Was there an MS related topic prior to Tysabri that generated this much controversy? I think alot of the traffic on these boards will dry up once the drug is re-released.
What are we going to do for entertainment once the Tysabri debate is resolved? We'll have to start creating "OT" threads on topics like "What should I name my cat?"
Meanwhile I'm enjoying the heck out of all of the banter. The recent B.T. thread that roasted Harry was a classic.!
Oh BTW, what is a "nick" Finn? Is that the same as a "yahoo"?
Tysabri info
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HarryZ
- Family Elder
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- Contact:
Denver,
Harry
LDN a couple of years ago generated a ton of traffic and there will be other topics that will come along and do the same.DenverCO wrote:Was there an MS related topic prior to Tysabri that generated this much controversy? I think alot of the traffic on these boards will dry up once the drug is re-released.
It will likely be some time before the Tysabri debate ceases for good.What are we going to do for entertainment once the Tysabri debate is resolved? We'll have to start creating "OT" threads on topics like "What should I name my cat?"
Hmmm, some of the readers over there might not like you stating that thread was "enjoyment". And some of the readers there certainly don't like me!Meanwhile I'm enjoying the heck out of all of the banter. The recent B.T. thread that roasted Harry was a classic.!
Harry
Sorry, time to leave the board.
-finn
-finn
Last edited by finn on Sun Aug 28, 2005 1:32 pm, edited 1 time in total.
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better2gether
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Elan boss confident MS drug will return to market
.
Elan boss confident MS drug will return to market
Thu May 26, 2005 09:23 AM ET
DUBLIN, May 26 (Reuters) - Elan Corp Chief Executive Kelly Martin repeated on Thursday he was confident the company's suspended multiple sclerosis (MS) drug Tysabri would return to market and that demand would be strong.
Speaking to reporters following Elan's annual shareholder meeting in Dublin, Martin said: "It's our view that if you look at the number of patients who need therapy and at how effective Tysabri is, it will find its way back to the market."
Martin's comments echoed those made in an interview with Reuters following full-year results last month.
Elan, which has clawed its way back from near-collapse three years ago, had been pinning its future on Tysabri -- formerly known as Antegren -- but was forced to withdraw it in February after the death of a patient.
Shares in Elan, whose stock has plunged by 70 percent since the suspension, were up 12 percent at 6.24 euros in Dublin by 1230 GMT on what dealers said was short cover buying by U.S. traders following the shareholder meeting.
Trade in the stock, which has been volatile in recent months given the uncertainty over Tysabri's future, was relatively thin on Thursday.
On whether Tysabri's potential in the market had been affected by the suspension, Martin said there were still the same number of patients who still had the same issues.
"I think the demand side of the curve is a given. What I can't predict, with the risk benefit discretions and based on individual patients or doctors, is what the uptake will be versus what it was," he said.
"(But) there's no reason over time why Tysabri would not be a very substantial drug in MS."
Martin said the safety probe into Tysabri was on schedule to conclude by mid-to-late summer and then discussions with the U.S. Food and Drug Administration (FDA) could begin.
While it was premature to estimate how long the talks would go on, the Elan chief said he thought they would move quickly.
If the FDA gave the go-ahead Tysabri could be back on the market "the next day", he added.
Asked how much Tysabri's suspension was costing the company, Martin said the total budget for the drug, shared between Elan and U.S. partner Biogen Idec , was between $300 million and $350 million and that, since Tysabri was generating no revenue, this was the extent of the financial hit.
<shortened url>
.
Elan boss confident MS drug will return to market
Thu May 26, 2005 09:23 AM ET
DUBLIN, May 26 (Reuters) - Elan Corp Chief Executive Kelly Martin repeated on Thursday he was confident the company's suspended multiple sclerosis (MS) drug Tysabri would return to market and that demand would be strong.
Speaking to reporters following Elan's annual shareholder meeting in Dublin, Martin said: "It's our view that if you look at the number of patients who need therapy and at how effective Tysabri is, it will find its way back to the market."
Martin's comments echoed those made in an interview with Reuters following full-year results last month.
Elan, which has clawed its way back from near-collapse three years ago, had been pinning its future on Tysabri -- formerly known as Antegren -- but was forced to withdraw it in February after the death of a patient.
Shares in Elan, whose stock has plunged by 70 percent since the suspension, were up 12 percent at 6.24 euros in Dublin by 1230 GMT on what dealers said was short cover buying by U.S. traders following the shareholder meeting.
Trade in the stock, which has been volatile in recent months given the uncertainty over Tysabri's future, was relatively thin on Thursday.
On whether Tysabri's potential in the market had been affected by the suspension, Martin said there were still the same number of patients who still had the same issues.
