9th PML... where's the info?

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

9th PML... where's the info?

Postby Meegs » Sun Jun 21, 2009 7:07 am

So i got a Google alert yesterday for this:
http://www.reuters.com/article/marketsN ... 0820090619

I love how it talks most about the $ being made and not about the patient.

As a Tysabri patient, shouldn't we be kept apprised of these situations?
i've only got 3 infusions in me but PML is obviously still the elephant in the room when i'm getting it.

If I called the TOUCH program (Tysbari's patient care here in Canada) would they be able to give info on the 9th case?

Just wondering.... going for #4 in 2 weeks.
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Re: 9th PML... where's the info?

Postby HarryZ » Mon Jun 22, 2009 6:09 am

I love how it talks most about the $ being made and not about the patient

You have to understand that big pharma is not in business to worry about the concerns of MS or any other kind of patient but to make as much money as possible. It's all about the bottom line and not patient health. Unfortunately, that's simply the way it is.

Biogen is no different...in fact, their product info is not exactly the most trusted in the medical field. That comes from a neuro I know and not from me although I totally agree with his comment.

Biogen had originally thought that Tysabri was going to be a blockbuster drug and predicted it would pay for itself within 18 months of its original release. We all know the roller coaster ride the drug has had and revenue estimates are immensely lower than planned. So you won't hear too many comments coming from Biogen where the info isn't supportive of adding more sales for Tysabri.

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Postby cheerleader » Mon Jun 29, 2009 8:47 am

10th PML case

By Thomas Gryta

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) reported that a 10th patient on its multiple sclerosis drug Tysabri, sold with Elan PLC (ELN), has developed a rare brain infection, the fourth such report since mid-May.

A suspected link to progressive multifocal leukoencephalopathy, or PML, led to Tysabri being pulled from the market for 18 months beginning in 2005. Prior to Friday, the company has reported that nine people had confirmed cases of PML, with one dying, since the relaunch.

BIIB closed Friday up 8 cents to $50.07, while ELN rose 9 cents, or 1.2%, to $7.36.

The drug was allowed back on the market in 2006 because of its effectiveness in fighting the degenerative disease and the PML incidence remains below the long-projected risk of one in 1,000 patients developing the infection.

The patient with the latest confirmed PML case took 30 doses of the monthly medication and was located overseas. Only two of the 10 cases since last July were located in the U.S.

Much is unknown about PML, but it is thought to be caused when JC virus, which most people carry, attacks the central nervous system in those with weakened immune systems, often leading to an irreversible decline in neurologic function and death.

It's thought that Tysabri patients with PML have had a better prognosis because of earlier detection and treatment with plasmapharesis, a process that removes large molecules from the blood, speeding up Tysabri's removal and allowing the immune system to fight the infection.

Tysabri is one of several immune system suppressing therapies that have been linked to PML, including Rituxan, sold by Biogen with Roche Holding AG (RHHBY) unit Genentech, and Raptiva, a psoriasis drug that Genentech pulled from the market earlier this year because of the issue.

Earlier this year, Biogen retreated from its long-held goal to reach 100,000 patients on Tysabri by the end of 2010. As of the end of March, about 40,000 patients were using Tysabri, up from 37,600 patients at the end of December.

Some believe that duration of therapy plays a role in Tysabri's risk. About 6,800 patients have used the drug for more than two years, as of the end of March.

Biogen is posting a case update on the Internet every Friday at 4:30 p.m. EST until July 24 - the third anniversary of the drug's relaunch - by which time it expects the risk/benefit profile of Tysabri to be clearer.

Tysabri had 2008 sales of $813 million, but longer-term sales trajectory, which is key to Biogen's future growth, will depend on the true incidence of PML, which is still coming into focus.
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PML case

Postby screamner » Mon Jun 29, 2009 12:03 pm


That's a well informed german blog.
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Re: PML case

Postby HarryZ » Sat Jul 04, 2009 6:20 pm

Read an interesting comment about Tysabri the other day. Per Biogen, about
6800 patients have been on the drug for 24 infusions. In this group, there have been 6 cases of PML with the last 3 happening relatively close to one another. You start to wonder whether length of treatment may effect the risk of incidence. Let's hope not!

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