Tysabri info

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

Postby HarryZ » Thu May 25, 2006 5:00 pm

Dunman,

Dunmann wrote:Just to add more fuel to the fire... Elan is thinking about increasing the price of Tysabri.



Well, that didn't take too long...did it?!! The wholesale cost of the drug now is US $ 1803.00 per infusion. Early users reported total infusion costs ranging from $ 2300 to over $ 5000, easily making Tysabri the most expensive MS medication on earth. I'm sure the insurance companies won't be very impressed at whatever the new cost will be.

Hey Ian....maybe I should have purchased some stock in Biogen and Elan after all. :D

Harry
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Postby amelia » Fri May 26, 2006 7:13 am

We all know that Tysabri is NOT the miracle cure. But if you are legally blind and it gives you back some sight, then it is the only miracle on the block. Betaseron and Copaxon, the 2 CRABs that Gary took, NEVER improved anything. They both did limit his attacks, which were miracles in themselves. Betaseron quit working because of the antibody thing, which shut him out of other interferons and Copaxon seems to have lost its usefulness. Hince, he is better off than on it. Gary's digestion slows up from time to time. He has had many spinal attacks. I don't mean he gets constipated. That is just about all the time. But he can eat a meal and it will takes DAYS for him to process it. Now that becomes a problem. He gets bloated and sick at his stomach. Other than adding some enzymes to him, there really isn't much you can do about that. BUT if Tysabri improves that just a little, then it is a miracle. I am tired of all the hoopla of this and that. I am ready to see its return. You know, it might not do a DANG thing, but it might. I don't worry about price because I'll give my eye teeth if I have to for Gary. I just want him to have the right to take it. I'm tired of hearing how bad it is when there are WORST things on the market. I just feel if the FDA had MS it would be back yesterday.
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Postby bromley » Fri May 26, 2006 7:15 am

Harry,

I think you got it right with your investment in Teva, as Copaxone is selling like hotcakes! MS is a growth industry and your investments are paying dividends. A cure may be just around the corner, but you'ver made enough to spend the rest of your life on a beach in Bermuda.

Ian :lol:
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Postby HarryZ » Fri May 26, 2006 7:32 am

Ian,

bromley wrote:Harry,

I think you got it right with your investment in Teva, as Copaxone is selling like hotcakes! MS is a growth industry and your investments are paying dividends. A cure may be just around the corner, but you'ver made enough to spend the rest of your life on a beach in Bermuda.

Ian :lol:


Heck, I didn't invest in Teva....not after The Cochrane Group came out with their report that Copaxone was all but useless in the treatment of MS.

But don't you just like the reasoning behind Elan's planned price increase for Tysabri....because the competitors are going to raise the price of their drugs for MS!!!

I knew I should have placed my life savings with these companies...guaranteed profits :)

Harry
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Tysabri Conference Call Highlights

Postby better2gether » Wed Jun 07, 2006 5:55 am

From NCB Equity Research Morning News & Views

Tysabri Conference Call Highlights

• To clarify some confusion in the market, BiogenIdec stated on the joint CC with Elan that there was nothing in the label that precludes first-line use of Tysabri. When the prescriber and patient agree, the label allows the use of Tysabri in treatment naïve patients (first-line use), as the FDA has recommended but not limited use of Tysabri to patients that have failed other therapies. An estimated c.15K-20K patients are diagnosed with MS annually.

• Tysabri is expected to be available in the US in July 2006. Over the next few weeks the FDA is expected to finalise educational/training materials and BiogenIdec/Elan will validate internal systems based on final FDA requirements. Once internal personnel are trained, infusion centres can be registered. At that point, BIIB/Elan expect that it will take 2-10 weeks before patients are administered Tysabri with reimbursement possibly taking some time although they do not anticipate substantial issues surrounding reimbursement. BIIB/Elan will target the 2000 infusion entres in the US and 2,500 neurologists through the c.220 person sales force. In Europe, a decision on Tysabri's approval by the EMEA is also expected in the July timeframe which will lead to a country-by-country roll-out starting in Germany with roll-out in other European markets in H1 2007.

• The price of Tysabri will be disclosed closer to the launch of the product. With the two year Phase III data now included in the label, it seems likely that Tysabri's price will increase from the $23.5k.

• In terms of the RiskMap there is nothing substantially new incorporated into the risk management program from that discussed at the advisory committee meeting in March 2006. The goals of the RiskMap are to ensure
(i) that patients are fully informed about the risk of PML;
(ii) that early detection of PML can occur and
(iii) that data is continually assessed so that the factors associated with patients developing PML can be made.
The companies anticipate that rumours will surface over the coming quarters about suspected PML cases and they will only comment on fact based cases.