"I think the demand side of the curve is a given. What I can't predict, with the risk benefit discretions and based on individual patients or doctors, is what the uptake will be versus what it was," he said.
"(But) there's no reason over time why Tysabri would not be a very substantial drug in MS."
Martin said the safety probe into Tysabri was on schedule to conclude by mid-to-late summer and then discussions with the U.S. Food and Drug Administration (FDA) could begin.
While it was premature to estimate how long the talks would go on, the Elan chief said he thought they would move quickly.
If the FDA gave the go-ahead Tysabri could be back on the market "the next day", he added.
Asked how much Tysabri's suspension was costing the company, Martin said the total budget for the drug, shared between Elan and U.S. partner Biogen Idec , was between $300 million and $350 million and that, since Tysabri was generating no revenue, this was the extent of the financial hit.
<shortened url>
.
Sorry, time to leave the board.
-finn
-finn
Last edited by finn on Sun Aug 28, 2005 1:33 pm, edited 1 time in total.
Meanwhile I'm enjoying the heck out of all of the banter. The recent B.T. thread that roasted Harry was a classic.!
Harry,Hmmm, some of the readers over there might not like you stating that thread was "enjoyment". And some of the readers there certainly don't like me!
Harry
Perhaps "enjoyment" was the wrong word to use, but there was clearly an element of "compelling drama" to that thread, thus the large number of hits.
I would like to add that even though you and I disagree on many MS related issues, you are always a complete gentlemen in heated discussions, and for that you have my utmost respect.
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HarryZ
- Family Elder
- Posts: 2572
- Joined: Tue May 25, 2004 2:00 pm
- Location: London, ON, Canada
- Contact:
Denver,
Take care.
Harry
I wonder if that makes the thread eligible for a documentary academy award nomination next year?Perhaps "enjoyment" was the wrong word to use, but there was clearly an element of "compelling drama" to that thread, thus the large number of hits.
I thank you a lot for that comment... it is very appreciated. I do admit that sometimes I have to bight my tongue during some threads but becoming personal and aggressive serves no purpose during a debate.I would like to add that even though you and I disagree on many MS related issues, you are always a complete gentlemen in heated discussions, and for that you have my utmost respect.
Take care.
Harry
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better2gether
- Family Elder
- Posts: 188
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NCB - remains positive
.
NCB - remains positive
AGM focuses on strategy for Tysabri's return
Our analysis: Elan continues to be confident about Tysabri's return. The review of the data from the 3,000 patients in the Tysabri clinical trials continues on track with a completion date of late Q2, 2005 at which point the data will be analyzed and subsequently discussed with the FDA.
An FDA advisory panel, whose primary focus will be on the safety of the drug given that Tysabri’s efficacy is well established, will likely assess the data generated from the review. We would anticipate an advisory meeting occurring in early Q4. As previously highlighted it is impossible to predict the outcome of the review and any advisory panel discussions, as further cases of PML may be uncovered although we would expect any additional cases of PML in patients on monotherapy to be disclosed.
Alongside the review, the company is working through a risk management program with little details disclosed. The focus is on:
(i) identifying at risk individuals
(ii) monitoring of patients once treatment begins
(iii) the treatment strategy should patients develop PML.
Possible risk management strategies that we believe that the FDA may require for a return of Tysabri to the market include
(i) assaying for lymphocyte counts prior to treatment (low lymphocyte counts are suggestive of an immunocompromised condition)
(ii) screening the cerebrospinal fluid prior to treatment or should suspicions of PML exist during treatment (this could confirm if the JC virus is present in the CSF)
(iii) periodically assaying for the saturation of the alpha-4 receptor during Tysabri treatment (high saturation of the alpha-4 integrin receptor is likely to be a risk factor in PML) and/or
(iv) MRIs prior to and at routine intervals during treatment for monitoring purposes. Should patients develop PML, a recent study provides some evidence that early detection of drug-induced PML (as opposed to AIDS -induced PML) in a transplant patient followed by withdrawal of immunosuppressive therapy significantly improved the survival rate.
Despite the benefits of the drug and the existing unmet medical need in MS, the main risk is that the FDA may be unable to adequately quantify the risk of developing PML with Tysabri and/or may conclude that the risk does not offset the benefits of the drug. Further studies may be required although it is our view that post-marketing studies are the best way to accurately establish the true incidence rates (there is over 4,000 patient years of monotherapy and to our knowledge one case of PML (albeit in a very immunosuppressed patient) and should Tysabri return it is likely that the first 10,000-20,000 patients would be closely monitored.
