billion dollar therapy in MS is strong, we await further visibility on the drug's initial launch before recommending BIIB shares.
Physicians Anxious To Adopt Tysabri. Awareness of Tysabri and its benefits versus other MS therapies is high, while counter- marketing efforts on the part of others have been unconvincing. Each physician has gained infusion access and anticipates 25-30% of their patients to be treated with Tysabri in 12 months. Thus far, infusion reactions have not been observed.
Combination Use With Inteferons A Plus For Biogen Idec. Physicians indicate a desire to maintain patients progressing on beta interferon on background therapy while adding Tysabri. Early trends suggest this approach has been successful in a majority of patients. Use of Tysabri plus Copaxone has been more controversial due to potential antagonism between these two agents.
Reimbursement Smooth Thus Far. Major third party payors have indicated a willingness to reimburse Tysabri (as a monotherapy and in combination with other agents) without any documentation of medical necessity.
However, there has been indication that some patients will face high (20%) co-pays."
The doctor quoted was Dr. Ellen Lathi of the MS Center at St. Elizabeth’s Medical Center,
Tufts University School of Medicine
This is what she had to say about her over 50 infusions :
"Eric Schmidt (SG Cowen)> You’ve probably got as much commercial experience with this drug now as anyone. How has your infusion experience been in terms of infusion-related reactions? Has that matched what is in the clinical database?
Dr. Ellen Lathi > Absolutely. Our two main complaints, and this is no kidding: the first complaint that every patient has is boredom. They all question whether they are getting water. We have seen nothing, absolutely nothing. Patients tolerate the infusion. It’s not even . . they think they are not getting anything. We haven’t had a single headache, a single episode of hives, nothing. And we’ve done follow-up calls the second day with every patient. Now in the trials virtually no one got hypersensitivity the first dose. It peaked at the second and third dose, and even as late as the sixth or ninth dose, I believe. But we have seen now a fair number of people come back for their second dose. And so far we have not seen anything. So people are now .. the other problem that we are having is that people -- not so much the newly diagnosed people who are going to use it as monotherapy -- but people who are further along in the disease who we really feel should be on interferon and Tysabri, and people are coming in begging to come off their shots. People don’t want to continue self-injecting. At least, that has been a common scenario for us, not in everyone. It is so well tolerated that people . . their tolerance for being able to self-inject and tolerate any effects from the interferons, we feel that it has been an issue for us. The drug has been exceptionally well tolerated."
Eric Schmidt> Dr. Lathi, for your patients, for your 50 or so patients, well, maybe you could just talk about how you’re using Tysabri. Is this now “standard of care” in all new patients?
Dr. Ellen Lathi> What we are doing is discussing the data on interferon and Copaxone and Tysabri with every new patient. We are laying it out, we are talking about the "pros" and "cons" of each one, what I said earlier. You know, how I said earlier, one of the advantages of the interferons is that if you stop it or if it is interrupted, it has a longer action. It doesn’t have an immediate discontinuation of its mode of action, all of that. When all is said and done, everyone wants the Tysabri. I mean everyone. People are chomping at the bit for it. I think because of convenience, because of the once-a-month, because people know that there is not the flu-like symptoms. Even our people who don't have much in the way of flu-like symptoms all think that they lose part of a day just from fatigue from their interferon. So people really want it. So, yes, I think most newly diagnosed patients are opting for it. We are giving people choices. And there was an occasion where we have one person who said: “Look, it is too new. I don’t want to be a guinea pig and take something new. I will go for the tried and true.” And we said: “Fine, perfect. Here’s your interferon.” And, after a week, they called back and said “Give me the Tysabri.” So, for most newly diagnosed patients, I think that it is going to be for the vast majority the “standard of care”. But we are emphasizing “You need to stay on it.” I that this it is good, and to me it’s a sound investment, because they do work by completely different modes of action, to me the idea of using an interferon in conjunction with the Tysabri is very appealing although I am also not doing that on newly diagnosed. The only newly diagnosed patients I’m doing that on are people very unstable, people with big deficits at the beginning, people who you just feel are going to be doing badly. But the average MS newly diagnosed patients we are doing Tysabri monotherapy."
Eric Schmidt> .. Dr. Lathi, could you just predict in the next six, twelve and twenty-four months what percent of your MS patients are going to be on Tysabri?
Dr. Ellen Lathi> Well, you’ve got to eliminate the primary progressives, that’s about 10%; you’ve got to eliminate the secondary progressives, that’s probably 35% .. that’s 45%. Then, everyone else -- there will be some people who don’t want it -- probably, of the whole practice, probably 50%.
Eric Schmidt> Within what period of time?
Dr. Ellen Lathi> Um, soon.
Eric Schmidt> And is there any one drug, it sounds as if all of the other drugs, Avonex, Betaseron, Copaxone, Rebif, might be impacted negatively by that gain in share to Tysabri. Is there any one drug that is going to be hurt more than the others in your practice?
Dr. Ellen Lathi> Um, maybe the Copaxone, but there’s a big multi-center trial looking at Copaxone plus Tysabri for efficacy, not just for safety, which has already been done. And I think until that’s out, it is not going to change that substantially. We have more Copaxone people than we do Rebif or Betaseron, I guess. So no, I think it will be across the board. But we actually have quite a number of people coming off their Avonex because they don’t want to take it any more, even if we think ... No, I think all four drugs are going to lose some ..
Eric Schmidt> Dr. Birkmann, could you estimate what percent of your patients might be on Tysabri in the next six, twelve, and twenty-four months?
Dr. Lew Birkmann> I was kind of thinking about that here. I think, maybe 15% within the next six months, maybe 30% by a year and eventually at least half -- and maybe I’m going a little too slow there. I might, based on my own experience, go a little quicker than that and get closer to 50%. But I would say that probably within 2 years, it is going to be close to half.
Eric Schmidt> O.K. And in your practice do you envision any of the existing drugs being hurt more or less by Tysabri?
Dr. Lew Birkmann> Probably, the least hurt, because of the data being available on it the least hurt is going to be Avonex. The other three, I think, will be about equal. And again, I guess I will have to wait until some data comes in on the Copaxone for the trial that Dr. Lathi already mentioned.
Eric Schmidt> Dr. Carlini, can you give us an estimate of your idea of usage?
Dr. Walter Carlini> At six months, I am probably going to be at about 10% of the newly diagnosed, [correcting himself] wait a second, 10% of remitting-relapsing patients will be on Tysabri at the six month horizon. And on the year, I am thinking probably around a quarter of the patients, around 25%. And in two years, again, assuming the data holds up, maybe as much as 50%.
Eric Schmidt> And do you view any one drug as a loser or a winner?
Dr. Walter Carlini> Well, probably Copaxone: simply because that’s the one we have worries about using it in combination therapy for, right now. And again, that’s going to be interesting to see what the results of the trial on combination therapy show.
"Dr. Ellen Lathi> Can I just make one point? This is just anecdotal. But I know three neurologists in our region [Boston] who all have multiple sclerosis. And they are all going on it, for what that is worth. It doesn’t mean anything, I know, but …"