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Tysabri making headlines on Friday ....
This report is from the NASDAQ ******* business site - tracking key issues on the stock market - Biogen's stock fell Friday on heavy trading with the release of this news about their star drug ......
it is astonishing to think they make $1 BILLION dollars a year on this drug. - Lulu
4th UPDATE: EU Reviewing Biogen, Elan's Tysabri; Cites PML
(Updates with FDA comments, beginning in the third paragraph.)
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- A European panel has started a review of the controversial Multiple Sclerosis drug Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. PLC (ELN), citing a much higher number of rare brain infections than previously disclosed.
The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a key product for Biogen and Elan that generates nearly $1 billion in yearly revenue. Both stocks fell on heavy volume Friday.
The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported 23 cases of progressive multifocal leukoencephalopathy, or PML, a number that the Food and Drug Administration later confirmed, adding that those cases were after Tysabri returned to the market in 2006. The FDA said it is continuing to assess the situation.
A Biogen spokeswoman, citing company policy, declined to comment on the number of PML cases. The company last reported 11 cases in July, when the company stopped providing weekly Tysabri update, and two more have been confirmed since then. The number of PML cases among Tysabri users is closely watched because the drug's label suggests an infection risk to one in every 1,000 patients.
Tysabri was removed for 18 months beginning in 2005 because of a link to three other PML cases but was allowed back on the market after patients and physicians pushed for its return. The drug, despite the PML risk, is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options.
The European panel said Friday that its review will discuss "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."
Christopher Raymond, an analyst with Robert Baird, said European regulators are unlikely to remove it from the market, but they may recommend that long-term patients take a break from using the drug to help balance risk. Duration of use is seen as raising the risk factor for PML.
Earlier this week, Biogen acknowledged that it is talks with the FDA to amend Tysabri's label to reflect increased PML risk with longer-term usage. Changing the label marks a shift for Biogen, which has long maintained there was no clear connection to duration and increased risk of PML, but mounting evidence has made that link clear.
The increased potential of patients taking a break, or "drug holiday," from Tysabri could affect its sales growth, and that prospect weighed on shares of Biogen and Elan on Friday. Shares of Cambridge, Mass.-based Biogen recently fell 5.8% to $44.49, while the American depository receipts of Dublin-based Elan plunged 20% to $5.17.
Biogen spokeswoman Naomi Aoki said the incidents of PML remain rare, reiterating the company's contention that the rate remains within the 1-in-1,000 patient level implied by its label.
As of Sept. 30, about 46,200 people worldwide were taking Tysabri with about 13,400 patients on the drug for more than 24 months. Because duration is seen as an issue, there is a debate as to which number to compare to the number of PML cases--either the total number of patients or just those on Tysabri for two or more years.
Aoki stressed the strong effectiveness of the drug in treating the debilitating disease and said the risk/benefit profile remains favorable.
"We don't think it is beneficial to comment on the numbers because it is within the [label's] rate," she said.
Officials from Elan weren't immediately available to comment.
Sanford Bernstein analyst Geoffrey Porges said the significance of the cases is hard to gauge without further details, but estimated that Biogen's stock would be worth $41 without Tysabri.
"These new cases are likely to alarm physicians whose comfort with the product had been increasing in recent months, and should catalyze academic and regulatory discussions about more active risk mitigation strategies," he wrote in a note to clients.
The new cases also might reignite a debate over disclosure of new PML cases. Neither company regularly provides such updates, which has caused some frustration on Wall Street.
Biogen - which was giving weekly updates until July 24, the third anniversary of Tysabri's relaunch - argues that disclosing such information isn't helpful, because the PML rate is already on the label and FDA is aware of all new cases. Thus, the new information only creates fear among patients and physicians.
Furthermore, Biogen has said, such negative information can be used by other drug makers in the increasingly competitive MS treatment market.
it is astonishing to think they make $1 BILLION dollars a year on this drug. - Lulu
4th UPDATE: EU Reviewing Biogen, Elan's Tysabri; Cites PML
(Updates with FDA comments, beginning in the third paragraph.)
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- A European panel has started a review of the controversial Multiple Sclerosis drug Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. PLC (ELN), citing a much higher number of rare brain infections than previously disclosed.
