Biogen deal for PML

[Arcee]

from the Boston Globe

Alnylam, Biogen to partner on brain disease treatment
Alnylam Pharmaceuticals Inc. of Cambridge said it will collaborate with Biogen Idec Inc. to develop a treatment for a rare brain disease found in three patients taking Biogen Idec's multiple sclerosis drug Tysabri. Alnylam said Biogen Idec, also of Cambridge, would fund research to find a treatment for the disease, progressive multifocal encephalopathy. Alnylam will receive $5 million upfront and could earn up to $51 million if a drug is developed and sold. (Jeffrey Krasner)

[HarryZ]

Arcee,

from the Boston Globe

Alnylam, Biogen to partner on brain disease treatment
Alnylam Pharmaceuticals Inc. of Cambridge said it will collaborate with Biogen Idec Inc. to develop a treatment for a rare brain disease found in three patients taking Biogen Idec's multiple sclerosis drug Tysabri. Alnylam said Biogen Idec, also of Cambridge, would fund research to find a treatment for the disease, progressive multifocal encephalopathy. Alnylam will receive $5 million upfront and could earn up to $51 million if a drug is developed and sold. (Jeffrey Krasner)

Jeffrey Krasner is a newspaper reporter who has been following the Biogen/Tysabri story for many months.

I find it interesting that Biogen has teamed up with a pharma company to look for a treatment for PML. Wondering if they expect a number of cases to show up in MS patients who use Tysabri.

Harry

[bromley]

Harry wrote:

I find it interesting that Biogen has teamed up with a pharma company to look for a treatment for PML. Wondering if they expect a number of cases to show up in MS patients who use Tysabri.

This seems a sensible move to me. PML cases were seen in the trials and nobody knows what the risk of developing PML is in the long term (for Tysabri patients). Given this uncertainty, it seems prudent to be able to offer those taking your drug, and who develop PML, a treatment.

Ian

[HarryZ]

Ian,

This seems a sensible move to me. PML cases were seen in the trials and nobody knows what the risk of developing PML is in the long term (for Tysabri patients). Given this uncertainty, it seems prudent to be able to offer those taking your drug, and who develop PML, a treatment.

Ian

The reason I found it interesting is that Biogen/Elan have said for months and months that the risk of contracting PML when using Tysabri is very rare. Yet they have made this recent move and didn't appear to issue any press release about it. The only reason that we have seen it is because of Krasner, whom from what I know, doesn't like Biogen at all and constantly follows them when it comes to Tysabri.

You know me when it comes to Biogen...

Harry

[bromley]

HarryZ,

You and I both know that the reason they are doing it is to make sure they can keep selling Tysabri. If PML cases were to pop up after a couple of years, this modest investment might result in a way to treat PML, keep the patient alive for more Tysabri, and make sure that Tysabri isn't pulled for being too risky.

It would really piss me off if for $50m, this company came up with an effective treatment for PML (a severe demyelinating disease - MS' even badder cousin), given that Biogen, with their billions, cannot come up with an effective treatement for MS.

Ian

[Arron]

Ian, it wouldn't surprise me... PML has a definitively known cause, and thus potentially obvious routes to explore in treating it. It seems to me that detecting it is the more difficult challenge and would always be an issue.

It's a $50M insurance policy for a billion dollar drug. Biogen has numerous drugs for MS in the pipeline (Rituxan also has a link with PML), so this may unfortunately be a handy tool to have around.

[bromley]

Arron.

You're right. They know that the JC virus causes PML. It's strange that they can identify the cause of a rare demylinating disease like PML, but can never get to the bottom of a much more common, and very heavily researched, disease such as MS. But of course there is no money to be made with a rare disease which is usually fatal. Whereas there are billions to be made from a chronic disease lasting 30-40 years (as long as you only tackle the easy bit and convince people your drugs slow down the disease progression)

IanZ (in honour of my adopted father Harry)

[HarryZ]

Ian,

IanZ (in honour of my adopted father Harry)

Well sonny....I'm starting to feel my years all of a sudden

Papa Harry

[euphoniaa]

The first thing I thought when I read this was, "Wow! If this drug works, they could cash in on the PML fear and probably give patients both drugs at once!" I've noticed that the latest craze in the world of clinical trials is to try giving patients TWO expensive, modestly effective meds at once or to double the dose of one of them.

Even though it may take awhile to finish trials and get approval for a PML drug, the publicity alone will encourage use of Tysabri - patients thinking well, even if PML starts turning up in a couple of years, at least there will be treatments.