Management believe that significant demand from MS patients who feel that their quality of life is adversely affected by the withdrawal of the product should support a return to the market and the FDA will seek patient input in considering the re-commercialization of Tysabri. If Tysabri does return to the market, we believe that strong patient demand will exist. More caution is likely to be displayed by the neurologists post commercialization.
At this stage it is worth considering Tysabri's potential in MS (relapsing-remitting) should it return to the market. We estimate in the US that over 50,000 MS patients have fallen off-treatment and c.65% of the 200,000 treated patients will suffer breakthrough disease (relapses) over the coming years. Thus up to 180,000 MS suffers in the US would likely benefit from a more effective therapy over the near to mid-term. If, for example, Tysabri achieved 20% market penetration in this “second-line” segment in the US, MS sales of c.$850m could be achieved.
Upcoming newsflow includes the release of Phase III induction data in late June for Tysabri in Crohn's disease. The previous induction trial failed to meet the primary endpoint (at week 10) although it achieved with significance the targeted induction level at week 12. We expect the data from this repeat trial to clarify the role that Tysabri could have in treating Crohn's disease. In addition, the results of the six-month Phase II rheumatoid arthritis trial are expected in Q3. We are less optimistic about the prospects of Tysabri in RA given that patients are typically treated concomitantly with immunosuppressive therapy.
Our conclusion:
It is our view that the third PML case was complex and atypical of patients participating in the monotherapy trial with the patient immunocompromised prior to Tysabri treatment. With no news of additional cases in the monotherapy group and an improved understanding of PML, the path back to the market for Tysabri looks clearer. At the current valuation we estimate that a value of Tysabri of c.$900m is implied (based on the top end of our sum-of-the-parts analysis) in the current share price. Re-commercialization in the US and in Europe in our view can over time support a revenue potential of >$1bn for Tysabri in MS.
On balance we remain positive on the re-commercialization of Tysabri in MS.
.
NCB - remains positive
AGM focuses on strategy for Tysabri's return
Our analysis: Elan continues to be confident about Tysabri's return. The review of the data from the 3,000 patients in the Tysabri clinical trials continues on track with a completion date of late Q2, 2005 at which point the data will be analyzed and subsequently discussed with the FDA.
An FDA advisory panel, whose primary focus will be on the safety of the drug given that Tysabri’s efficacy is well established, will likely assess the data generated from the review. We would anticipate an advisory meeting occurring in early Q4. As previously highlighted it is impossible to predict the outcome of the review and any advisory panel discussions, as further cases of PML may be uncovered although we would expect any additional cases of PML in patients on monotherapy to be disclosed.
Alongside the review, the company is working through a risk management program with little details disclosed. The focus is on:
(i) identifying at risk individuals
(ii) monitoring of patients once treatment begins
(iii) the treatment strategy should patients develop PML.
Possible risk management strategies that we believe that the FDA may require for a return of Tysabri to the market include
(i) assaying for lymphocyte counts prior to treatment (low lymphocyte counts are suggestive of an immunocompromised condition)
(ii) screening the cerebrospinal fluid prior to treatment or should suspicions of PML exist during treatment (this could confirm if the JC virus is present in the CSF)
(iii) periodically assaying for the saturation of the alpha-4 receptor during Tysabri treatment (high saturation of the alpha-4 integrin receptor is likely to be a risk factor in PML) and/or
(iv) MRIs prior to and at routine intervals during treatment for monitoring purposes. Should patients develop PML, a recent study provides some evidence that early detection of drug-induced PML (as opposed to AIDS -induced PML) in a transplant patient followed by withdrawal of immunosuppressive therapy significantly improved the survival rate.
Despite the benefits of the drug and the existing unmet medical need in MS, the main risk is that the FDA may be unable to adequately quantify the risk of developing PML with Tysabri and/or may conclude that the risk does not offset the benefits of the drug. Further studies may be required although it is our view that post-marketing studies are the best way to accurately establish the true incidence rates (there is over 4,000 patient years of monotherapy and to our knowledge one case of PML (albeit in a very immunosuppressed patient) and should Tysabri return it is likely that the first 10,000-20,000 patients would be closely monitored.
Management believe that significant demand from MS patients who feel that their quality of life is adversely affected by the withdrawal of the product should support a return to the market and the FDA will seek patient input in considering the re-commercialization of Tysabri. If Tysabri does return to the market, we believe that strong patient demand will exist. More caution is likely to be displayed by the neurologists post commercialization.
At this stage it is worth considering Tysabri's potential in MS (relapsing-remitting) should it return to the market. We estimate in the US that over 50,000 MS patients have fallen off-treatment and c.65% of the 200,000 treated patients will suffer breakthrough disease (relapses) over the coming years. Thus up to 180,000 MS suffers in the US would likely benefit from a more effective therapy over the near to mid-term. If, for example, Tysabri achieved 20% market penetration in this “second-line” segment in the US, MS sales of c.$850m could be achieved.