The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a key product for Biogen and Elan that generates nearly $1 billion in yearly revenue. Both stocks fell on heavy volume Friday.
The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported 23 cases of progressive multifocal leukoencephalopathy, or PML, a number that the Food and Drug Administration later confirmed, adding that those cases were after Tysabri returned to the market in 2006. The FDA said it is continuing to assess the situation.
A Biogen spokeswoman, citing company policy, declined to comment on the number of PML cases. The company last reported 11 cases in July, when the company stopped providing weekly Tysabri update, and two more have been confirmed since then. The number of PML cases among Tysabri users is closely watched because the drug's label suggests an infection risk to one in every 1,000 patients.
Tysabri was removed for 18 months beginning in 2005 because of a link to three other PML cases but was allowed back on the market after patients and physicians pushed for its return. The drug, despite the PML risk, is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options.
The European panel said Friday that its review will discuss "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."
Christopher Raymond, an analyst with Robert Baird, said European regulators are unlikely to remove it from the market, but they may recommend that long-term patients take a break from using the drug to help balance risk. Duration of use is seen as raising the risk factor for PML.
Earlier this week, Biogen acknowledged that it is talks with the FDA to amend Tysabri's label to reflect increased PML risk with longer-term usage. Changing the label marks a shift for Biogen, which has long maintained there was no clear connection to duration and increased risk of PML, but mounting evidence has made that link clear.
The increased potential of patients taking a break, or "drug holiday," from Tysabri could affect its sales growth, and that prospect weighed on shares of Biogen and Elan on Friday. Shares of Cambridge, Mass.-based Biogen recently fell 5.8% to $44.49, while the American depository receipts of Dublin-based Elan plunged 20% to $5.17.
Biogen spokeswoman Naomi Aoki said the incidents of PML remain rare, reiterating the company's contention that the rate remains within the 1-in-1,000 patient level implied by its label.
As of Sept. 30, about 46,200 people worldwide were taking Tysabri with about 13,400 patients on the drug for more than 24 months. Because duration is seen as an issue, there is a debate as to which number to compare to the number of PML cases--either the total number of patients or just those on Tysabri for two or more years.
Aoki stressed the strong effectiveness of the drug in treating the debilitating disease and said the risk/benefit profile remains favorable.
"We don't think it is beneficial to comment on the numbers because it is within the [label's] rate," she said.
Officials from Elan weren't immediately available to comment.
Sanford Bernstein analyst Geoffrey Porges said the significance of the cases is hard to gauge without further details, but estimated that Biogen's stock would be worth $41 without Tysabri.
"These new cases are likely to alarm physicians whose comfort with the product had been increasing in recent months, and should catalyze academic and regulatory discussions about more active risk mitigation strategies," he wrote in a note to clients.
The new cases also might reignite a debate over disclosure of new PML cases. Neither company regularly provides such updates, which has caused some frustration on Wall Street.
Biogen - which was giving weekly updates until July 24, the third anniversary of Tysabri's relaunch - argues that disclosing such information isn't helpful, because the PML rate is already on the label and FDA is aware of all new cases. Thus, the new information only creates fear among patients and physicians.
Furthermore, Biogen has said, such negative information can be used by other drug makers in the increasingly competitive MS treatment market.
The MS Specialist who spoke last week end hinted Tysabri will probably be pulled in America soon. Legally I do not think he could say what he was thinking.
He said he was disturbed by the recent statistics. He was not speaking to the News but his own statistics he uses for his power points. He said it is a great treatment if it did not have the risk.
The whole pharmaceutical thing is a puzzle. Who of us would not want a treatment that could help sooner than later. Like who would not want an oral DMD now or something that worked better than steroids?
At the same time we do not want to be on a medication that causes great harm in the long run.
I for one will be an educated consumer but will not give up on pharmaceuticals. I am on many which can be dangerous but I monitor them. Some actually keep me alive and others have kept me from frequent Doctors visits. They also keep me completely out of ERs and hospitals.
I am glad I live in this age of medicine. The last person in an iron lung from Polio died recently.
Alex
He said he was disturbed by the recent statistics. He was not speaking to the News but his own statistics he uses for his power points. He said it is a great treatment if it did not have the risk.
