For Tysabri, 23 Is 10 Too Many

Thirteen was a good number for Biogen Idec (Nasdaq: BIIB  ) and Elan (NYSE: ELN  ) .

Twenty-three? Not so much.

That's the number of progressive multifocal leukoencephalopathy (PML) cases that both the European Medicines Agency and the Food and Drug Administration acknowledged have been reported for patients on the companies' multiple sclerosis drug, Tysabri, since it was put back on the market more than two years ago.

The FDA previously said there were 13 cases of the potentially deadly brain infection reported through Sept. 8, so it seems there have been 10 new cases reported since then. Seven weeks doesn't make a trend, but it's still startling nonetheless.

The true rate of PML is very important for the sales of Tysabri. The drug works better than other multiple sclerosis drugs such as Teva Pharmaceutical's (Nasdaq: TEVA  ) Copaxone, Novartis' (NYSE: NVS  ) Extavia, and Rebif from Pfizer (NYSE: PFE  ) and EMD Serono. But patients are only going to use it if the risk of PML is low enough to justify the added benefit.

The European agency has "started a review of the benefits and risks of Tysabri." That might result in tighter prescribing information, but I doubt it'll result in Tysabri being pulled from the market.

Stricter prescribing information might not be the worst thing. Of the first 11 cases -- before Biogen stopped reporting individual cases -- eight were from outside the U.S. even though there were more patients on Tysabri in the U.S. than elsewhere. That may mean that the Touch program in the U.S., which regulates who gets the drug, may be working. If stricter prescriptions result in a lower PML rate, that's good long-term news for Biogen and Elan, even if it means some impact on sales in the near term.

After Friday's beatdown, are the two companies good values? It's hard to know because it's difficult to predict how patients and doctors are going to react to the news. Investors might be better off sitting on the sidelines, at least long enough to see how the prescriptions hold up before jumping in.

Are Elan and Biogen values or value traps at these levels? Let us know in the comments section below.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Elan is a Motley Fool Rule Breakers pick, Pfizer is an Inside Value selection, and Novartis is a Global Gains recommendation. The Fool has a disclosure policy.


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  • Report this Comment On October 27, 2009, at 8:31 AM, amrswid wrote:

    Hi, why so panic? It is still within the 1 in a 1000 limit mentioned in the insert leaflet, moreover, Eu sales only represent 25% of Tyspri sales world wide. You think tighter prescribing instruction worth worrying, may be, but not when dealing with mutipleschlerosis, where no other good alternative, that was evident from 16% growth inspite of previous restictions

  • Report this Comment On October 29, 2009, at 10:54 AM, Fool wrote:

    I read somewhere that patients using Tsyabri had been advised to take breaks from using it & use a proven competitor like Tevas Copaxone for a period of time before returning to use Tsyabri. This if true seems to be a deceptive way of reducing fatalities amongst patients since it doesn't actualy fix Tsyabris inherent fatal fault , its like the use of mercury back in victorian times to cure venerial diseases , used in moderation it was to some degree effective, use too much & its fatal ! I think they should first fix the problem then & only then re-introduce it to the market. Full Disclosure: I own a small number of Teva shares.

  • Report this Comment On October 29, 2009, at 3:47 PM, mcula wrote:

    OK: so let me get this straight.

    You guys say that 13 brain-dead victims of the Tysabri chemical dose is OK... but 23 brain-rot victims is somewhat too many....?

    How about 4 deaths after excruciating painful agony for all involved and the slow rot and decay of a living persons brain organ in jurisdictions where there is no euthanasia available?

    Is this an acceptable situation for Wall Street? Reading your article I would suppose it is cause for humour?

    And for the record, the number of PML Brain-Rot victims is now 24 (since last Sunday evening 25 Oct), as reported today Oct 29 by Reuters: http://bit.ly/1VYVrr

    but by me and others on Monday 26 Oct http://bit.ly/4u8gR5

    If you suggest to wait and see what patients think: then look no further than patients own organisational websites http://chefarztfrau.de/?page_id=418

    [I think it's clear, patients are not happy with Biogen Elan and precisely because of the fact that Investors like Eun Yang [banker and securities analyst with Jefferies & Co.] were aware of the rapid rise in PML Brain-Rot cases yet patients and health-care professionals were still being kept in the dark about the Brain-Rot explosion in those being administered the Tysabri-chemicals.

    Banking analyst Eun Yang let "slip" in the 3Q conference call orchestrated by Biogen Idec on Oct 20th: " We heard recently from your ["inaudible"] that there were a few more cases of PML and so the number of cases around that are around 17. With that said there seems to be an indication between the duration of TYSABRI treatment and PML cases and some doc’s tended to focus on the longer duration therapy, so when you look at the patients who have been on the treatment for 24-months or longer PML rate runs around 1 in 800 which is higher than what is in the label currently. So, my question to you is what do you think would be the critical threshold of a PML rate that where physicians or regulatory agencies would become more cautious on TYSABRI? "

    Mr Yang's question was answered later that week on the following Friday when the EMEA published the "actual" number at that time.

    I communicated earlier this week with a woman whose partner and husband died from PML Brain-Rot last week. She wrote to me telling me how unstoppable the rot is, and that it brings the victim to an ever increasing state of dependence prior to death.

    Survival times are about 4 months, however her husband survived for almost one year.

    http://bit.ly/xsimm

    Also, could we read please here something about how PML is diagnosed. Isn't it diagnosed by locating the presence of the JC-Virus (which is latent in 90% of all humans) "inside" the brain tissue of the victim?

    And aren't brain tissue samples obtained by means of applying large power tools and carefully, once the skull is cracked open, scooping out a piece of live-brain tissue to send back to the lab for testing?

    And wasn't the latent JC Virus discovered in 1971 during experimental processes to induce a state of severe immuno suppression in AIDS / HIV persons?

    What is the connection here. Was Tysabri initially researched for the immuno-supression market belonging to the AIDS / HIV group cohort before the directors decided to "re-brand" it for "the incurables marketplace".

    If that is so, gentlemen, then perhaps it is useful and appropriate to make statements as you do above : after all, it's just a market.

    However, bearing in mind that your pages are accessible to grieving family members : it is highly inappropriate.

    G'day gentlemen.

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