Temper temper

Be careful about talking about Tysabri in such absolutes. The overall results of the trial were very good, but the best case will not be the experience of all patients.

This board is more for talking, less about arguing or stomping off indignantly, Lauren. Doing that eliminates the opportunity for dialogue.

Well, it seems that despite the marketing/sales efforts of Biogen/Elan and the hype that is being created by some with this drug, the financial world (and that is what big pharma is all about) is being far more cautious as is demonstrated by this press release yesterday:


Like I've said many times, it will take about a year of general MS population use before we start to see any meaningful results from Tysabri.

Harry

And then there is this article found on Braintalk, to consider:

Reuters article of reluctance to use Tysabri

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By Toni Clarke

BOSTON, Oct 23 (Reuters) - Doctors are proving more leery than many had expected about prescribing the multiple sclerosis drug Tysabri, which was relaunched in July after being suspended because of safety concerns.

Over the past month or so, analysts have drawn down their 2006 sales forecasts as it becomes clear that doctors wary of the risk of the rare but potentially fatal brain disease PML are reserving the drug as a treatment of last resort.

The drug, which is made by Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) and Irish partner Elan Corp. Plc (ELN.I: Quote, Profile, Research) (ELN.N: Quote, Profile, Research), had been expected by some analysts to generate sales this year of more than $100 million, but those figures have dropped dramatically.

Ian Hunter, an analyst at Goodbody stockbrokers in Dublin, said on Monday that he has cut his full-year Tysabri forecast to $25.7 million from $78 million, in part because of continuing safety concerns and the complexity of reimbursement systems in Europe.

A survey of 63 neurologists conducted by Reuters Primary Research indicates that in 2006 Tysabri will be used in less than 1 percent of multiple sclerosis patients -- translating into revenue of under $30 million.

Since July, only 47 of more than 8,500 patients treated by the physicians surveyed by Reuters had used Tysabri, even though more than 700 patients had discussed using it, according to the report.

And more than 75 percent of the patients who had used Tysabri prior to its 2005 suspension have decided not to use it since its reintroduction, the survey showed.

In taking the rare decision to allow a withdrawn drug back onto the market, the U.S. Food and Drug Administration was partially influenced by calls from patients who said they were willing to take the risk of contracting progressive multifocal leukoencephalopathy, or PML, because of the potential benefits of the drug"It turns out in real life that a lot of patients and doctors are taking a wait-and-see attitude," said Ben Weintraub, author of the Reuters survey.

About 250,000 to 350,000 Americans have been diagnosed with MS, a degenerative disease of the nervous system that can lead to muscle weakness, blurred vision and, ultimately, disability. Many benefit only partially from current treatments, which include Biogen's drug Avonex.

Tysabri's ultimate sales potential will depend, to an acute degree, on whether there are any more cases of PML, analysts say. Most of the respondents to the Reuters survey said they would stop using Tysabri altogether if two new PML-related deaths were associated with Tysabri.

"Most people say its going to be a $1 billion drug eventually," said Steve Brozak, an analyst at WBB Securities. "But more time is needed. Time buys you information." (Additional reporting by Paul Hoskins in Dublin)

© Reuters 2006. All Rights Reserved.

Good news, that is:
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Biogen, Elan Drug Effective in Crohn's
Tuesday October 24, 9:12 am ET
Biogen Idec and Elan Present Data Showing Effectiveness of Tysabri in Crohn's Disease


NEW YORK (AP) -- Biogen Idec and Elan Corp. said Tuesday data from a long term study of their multiple sclerosis drug Tysabri maintained remission rates in Crohn's disease patients treated over a two-year period.

The study involved 90 patients and showed 86 percent were still in remission after two years of continuous treatment. Also, a subpopulation of 22 patients who had previously taken infliximab therapy showed an 82 percent remission rate after two years.

Rex,

I guess the only concern about Tysabri and Crohn's would again me the lack of long term safety data. The one patient who died from Tysabri monotherapy was a Crohn's patient and the PML started to appear only after a couple of infusions.

Again, it's benefit vs risk and as long as the patient, be it Crohn's or MS, is given all the information about this, the decision becomes that of the patient.

Harry

In all fairness, that patient was already severely immunosuppressed when Tysabri was started. So that's really not a fair case of monotherapy. Nobody has died from monotherapy to date.

Rex,

I know that is a statement that has been made before but in actual fact, this Crohn's patient had stopped using Infliximab 20 months earlier and had stopped Azathioprine 8 months before being hospitalized. Unless those drugs stay in one's system for that huge length of time, the only drug the patient was using at the time of getting PML was Tysabri.

Another note of interest...this patient was relatively healthy at the time of going on Tysabri, only suffering from the problems associated with Crohn's which had been with him for several years. He had been involved in the Tysabri trial earlier but was on the placebo.

Harry

I did not know that Harry Z.

And, let's all remember that Biogen has ethics that have been seen as questionable in th past, so we only know what Biogen tells us, and what they tell the FDA (which sometimes is not the full story).

I'd be interested in seeing a link to that timetable and to the assertion that he had not been immunosuppressed for 8 months prior to being started on Tysabri. I've never read that anywhere.

http://www.medpagetoday.com/Neurolog...erosis/tb/1170