The whole pharmaceutical thing is a puzzle. Who of us would not want a treatment that could help sooner than later. Like who would not want an oral DMD now or something that worked better than steroids?
At the same time we do not want to be on a medication that causes great harm in the long run.
I for one will be an educated consumer but will not give up on pharmaceuticals. I am on many which can be dangerous but I monitor them. Some actually keep me alive and others have kept me from frequent Doctors visits. They also keep me completely out of ERs and hospitals.
I am glad I live in this age of medicine. The last person in an iron lung from Polio died recently.
Alex
Sweetie, I am so glad you shared this news with the group. We have to become our own (watch dogs), if the Doctors can't even be open and honest with us...
Right now I am on a very strong drug for nerve pain, and I have to hope the web sites and my Doctor are being totally honest with me... This is rather scary..
I see Dr. Patel this after noon and I know he is the most open & HONEST Doctor I have and I am going to ask him what he thinks a Cymbalta, it is helping with the nerve pain, but I am hoping it isn't doing too much damage...
So Thanks again Lulu and Debi for this important information...
Every one take good care of yourselves, remember second & Third opinions are a GOOD THING
Have a love filled day {{{{~!~}}}} DJ
Right now I am on a very strong drug for nerve pain, and I have to hope the web sites and my Doctor are being totally honest with me... This is rather scary..
I see Dr. Patel this after noon and I know he is the most open & HONEST Doctor I have and I am going to ask him what he thinks a Cymbalta, it is helping with the nerve pain, but I am hoping it isn't doing too much damage...
So Thanks again Lulu and Debi for this important information...
Every one take good care of yourselves, remember second & Third opinions are a GOOD THING
Have a love filled day {{{{~!~}}}} DJ
Very important news about Tysabri. I have to share this news now, even though I am so tired after my second opinion today with a Neuro. Tysabri WILL be withdrawn from the EU market within the next 6 months.
Neuro told me that more people have PML than we know, but he would not give me the figures. It was released to Neuros and Dr's alike on Monday - they were told not to give information out to patients!!!!!! People like me who asked!!! No comment was the answer, but a lot more than is being said by Biogen.
Incredible.
Debs xxxxx
Neuro told me that more people have PML than we know, but he would not give me the figures. It was released to Neuros and Dr's alike on Monday - they were told not to give information out to patients!!!!!! People like me who asked!!! No comment was the answer, but a lot more than is being said by Biogen.
Incredible.
Debs xxxxx
From what I have seen this is just business as usual. Withholding important information about risk from patients has become par for the course - this is NOT unusual! For instance, how many women who are encouraged to have amniocentesis are ever told about the risk of losing their pregnancy from that procedure? Yet from what I read, about 1 out of 100 will.
Remember, big Pharma could never make its huge profits without the cooperation of all the doctors busy writing prescriptions . . . which are often used like bandaids to cover up patient symptoms rather than seek out their etiologies.
Haven't you seen the pharmaceutical representatives the companies send in to the doctors - often very attractive women in high heels, dressed to the 9's, with low-cut necklines etc. Also, big Pharma may buy lunch for the entire office as well as give substantial gifts, such as cars or vacations to the MDs. This all should be illegal (but would likely be hard to enforce).
I'm starting to lean more toward homeopathics which work with your body instead of against it like so many of our FDA-approved medications.
I'm interested in getting a diagnosis not so I can start on medication, but because I want to face my attacker.
WAF
Remember, big Pharma could never make its huge profits without the cooperation of all the doctors busy writing prescriptions . . . which are often used like bandaids to cover up patient symptoms rather than seek out their etiologies.
Haven't you seen the pharmaceutical representatives the companies send in to the doctors - often very attractive women in high heels, dressed to the 9's, with low-cut necklines etc. Also, big Pharma may buy lunch for the entire office as well as give substantial gifts, such as cars or vacations to the MDs. This all should be illegal (but would likely be hard to enforce).
I'm starting to lean more toward homeopathics which work with your body instead of against it like so many of our FDA-approved medications.
I'm interested in getting a diagnosis not so I can start on medication, but because I want to face my attacker.