Upcoming newsflow includes the release of Phase III induction data in late June for Tysabri in Crohn's disease. The previous induction trial failed to meet the primary endpoint (at week 10) although it achieved with significance the targeted induction level at week 12. We expect the data from this repeat trial to clarify the role that Tysabri could have in treating Crohn's disease. In addition, the results of the six-month Phase II rheumatoid arthritis trial are expected in Q3. We are less optimistic about the prospects of Tysabri in RA given that patients are typically treated concomitantly with immunosuppressive therapy.
Our conclusion:
It is our view that the third PML case was complex and atypical of patients participating in the monotherapy trial with the patient immunocompromised prior to Tysabri treatment. With no news of additional cases in the monotherapy group and an improved understanding of PML, the path back to the market for Tysabri looks clearer. At the current valuation we estimate that a value of Tysabri of c.$900m is implied (based on the top end of our sum-of-the-parts analysis) in the current share price. Re-commercialization in the US and in Europe in our view can over time support a revenue potential of >$1bn for Tysabri in MS.
On balance we remain positive on the re-commercialization of Tysabri in MS.
.
-
better2gether
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FDA will be under pressure to resume sale of MS drug Tysabri
.
Sunday Business Post
FDA will be under pressure to resume sale of MS drug Tysabri
29 May 2005
The way Elan tells it, by the end of this summer the safety panel of the US Food and Drug Administration (FDA) will be under immense pressure to let the sale resume of Tysabri.
The multiple sclerosis (MS) drug was withdrawn late last February, with dramatic consequences to hopes of sufferers of MS and Crohn's and to the shareholders of Elan and its partner Biogen. Three thousand patients trialled Tysabri in combination with other autoimmune-suppressant drugs. Three of these contracted a rare brain disease, progressive multifocal leukoencephalopathy (PML).
Two of those who contracted the brain disease died, and one survived. Details of the surviving patient have not been released.
The renewed confidence that the drug will be relaunched, which sent Elan shares climbing 14 per cent last week, is not misplaced, according to the person with the closest knowledge of the Tysabri drug, Lars Ekman, Elan's head of global research and development.
Ekman has overseen the development of the drug, seen as the breakthrough treatment for MS and Crohn's before the FDA ordered that its sales be ‘paused' three months ago. The growing confidence within the company is palpable. It is based on the belief that the PML cases were not, as feared, the tip of an iceberg, and that the FDA will allow the drug's return, with revised patient packaging and warnings.
By this summer, the review of the case histories of the 3,000 patients will be completed and after seven weeks of statistical research, an FDA safety committee will be ready to review the drug. Speaking last week to The Sunday Business Post,Ekman said that his confidence was based not on the fact that more patients have not contracted PML, but that he now understood more about the nature of PML.
No patient has contracted PML using Tysabri as a single treatment. “I think that will be a very important distinction when the FDA looks at the data,” said Ekman. “We know from the first months of Tysabri prescription that the vast majority of patients were given monotherapy, and not a combination with other drugs.”
“The reason I am more confident is because I understand more about PML. At the start of this process we thought that you would go to the literature and find, say, that 80 per cent of patients will die from the PML. But all of that data comes from the Aids situation.
“We have looked at other areas which are more relevant to Tysabri - drug-induced PML, where you have an immune-compromised drug. There, the latest literature suggests if you diagnose very early and take away the drug then you have 100 per cent survival.”
Elan will be hoping to show to the FDA safety committee that the patients who died had PML from the beginning, and that the deaths were not necessarily related to their use of Tysabri.
“Both these patients [the fatalities] were on other drugs,” said Ekman. “The Crohn's patient was on a severe immune-suppressant for six years, and it was also disclosed that that patient was on a drug which is known to cause PML. The patient was on Tysabri for a couple of months. “I do not want to give you the conclusion until we and the FDA have a joint conclusion. I can say that these patients were subjected over many years to very potent immune suppressants other than Tysabri, and they were on Tysabri for a couple of months.”
Elan has also expressed confidence that Tysabri's commercial value will not shrink if it is confirmed that Tysabri is an effective treatment for MS when used without combining it with other drugs. Nonetheless, analysts remain skeptical - even if the drug were to come back, they feel, it could be used less in treatments.
But Ekman said that there there was “a huge discrepancy'‘ between the scientific community and Wall Street on the issue. “I have not been overly impressed by Wall Street's analysis of how you do risk analysis assessments,” he said.
He believes that Tysabri was caught up in the storm at the FDA after the US Congress questioned the regulator about its record in monitoring the safety of high-profile drugs. Merck's painkiller Vioxx was withdrawn last September, before the FDA gave the go ahead to market Tysabri after an accelerated trial based on one-year data.