• In the label, no "wash-out" period has been recommended for patients on current MS therapies or for those on immunosuppressants. This could see patients potentially having quicker access to Tysabri than previously thought. Elsewhere, the 70K patient supply capacity at BiogenIdec's North Carolina plant was re-affirmed with the potential to increase this capacity to supply 100K patients. The high-titre process and the facility in Denmark are not anticipated to be in use until 2008. Our peak sales forecasts of $1.8bn assume use of Tysabri in c.65K patients.


Orla Hartford+353 1 611 5844 orla.hartford@ncb.ie
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Re: Tysabri Conference Call Highlights

Postby HarryZ » Wed Jun 07, 2006 6:41 am

• The price of Tysabri will be disclosed closer to the launch of the product. With the two year Phase III data now included in the label, it seems likely that Tysabri's price will increase from the $23.5k.


Well folks, guess who's going to pay for the 18 month hibernation of Tysabri? Bigoen/Elan mess up the introduction of this drug into the market place and MS patients (I should say their insurance companies) will pick up the tab!!

• In the label, no "wash-out" period has been recommended for patients on current MS therapies or for those on immunosuppressants. This could see patients potentially having quicker access to Tysabri than previously thought.


Hmmm....it seems that for the past 18 months, Biogen/Elan have defended the safety of Tysabri by stating it is just fine as long as it is used as a monotherapy. In several press releases, we have heard that the PML problems only surfaced when Tysabri was used in conjunction with other immunosupressive drugs. The Crohn's patient's death was blamed on that patient having a severely compromised immune system (which really wasn't the case )even after stopping those drugs for months before going on Tysabri. And now we read that there is no "wash out" period being recommended before the MS patient starts on Tysabri! Put in mathematical context....(Tysabri) - (no wash out) = (quicker access) > (original revenue prediction)

Don't you just love how Biogen/Elan have the MS patients' best interests 8O

Harry
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TYSABRI® Pricing

Postby better2gether » Fri Jun 09, 2006 1:13 am

.
TYSABRI® Pricing

TYSABRI® (natalizumab) will be available upon the completion of key activities related to the risk management plan, including finalization of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel. As such, Elan and Biogen Idec anticipate TYSABRI will be available in July.

The wholesale acquisition cost is $2184.62 per vial.

Elan and Biogen Idec are committed to making TYSABRI accessible to appropriate patients who may benefit from therapy. To achieve this goal, programs have been developed to assist patients who are uninsured or who require financial assistance. Patients who require financial assistance can receive more information by calling MS ActiveSource at 1-800-456-2255.

http://www.elan.com/Products/united_sta ... ricing.asp
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Re: TYSABRI® Pricing

Postby HarryZ » Fri Jun 09, 2006 5:57 am

Better,

The wholesale acquisition cost is $2184.62 per vial.


Not bad....about a 20% increase in price over the original cost. I guess Biogen/Elan really are "committed" to making Tysabri available to those who want to try it.

I guess SOMEONE had to pay for the additional costs related to getting this drug back into the marketplace :roll:

Harry
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Postby bromley » Sat Jun 10, 2006 2:03 am

Harry,

This is basic economics - any company would do the same if they were launching a new product and it was deferred by a year, and then the target audience was more restricted than previously thought. Given the drugs in the pipeline, Tysabri might have a limited run so the company needs to recover its costs (developments, production etc).

If Tysabri provides a better quality life to some MS sufferers, I'm sure the extra 20% will be money well spent.

It's also better for Biogen shareholders such as yourself. :wink:

I have another theory that you applied for a job at Biogen, got rejected, and never forgave them! :lol:


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Postby HarryZ » Sat Jun 10, 2006 5:50 am

Ian,

This is basic economics - any company would do the same if they were launching a new product and it was deferred by a year, and then the target audience was more restricted than previously thought. Given the drugs in the pipeline, Tysabri might have a limited run so the company needs to recover its costs (developments, production etc).


Problem is, Tysabri isn't a new product and it wasn't deferred for 18 months...it got pulled because of a potential danger to users. This drug got rushed into the market before it should have been and now MS patients (insurance companies because nobody could begin to afford it on their own) are being made to pay for the short-comings of Biogen/Elan. Charging about $ 40,000-45,000 a year for a drug that hasn't really proven itself yet!! Geez Ian, with your line of thinking, I'm going to nominate you to the Elan Board of Directors :)

If Tysabri provides a better quality life to some MS sufferers, I'm sure the extra 20% will be money well spent.


I'll tell you exactly where the extra 20% is going to go...into the pockets of the shareholders and bonuses for the upper Biogen/Elan execs! Do you really think that these companies are going to use this extra revenue to conduct research for a cure for MS??!!

