BIOGEN que houve?
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In the wake of Tysabri's withdrawal, senior figures at Biogen Idec have admitted they sold large volumes of their company's shares in the week before the announcement but have denied any wrongdoing.
HE HE HE HE
"Now i am the master!"
Frase proferida por Warren Buffett ao seu velho mestre Ben Graham, quando este jazia em seu leito de morte.
Frase proferida por Warren Buffett ao seu velho mestre Ben Graham, quando este jazia em seu leito de morte.
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- Mensagens: 418
- Registado: 16/10/2003 9:41
- Localização: LISBOA
Elan, Biogen Confirm Second Patient Death
03.04.2005, 04:10 AM
A second patient taking a recently suspended multiple sclerosis-fighting drug, Tysabri, has died from a rare disease, the Irish and American companies who jointly developed the highly touted medication said Friday.
Elan Corp. of Ireland and Biogen Idec Inc. of Cambridge, Massachusetts, on Monday announced they were withdrawing Tysabri because one patient had died of progressive multifocal leukoencephalopathy, a usually fatal disease of the central nervous system, while a second patient had also developed PML.
The two companies confirmed Friday that the second patient had also died.
Tysabri had been approved in November by the U.S. Food and Drug Administration following promising clinical trials that demonstrated the drug's ability to prevent relapses in many MS sufferers.
The drug was being used by about 3,000 MS sufferers in the United States and 22 people in Ireland before its withdrawal from the market. Tysabri was also withdrawn from clinical trials on sufferers of Crohn's disease and rheumatoid arthritis.
Both patients who died were taking Tysabri with Avonex, an older MS-fighting drug developed by Biogen Idec. It has remained on the market.
And the two companies stressed in a joint statement that, for now, there was no evidence that either drug taken on its own was linked to PML.
"To date, the companies have received no reports of PML in patients receiving Tysabri monotherapy for MS or in patients with Crohn's disease or rheumatoid arthritis," the companies said. "Biogen Idec has not received any reports of PML in patients treated with Avonex alone, a product on the market since 1996."
The companies also confirmed they both were providing unspecified new information to the U.S. Securities and Exchange Commission, which spent two years investigating accounting malpractice at Elan. The Irish company last month paid US$15 million (euro11.4 million) to the SEC to settle the probe.
In the wake of Tysabri's withdrawal, senior figures at Biogen Idec have admitted they sold large volumes of their company's shares in the week before the announcement but have denied any wrongdoing.
Shares in both Elan and Biogen Idec have been hammered this week, losing more than half their value. Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin, said confirmation of the second death would put more pressure on the companies' market values.
Previously, Elan chief executive Kelly Martin has insisted that the company was hopeful of reintroducing Tysabri - Elan's key drug - to the market later this year.
A second patient taking a recently suspended multiple sclerosis-fighting drug, Tysabri, has died from a rare disease, the Irish and American companies who jointly developed the highly touted medication said Friday.
Elan Corp. of Ireland and Biogen Idec Inc. of Cambridge, Massachusetts, on Monday announced they were withdrawing Tysabri because one patient had died of progressive multifocal leukoencephalopathy, a usually fatal disease of the central nervous system, while a second patient had also developed PML.
The two companies confirmed Friday that the second patient had also died.
Tysabri had been approved in November by the U.S. Food and Drug Administration following promising clinical trials that demonstrated the drug's ability to prevent relapses in many MS sufferers.
The drug was being used by about 3,000 MS sufferers in the United States and 22 people in Ireland before its withdrawal from the market. Tysabri was also withdrawn from clinical trials on sufferers of Crohn's disease and rheumatoid arthritis.
Both patients who died were taking Tysabri with Avonex, an older MS-fighting drug developed by Biogen Idec. It has remained on the market.
And the two companies stressed in a joint statement that, for now, there was no evidence that either drug taken on its own was linked to PML.
"To date, the companies have received no reports of PML in patients receiving Tysabri monotherapy for MS or in patients with Crohn's disease or rheumatoid arthritis," the companies said. "Biogen Idec has not received any reports of PML in patients treated with Avonex alone, a product on the market since 1996."
