Two years of Tysabri

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Two years of Tysabri

Postby bromley » Tue Jul 22, 2008 1:31 am

Second anniversary of TYSABRI(R) for the treatment of Multiple Sclerosis 22 July 2008

Biogen Idec and Elan Corporation announced the two-year anniversary of TYSABRI(R) (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS), marking the reintroduction of the product in the United States (US) and the first international approval. The companies estimate that as of the end of June 2008, more than 31,800 patients worldwide are receiving TYSABRI treatment.

Specifically, as of the end of June 2008:

-- In the US, more than 17,800 patients are on TYSABRI commercially and more than 3,100 physicians have prescribed the therapy;

-- Outside of the US, nearly 13,400 patients are on TYSABRI commercially;

-- In global clinical trials, more than 600 patients are on TYSABRI; and,

-- There have been no confirmed cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and the first international approval in July 2006.

Cumulatively, in the combined clinical trial and post-marketing settings:
-- More than 43,300 patients have been treated with TYSABRI; and

-- Of those patients, nearly 13,900 have received at least one year of TYSABRI therapy and approximately 6,600 patients have been on therapy for 18 months or longer.

"Since beginning TYSABRI therapy more than 18 months ago, I have experienced an improvement in my life and how I go about living with my MS every day," said patient Patricia Substelny. "The benefits have been significant in terms of reducing the number of exacerbations I have experienced. I can now confidently work in my garden, cook for my family and friends, and enjoy what life has to offer. I feel very fortunate to have TYSABRI as an option to help me manage my MS."

In the two years since reintroduction in the US and the first international approval, the data continue to demonstrate the benefits of TYSABRI treatment for patients with relapsing forms of MS. Data showed that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of Phase III clinical trials presented at this year's American Academy of Neurology annual meeting. In addition, new data from a patient-reported outcomes survey was presented at the Consortium of Multiple Sclerosis Centers annual meeting showing that after only three months of treatment with TYSABRI, some patients reported improvements in overall quality of life, disease level, functional status and MS symptoms.

Along with TYSABRI's well-established clinical efficacy, growing health economic data from across the globe has been presented and published endorsing the pharmacoeconomic benefits of TYSABRI in MS patients. Based on this data, local health agencies in countries including Australia, Austria, the Netherlands, the United Kingdom, Sweden, France and Germany have all recommended TYSABRI for reimbursement by government-run health agencies.

"During the past two years, my patients who are being treated with TYSABRI appear to experience very positive benefits from the drug," said Dr. Thomas F. Scott, Professor of Neurology, Drexel University College of Medicine and Director, Allegheny MS Treatment Center in Pittsburgh. "Many of my patients tell me TYSABRI is helping them to regain control of their lives."

About TOUCH(TM), TYGRIS and CD INFORM

Before initiating treatment, all US patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis.

TYGRIS (TYSABRI Global ObseRvation Program In Safety) and CD INFORM (Crohn's Disease - Investigating Natalizumab through Further Observational Research and Monitoring) are part of the global risk management plan for TYSABRI. TYGRIS is expected to enroll 5,000 MS patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. CD INFORM is expected to enroll 2,000 Crohn's patients in the US. Patients in TYGRIS and CD INFORM are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.

Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.

Source: SOURCE: Biogen Idec and Elan Corporation
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Re: Two years of Tysabri

Postby HarryZ » Tue Jul 22, 2008 7:43 am

Ian,

You just knew that I would have to make a comment on this press release :)

My opinion of Biogen/IDEC's marketing and sales people remains the same...they are good, slick and can spin information with the best.

"Since beginning TYSABRI therapy more than 18 months ago, I have experienced an improvement in my life and how I go about living with my MS every day," said patient Patricia Substelny. "The benefits have been significant in terms of reducing the number of exacerbations I have experienced. I can now confidently work in my garden, cook for my family and friends, and enjoy what life has to offer. I feel very fortunate to have TYSABRI as an option to help me manage my MS."


One could replace "Tysabri" in this paragraph with LDN, Prokarin, bee stings and many other medications and end up with the same result. Again, good press release material to put on a positive spin

In the two years since reintroduction in the US and the first international approval, the data continue to demonstrate the benefits of TYSABRI treatment for patients with relapsing forms of MS. Data showed that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of Phase III clinical trials presented at this year's American Academy of Neurology annual meeting.


Using the term "disease free" really bothers me here! Anybody who knows anything about MS knows you are NOT disease free regardless of what medication you may be on. They have taken the results of MRI's of the brain to obtain this info and we all know by now how misleading that kind of info can be.

And the cost to patients ( or should we say the insurance companies) is bordering on the absurd! I just read last week that a patient's insurance company in Alaska was billed $ 10,000 for one infusion :roll:

One number that Biogen conveniently forgot to mention...the total number of patients world-wide who are using Tysabri, is 10 times lower than their original marketing plan predicted!

Harry
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Postby bromley » Tue Jul 22, 2008 7:48 am

Harry,

I knew you couldn't resist responding to this.

At least your Biogen shares have increased in value. :wink:


Ian

PS

"Biogen shares rose $1.55, or 2.3 percent, to $68.40 in premarket trading."

Show us you're not as tight as we think you are by treating Lyon, Mrs Lyon and your lady friend to a cruise.
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Postby HarryZ » Tue Jul 22, 2008 10:20 am

Hi Ian,

bromley wrote:Harry,

I knew you couldn't resist responding to this.

At least your Biogen shares have increased in value. :wink:


I just returned from buying several more before the press release :)


"Biogen shares rose $1.55, or 2.3 percent, to $68.40 in premarket trading."

Show us you're not as tight as we think you are by treating Lyon, Mrs Lyon and your lady friend to a cruise.


With the money that Biogen is making on Tysabri, I'm going to trade in my stocks, buy the cruise line and charter the entire liner for you guys :wink:

Harry
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Postby Lyon » Tue Jul 22, 2008 2:05 pm

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Postby carolew » Tue Jul 22, 2008 3:22 pm

May I go on the cruise too? Carole
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Postby HarryZ » Tue Jul 22, 2008 4:09 pm

Hi BOb,

"You guys???" Not to look the gift horse in the mouth but it sounds like you might be a little too good to go on the cruise with the rest of us!


I wouldn't miss it for the world....I was planning to give Biogen sales seminars while out a sea :D

I'm going to be going through London again Friday and Sunday on the way to and from Niagara Falls, NY for my wife's class reunion. I think I've found a way around the long wait at customs....go in the middle of the night!

Bob


Say, if you ever want to meet up for a coffee in London, close to the 401, let me know and I'll be glad treat you.

Harry
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Postby Lyon » Tue Jul 22, 2008 4:23 pm

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Postby HarryZ » Tue Jul 22, 2008 6:08 pm

Hi Bob,

First, I'm sure this conversation is going to draw a "Brokeback Mountain" comment from Ian, but there isn't anything I like more than free coffee!


We'll just let Ian try and figure it all out on his own. :D

Just to make sure, by "coffee" you mean "coffee and donut"....right?


But of course...you may have heard about Tim Horton's coffee shops in Canada (they have expanded into the Michigan from what I hear)....I'll go big time with you and throw in the donut as well :D

As I mentioned, there and back this trip are going to be in the wee morning hours but I'll email you when one of our trips takes us through London at a decent hour.

Bob


OK....I'll look forward to it.

Harry
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