“Congress had a very tough hearing with the FDA executives on Vioxx,” said Ekman. “They came home and there were these two PML cases. And that drastically changed the tone of conversation with FDA. So I can imagine there was a very intense discussion in the FDA.” Many observers last February forecast that the renewed focus on safety would rule out the FDA allowing Tysabri to return any time soon.
So are analysts not right to be skeptical, given the new political reality in the FDA? “I do not know whether anybody knows that,” said Ekman. “The FDA wants to show that they take safety seriously.” The FDA will probably be under pressure because of the large relapse rate for 100,000 MS sufferers in the US who have been on other treatments, argues Ekman.
“We know that they will generate, over the next two years, 53,000 relapses.We also now that if they take Tysabri, that number goes down to approximately 25,000.We also know that 5 per cent of these relapses will lead to severe disability and even cause death,” said Ekman. “The question that the FDA will have to ask is, is the patient better off with Tysabri or without Tysabri. MS is a very serious disease.
“It is not like the Vioxx situation where you have a drug and there are 19 alternatives already on the market. There is no alternative today to Tysabri for these patients.”
If Tysabri was reintroduced with new patient warnings, it would be up to neurologists and the patients to decide whether to take Tysabri, said Ekman.
“We have stopped all dosages.We know that after a certain amount of time the disease will come back, and that will be an important time for 3,000 patients, because the relapses come back. I think that the FDA will be very sensitive to that.
.
Sunday Business Post
FDA will be under pressure to resume sale of MS drug Tysabri
29 May 2005
The way Elan tells it, by the end of this summer the safety panel of the US Food and Drug Administration (FDA) will be under immense pressure to let the sale resume of Tysabri.
The multiple sclerosis (MS) drug was withdrawn late last February, with dramatic consequences to hopes of sufferers of MS and Crohn's and to the shareholders of Elan and its partner Biogen. Three thousand patients trialled Tysabri in combination with other autoimmune-suppressant drugs. Three of these contracted a rare brain disease, progressive multifocal leukoencephalopathy (PML).
Two of those who contracted the brain disease died, and one survived. Details of the surviving patient have not been released.
The renewed confidence that the drug will be relaunched, which sent Elan shares climbing 14 per cent last week, is not misplaced, according to the person with the closest knowledge of the Tysabri drug, Lars Ekman, Elan's head of global research and development.
Ekman has overseen the development of the drug, seen as the breakthrough treatment for MS and Crohn's before the FDA ordered that its sales be ‘paused' three months ago. The growing confidence within the company is palpable. It is based on the belief that the PML cases were not, as feared, the tip of an iceberg, and that the FDA will allow the drug's return, with revised patient packaging and warnings.
By this summer, the review of the case histories of the 3,000 patients will be completed and after seven weeks of statistical research, an FDA safety committee will be ready to review the drug. Speaking last week to The Sunday Business Post,Ekman said that his confidence was based not on the fact that more patients have not contracted PML, but that he now understood more about the nature of PML.
No patient has contracted PML using Tysabri as a single treatment. “I think that will be a very important distinction when the FDA looks at the data,” said Ekman. “We know from the first months of Tysabri prescription that the vast majority of patients were given monotherapy, and not a combination with other drugs.”
“The reason I am more confident is because I understand more about PML. At the start of this process we thought that you would go to the literature and find, say, that 80 per cent of patients will die from the PML. But all of that data comes from the Aids situation.
“We have looked at other areas which are more relevant to Tysabri - drug-induced PML, where you have an immune-compromised drug. There, the latest literature suggests if you diagnose very early and take away the drug then you have 100 per cent survival.”
Elan will be hoping to show to the FDA safety committee that the patients who died had PML from the beginning, and that the deaths were not necessarily related to their use of Tysabri.
“Both these patients [the fatalities] were on other drugs,” said Ekman. “The Crohn's patient was on a severe immune-suppressant for six years, and it was also disclosed that that patient was on a drug which is known to cause PML. The patient was on Tysabri for a couple of months. “I do not want to give you the conclusion until we and the FDA have a joint conclusion. I can say that these patients were subjected over many years to very potent immune suppressants other than Tysabri, and they were on Tysabri for a couple of months.”
Elan has also expressed confidence that Tysabri's commercial value will not shrink if it is confirmed that Tysabri is an effective treatment for MS when used without combining it with other drugs. Nonetheless, analysts remain skeptical - even if the drug were to come back, they feel, it could be used less in treatments.
But Ekman said that there there was “a huge discrepancy'‘ between the scientific community and Wall Street on the issue. “I have not been overly impressed by Wall Street's analysis of how you do risk analysis assessments,” he said.