The companies also confirmed they both were providing unspecified new information to the U.S. Securities and Exchange Commission, which spent two years investigating accounting malpractice at Elan. The Irish company last month paid US$15 million (euro11.4 million) to the SEC to settle the probe.
In the wake of Tysabri's withdrawal, senior figures at Biogen Idec have admitted they sold large volumes of their company's shares in the week before the announcement but have denied any wrongdoing.
Shares in both Elan and Biogen Idec have been hammered this week, losing more than half their value. Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin, said confirmation of the second death would put more pressure on the companies' market values.
Previously, Elan chief executive Kelly Martin has insisted that the company was hopeful of reintroducing Tysabri - Elan's key drug - to the market later this year.
Um abraço,
JAOliveira
JAOliveira
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- Mensagens: 231
- Registado: 14/2/2005 2:19
- Localização: Guimarães
O motivo por trás da queda de ontem pode ser a notícia de que identificaram um segundo caso de complicações pelo uso do seu medicamento.
2:36am 03/04/05
Elan, Biogen: Second Tysabri PML case confirmed (BIIB, ELN, UK:ELA) By Emily Church
LONDON (MarketWatch) -- Pharmaceuticals makers Biogen Idec (BIIB) and Ireland's Elan Corp. (UK:ELA) (ELN) said the second case of progressive multifocal leukoencephalopathy (PML) has been confirmed in a patient who received Tysabri therapy in combination with Avonex. The companies suspended marketing Tysabri on Feb. 28 after one confirmed PML case and a second suspected case. The companies also said they are cooperating with the Securities and Exchange Commission and have provided information over the suspension of Tysabri.
nuno, achas mesmo que ela vai assim tão para baixo? Ela me parece que está a se aguentar bem na zona dos 40,00 $.
2:36am 03/04/05
Elan, Biogen: Second Tysabri PML case confirmed (BIIB, ELN, UK:ELA) By Emily Church
LONDON (MarketWatch) -- Pharmaceuticals makers Biogen Idec (BIIB) and Ireland's Elan Corp. (UK:ELA) (ELN) said the second case of progressive multifocal leukoencephalopathy (PML) has been confirmed in a patient who received Tysabri therapy in combination with Avonex. The companies suspended marketing Tysabri on Feb. 28 after one confirmed PML case and a second suspected case. The companies also said they are cooperating with the Securities and Exchange Commission and have provided information over the suspension of Tysabri.
nuno, achas mesmo que ela vai assim tão para baixo? Ela me parece que está a se aguentar bem na zona dos 40,00 $.
"Now i am the master!"
Frase proferida por Warren Buffett ao seu velho mestre Ben Graham, quando este jazia em seu leito de morte.
Frase proferida por Warren Buffett ao seu velho mestre Ben Graham, quando este jazia em seu leito de morte.
-
- Mensagens: 418
- Registado: 16/10/2003 9:41
- Localização: LISBOA
As notícias não me soam como animadoras. Mas talvez a confiança seja reestabelecida uma vez que deverão continuar a utilizar a medicação como último recurso.
Talvez seja preferível segurar as acções e aguardar uma subida em vez de perder já.
O que pensam?
Talvez seja preferível segurar as acções e aguardar uma subida em vez de perder já.
O que pensam?
- Mensagens: 17
- Registado: 24/2/2005 4:20
Depois do "cataclismo", há 3 sessões seguidas em que só há fechos positivos.
As notícias são muito negativas, mas alguns investidores podem estar a se aproveitar do momento para tentar extrair algumas mais valias.
Aqui vai a notícia:
Recall Routs Biogen, Elan
By Robert Steyer
TheStreet.com Staff Reporter
2/28/2005 5:16 PM EST
URL: http://www.thestreet.com/stocks/roberts ... 10803.html
Updated from 3:07 p.m. EST
Shares in Biogen Idec (BIIB:Nasdaq) and its partner Elan (ELN:NYSE) plunged Monday after they suspended sales of their multiple sclerosis drug Tysabri.
