I don't know too many people that have used Tysabri to treat Crohn's, but it is back in the news again for it's lethal side effects. Business Week article is below.
Biogen Idec Inc. has reported a new case of a potentially lethal brain inflammation in a patient using its drug Tysabri, the tenth such case since the drug was reintroduced three years ago.
The company said late Friday it confirmed the presence of progressive multifocal leukoencephalopathy, or PML, on Tuesday. Biogen said the patient, who lives outside the U.S., had been using Tysabri for 30 months. Three of the ten cases of PML have been confirmed this month. In morning trading, shares of Cambridge, Mass.-based Biogen slid $2.86, or 5.7 percent, to $47.21.
Tysabri is approved as a treatment for multiple sclerosis and Crohn's disease. It was pulled from the market in 2005 due to concerns about PML, and sales resumed in July 2006 with restrictions and a monitoring program.
The ten confirmed PML cases have all been in multiple sclerosis patients, and concerns about the disease have pressured sales of the drug.
Biogen said there were about 40,000 patients on Tysabri at the end of March, with 20,800 of them in the U.S. Deutsche Bank analyst Mark Schoenebaum said in a note that the rate of PML infections in Tysabri patients is less than one in a thousand, for patients who have been on the drug for two years. He said the average time on Tysabri for the PML cases is 24 months, and that as more new infections appear, doctors may start taking patients off Tysabri sooner, or giving patients breaks from the drug.
Schoenebaum said that could "dramatically" reduce sales growth. Biogen markets Tysabri with Irish drug maker Elan Corp. PLC, whose shares dipped 38 cents, or 5.2 percent, to $6.98. Shares of PDL BioPharma Inc., which developed the drug and receives royalties on sales from Elan, declined 6 cents to $7.90.
Showing posts with label Tysabri and Crohn's. Show all posts
Showing posts with label Tysabri and Crohn's. Show all posts
Monday, June 29, 2009
Thursday, October 16, 2008
Tysabri, a Crohn's Drug by Elan Corp. - ELan Closing Offices
UPDATE December 12th -
Biotechnology firm Elan Corp. said Friday it is closing its offices in New York and Tokyo during the first quarter as it realigns operations.
Elan said it will eliminate an unspecified number of positions and revise its marketing activities for Tysabri as a treatment for Crohn's disease.
Elan said it will direct additional capital toward research and development. Elan is transitioning from a traditional sales model to one based on clinical support and education, the company said in a statement.
First, about the drug: Tysabri is an antibody, a protein that triggers specific reactions from the body's immune system. Doctors think it helps some people with MS or Crohn's because of way it interacts with natural chemical markers on the surface of cells affected by the diseases. The same markers are found on the myeloma cells that Mr. Baron has, so doctors think the drug may help treat that cancer.
The issue: Dallas lawyer and Democratic Party fundraiser Fred Baron is dying of cancer -- and fighting a drug company for use of an experimental medication, according to his son, Andrew Baron.
Mr. Baron's family says it has enlisted some famous names to lobby on his behalf: Lance Armstrong, the bicyclist and cancer survivor; Bill and Hillary Rodham Clinton; Sen. John Kerry, D-Mass; and Sen. Edward Kennedy, D-Mass., who has brain cancer.
No one can accuse Biogen Idec of playing favorites. The company has been under assault by luminaries from Bill and Hillary Clinton to Lance Armstrong, who are trying to get Biogen's Tysabri drug for Fred Baron, a legal bigwig who's dying of multiple myeloma. Tysabri is in Phase I testing in multiple myeloma patients. But Baron doesn't meet the trial criteria. And Biogen has an ironclad policy of refusing the med for so-called "compassionate use."
Biogen's reasoning is rooted in Tysabri's complex biography. As you all know, the drug was hailed as a major breakthrough for multiple sclerosis patients after its first launch, but then was pulled off the market in February 2005 because of links to a potentially fatal brain infection, PML. The drug was reintroduced in 2006 under a restrictive access program. Since then, Tysabri has won a broader market, with an approval to treat Crohn's disease. It's also seen a couple of new cases of PML in Europe; those cases were added to Tysabri's labeling.
Biogen CEO Jim Mullen has held up under the assault of publicity ginned up on Baron's behalf. Calls from the likes of Armstrong, Ted Kennedy, the Clintons, John Kerry and Henry Waxman haven't swayed him. The company doesn't want to set a precedent by allowing Baron to use Tysabri, given the PML risks--and the risk to Tysabri's future should Baron experience an adverse reaction. "We want to protect access for patients who are on the drug now and rely on it," a Biogen spokeswoman told Pharmalot. "We feel like we can't make an exception in this case."
Biotechnology firm Elan Corp. said Friday it is closing its offices in New York and Tokyo during the first quarter as it realigns operations.
Elan said it will eliminate an unspecified number of positions and revise its marketing activities for Tysabri as a treatment for Crohn's disease.
Elan said it will direct additional capital toward research and development. Elan is transitioning from a traditional sales model to one based on clinical support and education, the company said in a statement.
First, about the drug: Tysabri is an antibody, a protein that triggers specific reactions from the body's immune system. Doctors think it helps some people with MS or Crohn's because of way it interacts with natural chemical markers on the surface of cells affected by the diseases. The same markers are found on the myeloma cells that Mr. Baron has, so doctors think the drug may help treat that cancer.