WAF
Wow!! We use to have rights like at least know what the side effects are of meds.. if they dont tell about this - lots of newbies could take it... not knowing- this isnt right!! tick
Debi, if you still had any doubts about your decision not to take this drug at this time, I hope this will confirm for you that your decision was the right one for you.. With all the other issues you are confronting right now I have Not One Bit Of Problem with supporting your decision. Of Course I would Always Support You and any decision you might make regarding your health care. We each have to make up our own minds about which treatments we will use. No One not even our Doctors should ever withdraw their support, because some one disagrees with them. That crazy Doctor was so wrong in so many areas, he blew my mind, what little bit I have left at this point...LOL ;-)
Love and Gentle Hugs {{{{~!~}}}} DJ
Love and Gentle Hugs {{{{~!~}}}} DJ
It's making big healines here in EU. I tried posting before, but I think I put too many weblinks in oops!!
Anyway I will try it this way. Reuters. Go there and they have even more information.
It's correct, Biogen are NOT giving out any more reports on patients contracting PML. This is not fair. We as patients have a right to know what the implicatiion of taking ANY form of drug are!!
Biogen are just looking at their bottom line - but at what expense to their patients??
Neuro's in EU are watching very carefully at the reports, confidence had been growing in this drug, and more Neuro's were willing giving the drug out - now they are waiting for Biogen to disclose full results.
Hope this gets posted :)
Debs xxxx
Anyway I will try it this way. Reuters. Go there and they have even more information.
It's correct, Biogen are NOT giving out any more reports on patients contracting PML. This is not fair. We as patients have a right to know what the implicatiion of taking ANY form of drug are!!
Biogen are just looking at their bottom line - but at what expense to their patients??
Neuro's in EU are watching very carefully at the reports, confidence had been growing in this drug, and more Neuro's were willing giving the drug out - now they are waiting for Biogen to disclose full results.
Hope this gets posted :)
Debs xxxx
The number of PML cases is now up to 24.
Even Biogen will admit that the rate is about 1:1000, and the odds go up the longer you've been on the drug. This is a small percentage, but I don't think that's too encouraging given that PML is often fatal, and if you don't die, you have a good chance of being left with brain damage.
What I find really disturbing is Biogen's decision not to report PML cases anymore, since every time they announced a new case their stock price took a hit.
Even Biogen will admit that the rate is about 1:1000, and the odds go up the longer you've been on the drug. This is a small percentage, but I don't think that's too encouraging given that PML is often fatal, and if you don't die, you have a good chance of being left with brain damage.
What I find really disturbing is Biogen's decision not to report PML cases anymore, since every time they announced a new case their stock price took a hit.
I am Shocked that more of our group hasn't responded to this Posting. I found this information to be an eye opener and we need to follow this story closely, this isn't off the table as a life altering drug for those with aggressive MS, am I right?
I am wondering what other drugs are being offer with out a full disclosure of the more dangerous side effects..and are we being offered the correct data?..
Lulu Thank you so much for checking this out... Looking forward to more up dates..
Quix I think your question about how much of the profits are these drug companies are reinvesting into their Research and Development and how much is going into the pockets of CEOs and investors is also very interesting...
We better start caring and looking out for ourselves, because no one else seems to be watching out for us.... Shame on them !!!!!
{{{{{{{~!~}}}}}}}} DJ
I am wondering what other drugs are being offer with out a full disclosure of the more dangerous side effects..and are we being offered the correct data?..
Lulu Thank you so much for checking this out... Looking forward to more up dates..
Quix I think your question about how much of the profits are these drug companies are reinvesting into their Research and Development and how much is going into the pockets of CEOs and investors is also very interesting...
We better start caring and looking out for ourselves, because no one else seems to be watching out for us.... Shame on them !!!!!
{{{{{{{~!~}}}}}}}} DJ
Teva is the name behind so many of our drugs here in the US - if I'm remembering correctly they have amassed a large share of the market in generic drugs in addition to their name brand drugs like Copaxone.
BigPharma is an amzing money making machine!
Lulu
BigPharma is an amzing money making machine!
Lulu
I want to see how much is being re-invested in R & D versus how much is going to shareholders. A lot of people are getting rich on my misery.