One patient died after taking Tysabri for more than two years with Avonex, an MS drug made by Biogen Idec. They also cited a second patient suspected of developing the rare and often fatal central nervous system disease called progressive multifocal leukoencephalopathy, or PML.
"The companies are suspending supply of Tysabri from commercial distribution, and physicians should suspend dosing of Tysabri until further notification," Biogen Idec and Elan said. "In addition, the companies have suspended dosing in all clinical trials." Tysabri was cleared for marketing by the FDA in November.
Despite the stunning revelation about a drug that Standard & Poor's recently pegged as one of the top 10 drugs to watch this year, Kelly Martin, CEO of Elan, said "a realistic timeline" for returning the drug to the marketplace would be late summer or fall, assuming a detailed review shows no potential widespread dangers, and assuming the Food and Drug Administration agrees.
Martin told analysts in a telephone conference that the withdrawal of Tysabri was the result of a "collaborative discussion" between Elan and Biogen Idec with the FDA. The agency didn't order the drug off the market, he said. The FDA wants this drug on the market due to its effectiveness, Martin said.
Still, Tysabri is the first biotech drug to be withdrawn from the market, said Steven Harr, a biotech analyst at Morgan Stanley, in a research note to clients on Monday.
Biogen Idec fell $28.63, or 42.6%, to $38.65 as four investment banking firms cut their ratings. Elan fared even worse, diving $18.90, or 70%, to $8.
Morningstar placed both companies under review. "The withdrawal is likely to hit Elan especially hard because the firm's pipeline, aside from Tysabri, is relatively weak and still in the early stages of development," said a Monday report from Morningstar analysts who don't own shares in the companies and whose firm doesn't have an investment-banking relationship.
"This is a near-term challenge for us," said Martin, adding that Elan will "act decisively" on contingency plans when and if necessary. "We feel like we still have very good assets in the company," he said.
Biogen Idec executives said it was too soon to assess the economic impact of withdrawing the drug.
The market reaction brought back memories of Merck's (MRK:NYSE) pounding in September, when it voluntarily recalled the arthritis drug Vioxx, a development that led to questions about the approval process at the Food and Drug Administration.
Merck cited the results of a company-sponsored clinical trial that showed patients taking Vioxx for longer than 18 months had a higher cardiovascular disease risk than did patients taking a placebo. But Merck recently hinted that it might return Vioxx to the market, assuming the Food and Drug Administration approves, given recent studies that, Merck says, suggests similar drugs may present cardiovascular risk. Those drugs include Pfizer's (PFE:NYSE) Celebrex and Bextra.
Assessing a Problem
The specter of Vioxx surfaced during a Biogen Idec telephone conference call Monday when a reporter asked executives if Merck's experience played any role in their decision with Tysabri. Jim Mullen, the CEO, said the only issue was the MS patients' safety.
"We keep the patient at the center of this," he said. Mullen said the decision to stop selling the drug and to stop tests of Tysabri on other diseases enables the companies "to step back" and evaluate whether there is a problem with Tysabri alone or with Tysabri in combination with Avonex.
To date, the companies said there are no reports of PML in multiple sclerosis patients receiving Tysabri alone or in patients with Crohn's disease or rheumatoid arthritis participating in clinical trials.
Biogen Idec has received no reports of PML in patients treated with Avonex alone, a product that has been on the market since 1996. Before Monday, the big question was to what degree the jointly marketed Tysabri would damage sales of Avonex or whether physicians would prescribe the two drugs as a joint treatment.
Elan's Martin said Monday that the two patients identified with PML were receiving "multiple therapies for multiple medical issues." But because the companies couldn't rule out the impact of Avonex plus Tysabri on these patients, "we took this step" of suspending the drug from the marketplace, he said.
Tysabri is approved for relapsing-remitting MS, the most common form of the disease at the time of diagnosis. It is characterized by acute symptoms or a worsening of neurological functions that can occur intermittently. These symptoms can weaken or disappear for months or years between relapses.