He believes that Tysabri was caught up in the storm at the FDA after the US Congress questioned the regulator about its record in monitoring the safety of high-profile drugs. Merck's painkiller Vioxx was withdrawn last September, before the FDA gave the go ahead to market Tysabri after an accelerated trial based on one-year data.
“Congress had a very tough hearing with the FDA executives on Vioxx,” said Ekman. “They came home and there were these two PML cases. And that drastically changed the tone of conversation with FDA. So I can imagine there was a very intense discussion in the FDA.” Many observers last February forecast that the renewed focus on safety would rule out the FDA allowing Tysabri to return any time soon.
So are analysts not right to be skeptical, given the new political reality in the FDA? “I do not know whether anybody knows that,” said Ekman. “The FDA wants to show that they take safety seriously.” The FDA will probably be under pressure because of the large relapse rate for 100,000 MS sufferers in the US who have been on other treatments, argues Ekman.
“We know that they will generate, over the next two years, 53,000 relapses.We also now that if they take Tysabri, that number goes down to approximately 25,000.We also know that 5 per cent of these relapses will lead to severe disability and even cause death,” said Ekman. “The question that the FDA will have to ask is, is the patient better off with Tysabri or without Tysabri. MS is a very serious disease.
“It is not like the Vioxx situation where you have a drug and there are 19 alternatives already on the market. There is no alternative today to Tysabri for these patients.”
If Tysabri was reintroduced with new patient warnings, it would be up to neurologists and the patients to decide whether to take Tysabri, said Ekman.
“We have stopped all dosages.We know that after a certain amount of time the disease will come back, and that will be an important time for 3,000 patients, because the relapses come back. I think that the FDA will be very sensitive to that.
.
-
HarryZ
- Family Elder
- Posts: 2572
- Joined: Tue May 25, 2004 2:00 pm
- Location: London, ON, Canada
- Contact:
Re: FDA will be under pressure to resume sale of MS drug Tys
Hmmm......not very good news if this proves to be accurate.
Harry
__________________________________
A fourth death may be tied to Biogen's MS drug
Finding could be blow to marketplace hopes
By Jeffrey Krasner, Globe Staff | June 2, 2005
Biogen Idec Inc. has told the Food and Drug Administration that a fourth patient may have contracted a potentially deadly brain disease after being treated with the company's multiple sclerosis drug Tysabri.
If the case is confirmed, it would deal another blow to multiple sclerosis patients who have been hoping that Tysabri, which has been shown effective in reducing debilitating relapses, might again be made available. Cambridge-based Biogen Idec and its partner in Tysabri, Elan Corp. of Ireland, in February suspended sale of the drug and discontinued clinical trials after it was disclosed that one patient had died of a brain disease known as PML, and another was believed to have it. A third case of the disease was identified in March.
Confirmation of a new case could make it more difficult for the companies to convince the FDA that Tysabri is safe. Because PML is so rare, each additional confirmed case magnifies the drug's potential risks.
FDA spokeswoman Lenore Gelb said the agency is ''in communications with [Biogen Idec] on this case, as well as on the ongoing safety review."
The FDA approved Tysabri in November after reviewing only one year of data from planned two-year trials. It also shortened the approval process to six months from the date the companies submitted their application.
The first two cases of the disease, whose full name is progressive multifocal leukoencephalopathy, surfaced three months after the drug went on sale. PML is a rare brain disease in which a virus damages the central nervous system, often leading to disability and death within months.
The Globe obtained the report of the unconfirmed case under the Freedom of Information Act.
After being provided a copy of the report by the Globe, Dr. Patricia K. Coyle, an MS specialist and acting chairwoman of the Department of Neurology at the State University of New York at Stony Brook, said she thinks the FDA should investigate the new report ''quite vigorously."
The possible fourth PML patient is a 48-year-old woman who was taking Tysabri along with Avonex, another multiple sclerosis drug sold by Biogen Idec.
Dr. Douglas R. Jeffery, a neurologist at Wake Forest University School of Medicine in North Carolina, said the patient's symptoms would be ''quite rare" for multiple sclerosis, supporting the physician's diagnosis of PML. ''It sure sounds convincing to me," Jeffery said.
Jeffery said he is a paid consultant to Biogen Idec, Teva Pharmaceuticals, Serono Pharmaceuticals, Pfizer Inc. and Berlex Laboratories. He said he also receives research funding from the companies. ''I was extraordinarily saddened and disappointed when Tysabri was removed from the market," Jeffery said. ''I view Tysabri as a major advance in MS therapeutics."