Q
Q
What strikes me at the core of this story is the intentional omission of details to patients who are truly concerned about these risks. Don't they deserve to know all of the facts and then make their choices accordingly?
I would guess that this is just the beginning of reevaluating Tysabri and its use. These initial questions are coming from from the EU.
The revenue from this drug is obscene - I would really like to see the breakdown of which country supplies which percentage of this income. I would bet like most other licensed drugs that the US users contributes the most. That this story is news for the NASDAQ is significant and the article gives a different perspective for us - see the drugs for what they are - not looking at the medical use, but evaluating them as money makers for investors.
But then that is pretty much the same for all drugs here ... and the argument is that big pharma has invested in the R&D for a drug and deserves to be rewarded for their work.
Lu
I want to caution all here about doing their own calculations from these numbers.
And I don't want to be seen as a Biogen apologist.
There are two many variables to draw conclusions from this data. They state that there have been 23 cases of PML since Tysabri was returned to the market three years ago. They also say that only 13,600 have been on the drug for more than 24 months. This looks like closer to 1 in 500 risk of PML, but THAT CAN NOT BE INFERRED here. PML has been seen to occur between 15 and 35 months. To understand the real risk we need to know how long each of the cases had been on the drug. If any had been on the drug for fewer than 24 months, then the number of people on the drug will rise greatly and the risk will drop.
That's why we can't take a few numbers and run with them.
On another note, I, too, am angered at the 1 BILLION yearly revenues. How can a company collect such vast profits from a drug, yet keep it's cost so high that some people cannot afford it? Avonex it's flagship drug raked in $2.2 billion in 2008 - a number that was increasing rapidly quarter to quarter. Why, then can they justify ANYONE not being able to afford it? I did not have the discretionary money to apy to get myself into and out of the Medicare donut hole ($4300) over the two months that I need to afford the Avonex. I have to do this every year. My income is good, but it is stretched by paying for my sister and my parents. I could only afford the Avonex by putting the $4300 on credit cards every year.
Now I am facing the same thing with Copaxone. I make too much to qualify for any assistance, unless I want to add a few thousand dollars to my credit cards each year.
I thank Lulu for this article, but caution anyone against making firm conclusions. This business article does not give enough info to understand the real risk. And I remain P!ssed off at Big Pharma and its greed.
Q :((
And I don't want to be seen as a Biogen apologist.
There are two many variables to draw conclusions from this data. They state that there have been 23 cases of PML since Tysabri was returned to the market three years ago. They also say that only 13,600 have been on the drug for more than 24 months. This looks like closer to 1 in 500 risk of PML, but THAT CAN NOT BE INFERRED here. PML has been seen to occur between 15 and 35 months. To understand the real risk we need to know how long each of the cases had been on the drug. If any had been on the drug for fewer than 24 months, then the number of people on the drug will rise greatly and the risk will drop.
That's why we can't take a few numbers and run with them.
On another note, I, too, am angered at the 1 BILLION yearly revenues. How can a company collect such vast profits from a drug, yet keep it's cost so high that some people cannot afford it? Avonex it's flagship drug raked in $2.2 billion in 2008 - a number that was increasing rapidly quarter to quarter. Why, then can they justify ANYONE not being able to afford it? I did not have the discretionary money to apy to get myself into and out of the Medicare donut hole ($4300) over the two months that I need to afford the Avonex. I have to do this every year. My income is good, but it is stretched by paying for my sister and my parents. I could only afford the Avonex by putting the $4300 on credit cards every year.
Now I am facing the same thing with Copaxone. I make too much to qualify for any assistance, unless I want to add a few thousand dollars to my credit cards each year.
I thank Lulu for this article, but caution anyone against making firm conclusions. This business article does not give enough info to understand the real risk. And I remain P!ssed off at Big Pharma and its greed.
Q :((
I hope Debi catches this post it is so important. See this is what I have been saying about you, No matter what is going on in your life you always find time to check for important stuff our group needs to know about.. You are One Amazing Lady and I am so Blessed to call you my Dear Friend...
Much love, Gentle Hugs and Many Prayers.. {{{{{{{~!~}}}}}}} DJ
Much love, Gentle Hugs and Many Prayers.. {{{{{{{~!~}}}}}}} DJ
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