"Our ongoing commitment to MS patients has led us to take these steps," said Dr. Burt Adelman, executive vice president for development at Biogen Idec. "Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations."
Dr. Lars Ekman, executive vice president for Elan added: "We are working with leading experts and regulatory agencies to responsibly investigate these events and to develop the appropriate path forward. Our primary concern is for the safety of patients."
In a telephone conference call with reporters and analysts, Biogen Idec executives said they moved quickly to inform the FDA about the reports of PML cases.
"We have been in close contact with the FDA in the last few days after we got news of the side effects cases," Adelman said. "It was a very rapid process."
"We acted swiftly," said Mullen. He didn't provide a specific timeline, but he noted that "these events popped up" since the companies issued a press release Feb. 17 on progress of a Tysabri clinical trial. In that announcement, the companies said results from a clinical trial spanning 24 months confirmed the results of a clinical trial of 12 months that was a basis for the drug's approval by the FDA in November. Complete details of the research will be presented at a major medical conference in April, and the test results will be submitted to regulators.
The two-year results as well as the reported side effects were consistent with the one-year results, the companies said of the research that evaluated 942 patients at 99 clinical sites worldwide.
Wall Street Reaction
Not surprisingly, Wall Street reacted with shock to the results and concern about the companies' prospects.
"Tysabri [is] now damaged goods," said the SG Cowen investment banking firm in a a report to clients on Monday.
"Although it is unclear what role Tysabri played in these adverse events or whether Tysabri monotherapy is associated with similar risks," removing the drug from the market "will make reintroduction challenging and will likely reduce any future revenue contribution from the drug," said the report from Cowen, whose analysts don't own shares. Cowen doesn't offer stock ratings; the firm is a market maker in Biogen Idec's stock.
Cowen analysts have removed the drug from their revenue estimates for Biogen Idec. "Should Tysabri be reintroduced, physicians and patients are likely to be very cautious in returning to the therapy," the report said.
That gloomy assessment was supported by several neurologists participating in a conference call held by Leerink Swann & Co. The doctors predicted it might take a few years rather than a few months for the drug to return to the market, according to one source, and that a resurrected drug would be subject to greater restrictions.
Deutsche Bank Securities Jennifer Chao cut her rating on Biogen Idec to sell from buy, telling clients Monday that the drug's fate is affected by "complexity and uncertainty." She removed Tysabri's sales from her financial projections in 2005 and 2006. (She doesn't own shares; her firm says it does and seeks to do business with companies mentioned in research reports.)
"Long-term growth faces serious threats," said Morgan Stanley's Steven Harr, who had an overweight rating on Biogen Idec but who now is "reviewing our model for more information."
Harr, whose comments were issued before the companies teleconference, said that until they provide greater details, "the long-term implications are difficult to assess." He speculated that Tysabri might return to the market to a more restricted patient population.
"Given that this drug was approved under accelerated approval statute, we surmise that the FDA has a lower tolerance for safety issues until it sees the full two-year [clinical trial] data," he said. (Harr doesn't own shares. His firm is a market maker in Biogen Idec's stock and has provided non-investment-banking services for Biogen Idec.)
The companies sought and received rapid FDA approval after what was considered extreme successful early phase III clinical testing. (The companies agreed to continue phase III testing as part of the approval process.)
The setback could run deep. Tysabri is being tested for other uses. For example, Biogen Idec had expected phase II clinical trial results in mid-2005 for Tysabri as a treatment for rheumatoid arthritis. Phase II is the second of three rounds of clinical tests before a drug is submitted to regulators.
Tyasbri is also being tested as a treatment for the chronic, debilitating gastrointestinal ailment called Crohn's disease. In September, the companies filed an application with the European Union for this indication.
Test results from another phase III test are due in mid-2005; previously, the companies had said they would decide about seeking U.S. approval after the results were evaluated. Biogen Idec executives said Monday that applications for new approvals will be delayed while the side-effects reports are analyzed. They said they were in contact with the European Union's counterpart of the FDA.