SusanZ (Harry's younger, prettier sister)

Hiya, Harry.

[euphoniaa]

Yay! I got another post through! When I find a thread that doesn't dump me, I feel like I've gotta keep posting.

Ian, I believe the reason they can't come up with 'A' drug for 'A' disease is that it's not 'A' single disease. My personal opinion is that it's more of a combination of diseases, unique to the individual.

You know that not a single one of us fits smack dab into the middle of the MS paradigm, as it's commonly described. Until they start tightening the criteria to identify subsets of patients for research purposes, they're not going to learn much about the disease. It's a given that a certain percentage of patients in any drug trial don't even have MS (whatever that is).

Or maybe they have another medical condition that affects the course of their MS. I have a whole host of additional diagnoses, myself.

Enough of that. Maybe I should save my speculative manifestos for another thread.

[HarryZ]

SusanZ (Harry's younger, prettier sister)

Hiya, Harry.

Yikes...my family is growing before my very eyes

Harry

[bromley]

Harry,

Here is Biogen's press release. I'll send you £100 if you can spot the word Tysabri in it.

Ian

http://www.biogen.com/site/019_0.html?p ... PR_141.htm

[HarryZ]

Ian,

Here is Biogen's press release. I'll send you £100 if you can spot the word Tysabri in it.

Biogen has one of the better marketing depts in the business. You don't think they would allow any possibility of connecting Tysabri and PML in this press release?!! Your 100 pounds are very safe

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare

After reading that part of the release, I think I need a stiff drink!!


On a sad note, we had to put our 16 1/2 year old cat down today after she suffered a severe stroke. Going to miss the little "fur-ball".

Harry

[msladyinca]

Why am I not surprised that more defaming remarks and crappy inuendos (FUD) are still being spread against Tysabri by certain posters???

I find it interesting that Biogen has teamed up with a pharma company to look for a treatment for PML. Wondering if they expect a number of cases to show up in MS patients who use Tysabri.

PML found in 5:62 patients receiving Rituxan, manufactured by Biogen. Special notation as in the wording "of viral infection" in which the article is specifically talking about PML. Can we say add another case of PML to Rituxan and note there is no question mark! In other words we now have 5 cases of PML in 62 patients and none in the control group-w/o Rituxan. The study illustrates PML in the 20 month from treatment. Special Notation Once Again as there is now evidence to counter claim BiogenIdec's wording of Viral Infection up to 1 year from last infusion as PML has surfaced 20 months from Treatment The stats are 12.4 % for PML if treated with Rituxan for this disorder-"We recently observed 2 cases of progressive multifocal leukoencephalopathy and a case each of CMV retinitis and pneumonitis occurring in lymphoma patients 9, 20, 5, and 12 months after". First link below is for the 4 PML cases; 2nd link is for the 5th PML case.
http://www.bloodjournal.org/cgi/content ... 104?ck=nck http://www.bloodjournal.org/cgi/content/full/99/4/1486

That's why Biogen is trying to find the "cure" for PML...it has absolutely nothing to do with Tysabri.

Need I remind everyone that PML was not found in one single MS patient in over 8,000 patients that received Tysabri as a monotherapy?

Give the scare tactics a rest guys....Ignorance isn't always bliss, it just means that some of you appear to be more ignorant than others.

Sheesh. If anyone wants more info on this subject, send me a PM please.

[HarryZ]

Lauren,

Why am I not surprised that more defaming remarks and crappy inuendos (FUD) are still being spread against Tysabri by certain posters???

Dr. Lawrence Steinman, one of the inventors of Tysabri, has said on more than one occasion that this drug was going to cause problems such as PML. He warned Biogen, prior to FDA approval, that they were going too fast to get the drug into the market for MS patients. Other researchers also stated the drug was marketed too quickly before any kind of long term safety data was completed. Would you call their comments "defaming" as well?

Biogen made a total mess of introducing the drug for MS patients and that is the main reason that you are finding it an absolute mess in trying to get approved to use it. The docs and clinics that will eventually use it have to cover every possible angle to prevent any possible legal action against them.

Biogen screwed up, now MS patients are paying the price. At the same time they are going after a PML solution which the experts say is going to happen again with Tysabri. It may be better to concentrate your energy on getting approved for Tysabri as opposed to worrying what I say about Biogen. My opinions aren't going to change your mind about Biogen nor are they intended to. And nobody else is going to change their mind either after reading what I write. They are opinions, nothing more.

Harry