I have another theory that you applied for a job at Biogen, got rejected, and never forgave them! :lol:


If Biogen ever decided to hire me, it would be for target practice on their gun range :)

Harry
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Postby bromley » Sat Jun 10, 2006 9:04 am

Harry,

You've got too much time on your hands - worrying about Biogen and Tysabri (I'll send you a vial to try when my order comes through).

Have you considered cognitive therapy? Your obsession with Biogen and Tysabri is bordering the compulsive obsessive. I've spoken to a shrink and he says that to kick off your therapy - you should stop posting about Biogen or Tysabri for three months. See if you can do it - he says you'll feel much better.

If you cannot help but keep posting then his advice is for you to get a job to keep your mind off it. He thinks a job where you have to make something is good and you're intelligent, so maybe a position as a supervisor. You know I only have your best interests at heart Harry. :D

http://www.biogen.com/manufacturing/


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Postby HarryZ » Sat Jun 10, 2006 10:18 am

Ian,

You've got too much time on your hands - worrying about Biogen and Tysabri (I'll send you a vial to try when my order comes through).


Ah heck, Ian, I don't worry about Biogen/Elan and Tysabri....I just find their every move so predictable in the world of big pharma. I only spend a few minutes a day following their actions. And hey, don't send me a vial of the stuff....could never afford what they are asking for it :)

Have you considered cognitive therapy?


My cognitive abilities are just fine, thank you.

Your obsession with Biogen and Tysabri is bordering the complusive obsessive. I've spoken to a shrink and he says that to kick off your therapy - you should stop posting about Biogen or Tysabri for three months. See if you can d0 it - he says you'll feel much better.


Somebody has to keep a balanced perspective going about this company and drug....might as well be me. But I'll tell you what.....I'll consider to stop posting if you'll do the same...and I think you post far more messages on this forum than I do!

If you cannot help but keep posting then his advice is for you to get a job to keep your mind off it. He thinkg a job where you have to make soemthing is good and you're intelligent, so may be a position as a supervisor. You know I only have your best interests at heart Harry. :D


Geez Ian, if you have my best interests at heart with that advice, I'd hate to think what it would be like if you weren't looking after my interests :D I guess I should have followed your advice months ago and purchased all kinds of shares in Biogen....with what they are going to charge for Tysabri, I 'd be able to retire within a few months :)

Harry
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Postby bromley » Sat Jun 10, 2006 11:54 am

Harry,

I will stop posting


The shrink thinks this is wonderful news - it's a sign that you know you have a problem and you're willing to take action to address it.

Arron and I think it best if you have a six month break from posting. Enjoy the break and the wonderful Canadian summer. Look forward to hearing from you at Christmas.

Best wishes from all of us at thisisms.

Ian :twisted:

PS Good luck with that job application
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Postby HarryZ » Sat Jun 10, 2006 4:22 pm

Ian,

I will stop posting


I've finally got this all figured out....you must work for the transcript department of trial data for Elan. I said in my previous message that "I will consider to stop posting" and you quoted the above. I'm thinking that this is the same thing that Elan does to make their trial data sound so good :D

The shrink thinks this is wonderful news - it's a sign that you know you have a problem and you're willing to take action to address it.


Sounds like the shrink works for Elan and is extremely happy at the prospect that you told him that I won't be posting for a while. I hope you break the news gently to him that this is only a consideration!

Arron and I think it best if you have a six month break from posting. Enjoy the break and the wonderful Canadian summer. Look forward to hearing from you at Christmas.


How did Arron get involved with this?....he's one of my friends and would never condone me taking a sabbatical from the forum...the readership might drop off. :wink:

PS Good luck with that job application


They told me in the interview that I would have to sell Tysabri to anyone who wanted it. I suddenly went into deep shock and stopped breathing for a few seconds. The interviewer told me that this happened to some patients in the trials but not to worry....they had a transcriber in England who wrote up the trial data and he would make it look like a sneezing episode gone bad. :wink:

Take care.

Harry
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Postby bromley » Sun Jun 11, 2006 3:29 am

Harry,

I don't worry about Biogen/Elan and Tysabri.. I only spend a few minutes a day following their actions.


A few minutes a day - even Biogen couldn't come up with misleading figures like this.

Harry we are all worried for you. As your only true friend on the site - can I suggest that you get your deckchair out and relax. A Budhist friend suggests that each morning you get up and repeat the following "Tysabri is good, Biogen are good". 20 times each morning should be sufficient.

I have spoke to Arron and we have decided not to ban you from the site. We would welome your postings, on the condition that they are not about Biogen or Tysabri. Welcome back to the fold, I really hope you can comply with this condition - I would hate to see you ejected from this site.

All the best

Ian :lol:
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