CEO Mullen said it is too early for Biogen Idec to assess the impact on upcoming sales and earnings. He noted that Biogen Idec had hired about 450 people to launch Tysabri, but he said it is "premature" to comment on what might happen to them. Biogen Idec has about 5,000 employees.
Mullen said he couldn't immediately predict the cost of the recall, adding that he couldn't predict whether Biogen Idec would have to take a reserve to account for potential litigation.
The move boosted shares of some rival drugmakers with competing treatments: Chiron (CHIR:Nasdaq) rose 43 cents, or 1.2%, to $35.44, and Teva Pharmaceutical (TEVA:Nasdaq) jumped $2.09, or 7.6% to $29.65, and Serono (SRA:NYSE) rose $2.76, or 17.8%, to $18.30.
Medical Impact
Biogen and Idec also issued a "Dear Health Care Provider" letter explaining their actions. The letter notes that the two reports of PML occurred in one patient treated for 28 months and another patient treated for 28 months with both Tysabri and Avonex. The patients had no other complicating factors, such as a suppressed immune system or HIV.
The companies said about 3,000 patients had been treated with Tysabri in clinical trials for MS, Crohn's disease and rheumatoid arthritis. They said there were no reports of PML in patients receiving just Tysabri or just Avonex nor did they receive any reports of PML with patients suffering from Crohn's disease or rheumatoid arthritis in clinical trials.
Adelman told analysts and reporters Monday the companies would convene a group of experts to determine if the reports of PML are linked to the length of treatment and to the form of treatment.
As notícias são muito negativas, mas alguns investidores podem estar a se aproveitar do momento para tentar extrair algumas mais valias.
Aqui vai a notícia:
Recall Routs Biogen, Elan
By Robert Steyer
TheStreet.com Staff Reporter
2/28/2005 5:16 PM EST
URL: http://www.thestreet.com/stocks/roberts ... 10803.html
Updated from 3:07 p.m. EST
Shares in Biogen Idec (BIIB:Nasdaq) and its partner Elan (ELN:NYSE) plunged Monday after they suspended sales of their multiple sclerosis drug Tysabri.
One patient died after taking Tysabri for more than two years with Avonex, an MS drug made by Biogen Idec. They also cited a second patient suspected of developing the rare and often fatal central nervous system disease called progressive multifocal leukoencephalopathy, or PML.
"The companies are suspending supply of Tysabri from commercial distribution, and physicians should suspend dosing of Tysabri until further notification," Biogen Idec and Elan said. "In addition, the companies have suspended dosing in all clinical trials." Tysabri was cleared for marketing by the FDA in November.
Despite the stunning revelation about a drug that Standard & Poor's recently pegged as one of the top 10 drugs to watch this year, Kelly Martin, CEO of Elan, said "a realistic timeline" for returning the drug to the marketplace would be late summer or fall, assuming a detailed review shows no potential widespread dangers, and assuming the Food and Drug Administration agrees.
Martin told analysts in a telephone conference that the withdrawal of Tysabri was the result of a "collaborative discussion" between Elan and Biogen Idec with the FDA. The agency didn't order the drug off the market, he said. The FDA wants this drug on the market due to its effectiveness, Martin said.
Still, Tysabri is the first biotech drug to be withdrawn from the market, said Steven Harr, a biotech analyst at Morgan Stanley, in a research note to clients on Monday.
Biogen Idec fell $28.63, or 42.6%, to $38.65 as four investment banking firms cut their ratings. Elan fared even worse, diving $18.90, or 70%, to $8.
Morningstar placed both companies under review. "The withdrawal is likely to hit Elan especially hard because the firm's pipeline, aside from Tysabri, is relatively weak and still in the early stages of development," said a Monday report from Morningstar analysts who don't own shares in the companies and whose firm doesn't have an investment-banking relationship.
"This is a near-term challenge for us," said Martin, adding that Elan will "act decisively" on contingency plans when and if necessary. "We feel like we still have very good assets in the company," he said.