The issue: Dallas lawyer and Democratic Party fundraiser Fred Baron is dying of cancer -- and fighting a drug company for use of an experimental medication, according to his son, Andrew Baron.
Mr. Baron's family says it has enlisted some famous names to lobby on his behalf: Lance Armstrong, the bicyclist and cancer survivor; Bill and Hillary Rodham Clinton; Sen. John Kerry, D-Mass; and Sen. Edward Kennedy, D-Mass., who has brain cancer.
No one can accuse Biogen Idec of playing favorites. The company has been under assault by luminaries from Bill and Hillary Clinton to Lance Armstrong, who are trying to get Biogen's Tysabri drug for Fred Baron, a legal bigwig who's dying of multiple myeloma. Tysabri is in Phase I testing in multiple myeloma patients. But Baron doesn't meet the trial criteria. And Biogen has an ironclad policy of refusing the med for so-called "compassionate use."
Biogen's reasoning is rooted in Tysabri's complex biography. As you all know, the drug was hailed as a major breakthrough for multiple sclerosis patients after its first launch, but then was pulled off the market in February 2005 because of links to a potentially fatal brain infection, PML. The drug was reintroduced in 2006 under a restrictive access program. Since then, Tysabri has won a broader market, with an approval to treat Crohn's disease. It's also seen a couple of new cases of PML in Europe; those cases were added to Tysabri's labeling.
Biogen CEO Jim Mullen has held up under the assault of publicity ginned up on Baron's behalf. Calls from the likes of Armstrong, Ted Kennedy, the Clintons, John Kerry and Henry Waxman haven't swayed him. The company doesn't want to set a precedent by allowing Baron to use Tysabri, given the PML risks--and the risk to Tysabri's future should Baron experience an adverse reaction. "We want to protect access for patients who are on the drug now and rely on it," a Biogen spokeswoman told Pharmalot. "We feel like we can't make an exception in this case."
Monday, February 4, 2008
Tysabari Approved for Crohn's Disease
Tysabri Approved for Crohn's Disease
TUESDAY, Jan. 15 (HealthDay News) --
Tysabri (natalizumab) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe Crohn's disease in people who haven't responded to other therapies.
Tysabri, made by the Ireland-based drugmaker Elan and Massachusetts-based Biogen Idec, was approved in 2006 to treat relapsing multiple sclerosis.
The drug has a boxed warning of increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection affecting the brain that could cause severe disability or death, the FDA said in a statement. Anaphylactic reactions and liver injury also have been reported in some users.
Crohn's patients prescribed the drug will be enrolled in a restricted distribution program called Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD-TOUCH). Under the program, physicians must evaluate Crohn's patients using Tysabri after three months and should discontinue use of the drug if there is no improvement, the FDA said.
Crohn's is an incurable bowel disease with symptoms that may include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestines, cramping, and abdominal pain. The disease, affecting more than 1 million people worldwide, can also lead to abnormal connections called fistulas from the intestines to the skin or internal organs.
More about Tysarbi:
Elan Corp., Ireland's biggest drugmaker, and partner Biogen Idec Inc. won U.S. approval for the use of their multiple sclerosis medicine Tysabri as a treatment for Crohn's disease.
The Food and Drug Administration issued its determination in an e-mailed statement today. Elan and Biogen said in a separate statement that they expect Tysabri to be available to Crohn's patients by the end of February, once an FDA-approved plan to minimize risks of the drug is in place.
The companies are trying to expand the use of the medicine, which brought in $93 million in the third quarter. Tysabri is taken by about 21,000 MS patients under prescribing restrictions because of a risk of rare, fatal brain infections. Similar rules will be used in treating Crohn's disease, a chronic inflammation of the intestines that affects about 1 million people worldwide.
The approval is ``an important step in the armamentarium for treatment but one that carries extreme risks,'' said Joyce Korvick, deputy director of the FDA's office of new gastroenterology drugs, on a conference call with reporters.
Other therapies for Crohn's include Abbott Laboratories' anti-inflammatory medicine Humira, which exceeded $3 billion in global sales for the first time in 2007, Abbott Chief Financial Officer Thomas Freyman said on Jan. 7.
Dublin-based Elan discovered Tysabri, and is developing the medicine as a Crohn's treatment. Its partner Biogen, based in Cambridge, Massachusetts, lost more than $5 billion in market value in December after announcing it failed to find a buyer and planned to remain independent.
Biogen rose 90 cents, or 1.5 percent, to $59.92 at 4 p.m. New York time in Nasdaq Stock Market composite trading. Elan's American depositary receipts, each equal to one ordinary share, rose 10 cents, or less than one percent, to $24.86.
Pulled From Market
Tysabri was the best hope in a decade for MS patients when it was approved in November 2004. It was pulled from the market three months later because of links to a neurological disorder called progressive multifocal leukoencephalopathy, or PML. Three patients contracted the disease, and two died.
About 14,000 patients have been treated with Tysabri since it was returned to the market as a multiple sclerosis drug in July 2006. No cases of PML have been reported. An advisory panel to the FDA voted 12-3 last July to recommend approval of the added use for Tysabri for Crohn's disease, with restrictions to reduce the risk of infection.
In October, the FDA extended its review. A month later, European regulators rejected an appeal by Elan and Biogen of an earlier decision that the product not be approved and marketed for Crohn's.
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