A Biogen spokesman, Tim Hunt, declined to comment on the possible new case of PML. ''We're in the middle of our ongoing safety evaluation of Tysabri," he said. ''We hope to have our findings by the end of the summer. Beyond that we're not commenting on the particulars of our ongoing safety review." Biogen said it will discuss its findings with the FDA.
An Elan spokesman, Brian McGlynn, said the company would not comment ''on individual cases until the safety evaluation is completed."
Michael Peskoe, a former FDA attorney now with the Boston law firm Palmer & Dodge LLP, said that because Tysabri is already off the market, there is no obvious action the FDA could take. But the agency wants ''to find out everything they possibly can about Tysabri," he said
The possible new case is the third among multiple sclerosis patients who were taking both Tysabri and Avonex, according to the FDA report. Some doctors have speculated that the two drugs may together sufficiently weaken patients' immune systems to permit infections like PML. The three confirmed PML patients had weakened immune systems, sparking hope that Tysabri could return to the market if it was not used in conjunction with Avonex.
Last Thursday, Kelly Martin, Elan's chief executive, said he was optimistic about Tysabri's eventual return. ''It would be inconceivable to me that the drug wouldn't be available," he said at the company's annual meeting in Dublin.
Based on Martin's comments, shares of Elan and Biogen Idec have risen since Elan's annual meeting. Elan shares yesterday closed at $7.99, up 9 cents. They have surged 166 percent since dropping to $3 after the third patient with PML was revealed on March 30. Biogen shares yesterday gained 67 cents to close at $39.77, nearly its highest close since the third case was disclosed.
Biogen Idec is reviewing medical data from each of the roughly 3,000 patients who took Tysabri for extended periods in clinical trials. Patients are being reexamined by their neurologists. Some are undergoing MRI brain scans and having their spinal fluid tested for the virus that causes PML.
Harry
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A fourth death may be tied to Biogen's MS drug
Finding could be blow to marketplace hopes
By Jeffrey Krasner, Globe Staff | June 2, 2005
Biogen Idec Inc. has told the Food and Drug Administration that a fourth patient may have contracted a potentially deadly brain disease after being treated with the company's multiple sclerosis drug Tysabri.
If the case is confirmed, it would deal another blow to multiple sclerosis patients who have been hoping that Tysabri, which has been shown effective in reducing debilitating relapses, might again be made available. Cambridge-based Biogen Idec and its partner in Tysabri, Elan Corp. of Ireland, in February suspended sale of the drug and discontinued clinical trials after it was disclosed that one patient had died of a brain disease known as PML, and another was believed to have it. A third case of the disease was identified in March.
Confirmation of a new case could make it more difficult for the companies to convince the FDA that Tysabri is safe. Because PML is so rare, each additional confirmed case magnifies the drug's potential risks.
FDA spokeswoman Lenore Gelb said the agency is ''in communications with [Biogen Idec] on this case, as well as on the ongoing safety review."
The FDA approved Tysabri in November after reviewing only one year of data from planned two-year trials. It also shortened the approval process to six months from the date the companies submitted their application.
The first two cases of the disease, whose full name is progressive multifocal leukoencephalopathy, surfaced three months after the drug went on sale. PML is a rare brain disease in which a virus damages the central nervous system, often leading to disability and death within months.
The Globe obtained the report of the unconfirmed case under the Freedom of Information Act.
After being provided a copy of the report by the Globe, Dr. Patricia K. Coyle, an MS specialist and acting chairwoman of the Department of Neurology at the State University of New York at Stony Brook, said she thinks the FDA should investigate the new report ''quite vigorously."
The possible fourth PML patient is a 48-year-old woman who was taking Tysabri along with Avonex, another multiple sclerosis drug sold by Biogen Idec.
Dr. Douglas R. Jeffery, a neurologist at Wake Forest University School of Medicine in North Carolina, said the patient's symptoms would be ''quite rare" for multiple sclerosis, supporting the physician's diagnosis of PML. ''It sure sounds convincing to me," Jeffery said.
Jeffery said he is a paid consultant to Biogen Idec, Teva Pharmaceuticals, Serono Pharmaceuticals, Pfizer Inc. and Berlex Laboratories. He said he also receives research funding from the companies. ''I was extraordinarily saddened and disappointed when Tysabri was removed from the market," Jeffery said. ''I view Tysabri as a major advance in MS therapeutics."
A Biogen spokesman, Tim Hunt, declined to comment on the possible new case of PML. ''We're in the middle of our ongoing safety evaluation of Tysabri," he said. ''We hope to have our findings by the end of the summer. Beyond that we're not commenting on the particulars of our ongoing safety review." Biogen said it will discuss its findings with the FDA.
An Elan spokesman, Brian McGlynn, said the company would not comment ''on individual cases until the safety evaluation is completed."