Biogen Idec executives said it was too soon to assess the economic impact of withdrawing the drug.
The market reaction brought back memories of Merck's (MRK:NYSE) pounding in September, when it voluntarily recalled the arthritis drug Vioxx, a development that led to questions about the approval process at the Food and Drug Administration.
Merck cited the results of a company-sponsored clinical trial that showed patients taking Vioxx for longer than 18 months had a higher cardiovascular disease risk than did patients taking a placebo. But Merck recently hinted that it might return Vioxx to the market, assuming the Food and Drug Administration approves, given recent studies that, Merck says, suggests similar drugs may present cardiovascular risk. Those drugs include Pfizer's (PFE:NYSE) Celebrex and Bextra.
Assessing a Problem
The specter of Vioxx surfaced during a Biogen Idec telephone conference call Monday when a reporter asked executives if Merck's experience played any role in their decision with Tysabri. Jim Mullen, the CEO, said the only issue was the MS patients' safety.
"We keep the patient at the center of this," he said. Mullen said the decision to stop selling the drug and to stop tests of Tysabri on other diseases enables the companies "to step back" and evaluate whether there is a problem with Tysabri alone or with Tysabri in combination with Avonex.
To date, the companies said there are no reports of PML in multiple sclerosis patients receiving Tysabri alone or in patients with Crohn's disease or rheumatoid arthritis participating in clinical trials.
Biogen Idec has received no reports of PML in patients treated with Avonex alone, a product that has been on the market since 1996. Before Monday, the big question was to what degree the jointly marketed Tysabri would damage sales of Avonex or whether physicians would prescribe the two drugs as a joint treatment.
Elan's Martin said Monday that the two patients identified with PML were receiving "multiple therapies for multiple medical issues." But because the companies couldn't rule out the impact of Avonex plus Tysabri on these patients, "we took this step" of suspending the drug from the marketplace, he said.
Tysabri is approved for relapsing-remitting MS, the most common form of the disease at the time of diagnosis. It is characterized by acute symptoms or a worsening of neurological functions that can occur intermittently. These symptoms can weaken or disappear for months or years between relapses.
"Our ongoing commitment to MS patients has led us to take these steps," said Dr. Burt Adelman, executive vice president for development at Biogen Idec. "Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations."
Dr. Lars Ekman, executive vice president for Elan added: "We are working with leading experts and regulatory agencies to responsibly investigate these events and to develop the appropriate path forward. Our primary concern is for the safety of patients."
In a telephone conference call with reporters and analysts, Biogen Idec executives said they moved quickly to inform the FDA about the reports of PML cases.
"We have been in close contact with the FDA in the last few days after we got news of the side effects cases," Adelman said. "It was a very rapid process."
"We acted swiftly," said Mullen. He didn't provide a specific timeline, but he noted that "these events popped up" since the companies issued a press release Feb. 17 on progress of a Tysabri clinical trial. In that announcement, the companies said results from a clinical trial spanning 24 months confirmed the results of a clinical trial of 12 months that was a basis for the drug's approval by the FDA in November. Complete details of the research will be presented at a major medical conference in April, and the test results will be submitted to regulators.
The two-year results as well as the reported side effects were consistent with the one-year results, the companies said of the research that evaluated 942 patients at 99 clinical sites worldwide.
Wall Street Reaction
Not surprisingly, Wall Street reacted with shock to the results and concern about the companies' prospects.
"Tysabri [is] now damaged goods," said the SG Cowen investment banking firm in a a report to clients on Monday.
"Although it is unclear what role Tysabri played in these adverse events or whether Tysabri monotherapy is associated with similar risks," removing the drug from the market "will make reintroduction challenging and will likely reduce any future revenue contribution from the drug," said the report from Cowen, whose analysts don't own shares. Cowen doesn't offer stock ratings; the firm is a market maker in Biogen Idec's stock.
Cowen analysts have removed the drug from their revenue estimates for Biogen Idec. "Should Tysabri be reintroduced, physicians and patients are likely to be very cautious in returning to the therapy," the report said.
That gloomy assessment was supported by several neurologists participating in a conference call held by Leerink Swann & Co. The doctors predicted it might take a few years rather than a few months for the drug to return to the market, according to one source, and that a resurrected drug would be subject to greater restrictions.
Deutsche Bank Securities Jennifer Chao cut her rating on Biogen Idec to sell from buy, telling clients Monday that the drug's fate is affected by "complexity and uncertainty." She removed Tysabri's sales from her financial projections in 2005 and 2006. (She doesn't own shares; her firm says it does and seeks to do business with companies mentioned in research reports.)
"Long-term growth faces serious threats," said Morgan Stanley's Steven Harr, who had an overweight rating on Biogen Idec but who now is "reviewing our model for more information."
Harr, whose comments were issued before the companies teleconference, said that until they provide greater details, "the long-term implications are difficult to assess." He speculated that Tysabri might return to the market to a more restricted patient population.
"Given that this drug was approved under accelerated approval statute, we surmise that the FDA has a lower tolerance for safety issues until it sees the full two-year [clinical trial] data," he said. (Harr doesn't own shares. His firm is a market maker in Biogen Idec's stock and has provided non-investment-banking services for Biogen Idec.)
The companies sought and received rapid FDA approval after what was considered extreme successful early phase III clinical testing. (The companies agreed to continue phase III testing as part of the approval process.)
The setback could run deep. Tysabri is being tested for other uses. For example, Biogen Idec had expected phase II clinical trial results in mid-2005 for Tysabri as a treatment for rheumatoid arthritis. Phase II is the second of three rounds of clinical tests before a drug is submitted to regulators.
Tyasbri is also being tested as a treatment for the chronic, debilitating gastrointestinal ailment called Crohn's disease. In September, the companies filed an application with the European Union for this indication.
Test results from another phase III test are due in mid-2005; previously, the companies had said they would decide about seeking U.S. approval after the results were evaluated. Biogen Idec executives said Monday that applications for new approvals will be delayed while the side-effects reports are analyzed. They said they were in contact with the European Union's counterpart of the FDA.
CEO Mullen said it is too early for Biogen Idec to assess the impact on upcoming sales and earnings. He noted that Biogen Idec had hired about 450 people to launch Tysabri, but he said it is "premature" to comment on what might happen to them. Biogen Idec has about 5,000 employees.
Mullen said he couldn't immediately predict the cost of the recall, adding that he couldn't predict whether Biogen Idec would have to take a reserve to account for potential litigation.
The move boosted shares of some rival drugmakers with competing treatments: Chiron (CHIR:Nasdaq) rose 43 cents, or 1.2%, to $35.44, and Teva Pharmaceutical (TEVA:Nasdaq) jumped $2.09, or 7.6% to $29.65, and Serono (SRA:NYSE) rose $2.76, or 17.8%, to $18.30.
Medical Impact
Biogen and Idec also issued a "Dear Health Care Provider" letter explaining their actions. The letter notes that the two reports of PML occurred in one patient treated for 28 months and another patient treated for 28 months with both Tysabri and Avonex. The patients had no other complicating factors, such as a suppressed immune system or HIV.
The companies said about 3,000 patients had been treated with Tysabri in clinical trials for MS, Crohn's disease and rheumatoid arthritis. They said there were no reports of PML in patients receiving just Tysabri or just Avonex nor did they receive any reports of PML with patients suffering from Crohn's disease or rheumatoid arthritis in clinical trials.
Adelman told analysts and reporters Monday the companies would convene a group of experts to determine if the reports of PML are linked to the length of treatment and to the form of treatment.
"Now i am the master!"
Frase proferida por Warren Buffett ao seu velho mestre Ben Graham, quando este jazia em seu leito de morte.
Frase proferida por Warren Buffett ao seu velho mestre Ben Graham, quando este jazia em seu leito de morte.
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- Mensagens: 418
- Registado: 16/10/2003 9:41
- Localização: LISBOA
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