Michael Peskoe, a former FDA attorney now with the Boston law firm Palmer & Dodge LLP, said that because Tysabri is already off the market, there is no obvious action the FDA could take. But the agency wants ''to find out everything they possibly can about Tysabri," he said
The possible new case is the third among multiple sclerosis patients who were taking both Tysabri and Avonex, according to the FDA report. Some doctors have speculated that the two drugs may together sufficiently weaken patients' immune systems to permit infections like PML. The three confirmed PML patients had weakened immune systems, sparking hope that Tysabri could return to the market if it was not used in conjunction with Avonex.
Last Thursday, Kelly Martin, Elan's chief executive, said he was optimistic about Tysabri's eventual return. ''It would be inconceivable to me that the drug wouldn't be available," he said at the company's annual meeting in Dublin.
Based on Martin's comments, shares of Elan and Biogen Idec have risen since Elan's annual meeting. Elan shares yesterday closed at $7.99, up 9 cents. They have surged 166 percent since dropping to $3 after the third patient with PML was revealed on March 30. Biogen shares yesterday gained 67 cents to close at $39.77, nearly its highest close since the third case was disclosed.
Biogen Idec is reviewing medical data from each of the roughly 3,000 patients who took Tysabri for extended periods in clinical trials. Patients are being reexamined by their neurologists. Some are undergoing MRI brain scans and having their spinal fluid tested for the virus that causes PML.
Last edited by HarryZ on Thu Jun 02, 2005 7:58 am, edited 1 time in total.
Regarding the Boston Globe article stating that there MAY have been a 4th death...
Biogen refuted the Globe report early Thursday, stating that only two PML patients have died, while a third victim survived. The company would not comment on the specifics of the fourth case in question, stating only the patient was alive.
"The patient that the Globe referenced is definitely alive," said Biogen spokeswoman Amy Brockelman. "We're not commenting on any of the other specifics in the article."
Biogen refuted the Globe report early Thursday, stating that only two PML patients have died, while a third victim survived. The company would not comment on the specifics of the fourth case in question, stating only the patient was alive.
"The patient that the Globe referenced is definitely alive," said Biogen spokeswoman Amy Brockelman. "We're not commenting on any of the other specifics in the article."
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HarryZ
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Denver,
I'm presuming that Jeff Krasner of the Globe had a very good source before he printed that article. Being physically so close to Biogen's HQ, I'm sure he has some "contacts" that provide him with the info.
If indeed this story is accurate, one interesting point comes up....Tysabri supposedly hasn't been used on any MS or Crohn's patients for over 2 months now but another suspected case of PML has surfaced. We certainly don't have any time lines for this situation as yet but that would possibly throw another curve in the Tysabri/PML scenario.
Harry
I'm presuming that Jeff Krasner of the Globe had a very good source before he printed that article. Being physically so close to Biogen's HQ, I'm sure he has some "contacts" that provide him with the info.
If indeed this story is accurate, one interesting point comes up....Tysabri supposedly hasn't been used on any MS or Crohn's patients for over 2 months now but another suspected case of PML has surfaced. We certainly don't have any time lines for this situation as yet but that would possibly throw another curve in the Tysabri/PML scenario.
Harry
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better2gether
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Biogen rebuttal
Biogen rebuttal
Biogen rebutted the Globe report early Thursday, stating that only two PML patients had died, while the third victim had survived. The company would not comment on the specifics of the fourth case in question, stating only that the patient was alive.
"The patient that the Globe referenced is definitely alive," said Biogen spokeswoman Amy Brockelman. "We're not commenting on any of the other specifics in the article."
"We're continuing to review any and all suspected cases," Brockelman added, saying that Biogen still hoped to have the review completed by the end of the summer.
Biogen has said that it plans to meet with the FDA as to the advisability of putting Tysabri back on the market after the medical review is complete.
<shortened url>
Harry,
If Jeff Krasner of the Globe had a very good source before he printed that article, why is he talking about a fourth death ?
Better
Biogen rebutted the Globe report early Thursday, stating that only two PML patients had died, while the third victim had survived. The company would not comment on the specifics of the fourth case in question, stating only that the patient was alive.
"The patient that the Globe referenced is definitely alive," said Biogen spokeswoman Amy Brockelman. "We're not commenting on any of the other specifics in the article."
"We're continuing to review any and all suspected cases," Brockelman added, saying that Biogen still hoped to have the review completed by the end of the summer.
Biogen has said that it plans to meet with the FDA as to the advisability of putting Tysabri back on the market after the medical review is complete.
<shortened url>
Harry,
If Jeff Krasner of the Globe had a very good source before he printed that article, why is he talking about a fourth death ?
Better