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Thanks NBB. Now all I am left with are LEAPS and some stocks. I hope FDA surpise us by approving the drug before 90 days.
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UPDATE 1-US FDA says Tysabri review a high priority
From Reuters.com
WASHINGTON, March 24 (Reuters) - A review of Biogen Idec (BIIB.O: Quote, Profile, Research) and Elan's (ELN.I: Quote, Profile, Research) bid to return multiple sclerosis drug Tysabri to the market "continues to be a high priority," the Food and Drug Administration said on Friday.
The FDA had delayed a decision for 90 days, the companies said on Wednesday.
The agency said on Friday it had extended the review because Biogen submitted a new plan to manage serious side effects from the drug.
"This application continues to be a high priority. The agency is working intensively to complete review of this new information and will attempt to do so before the end of the 90-day extension period," an FDA statement said.
Tysabri was pulled abruptly last year after three patients developed a life-threatening brain infection and two of them died. Earlier this month, a panel of FDA advisers voted unanimously to recommend the drug return to the market.Comment
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New Data on TYSABRI @American Academy of Neurology meeting
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Press Release Source: Biogen Idec and Elan Corporation, plc
New Data on TYSABRI(R) Demonstrate Significant Effects on Health-Related Quality of Life Measures in Patients with Multiple Sclerosis
Thursday April 6, 7:45 pm ET
Data presented at American Academy of Neurology Annual Meeting also Show Impact on Measures of Visual Function and Disability Progression
SAN DIEGO--(BUSINESS WIRE)--April 6, 2006--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that in Phase III multiple sclerosis (MS) studies TYSABRI® (natalizumab) showed significant effects on pre-specified health-related quality of life (QoL) measures, in addition to those previously reported on disability progression, relapse rate and MRI. Data presented this week at the annual meeting of the American Academy of Neurology in San Diego, CA also showed a significant impact on additional pre-specified measures of disability progression, including visual and cognitive function.
"MS is a debilitating disease that significantly reduces the quality of patients' lives by causing symptoms like fatigue, pain, and diminished emotional well-being. We have never before observed positive findings on our quality of life measures in a Phase III MS study. The TYSABRI study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, who presented the QoL findings at the AAN meeting.
TYSABRI Shows Improvement in Quality of Life Assessments
In the two Phase III TYSABRI clinical trials, AFFIRM and SENTINEL, QoL was assessed using three different measures, the Multiple Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey (SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS). The MSQLI is an MS-specific battery of 10 scales that measure disease impact on QoL including, fatigue, pain, sexual function, bowel and bladder function, visual impairment, mental health and need for social support. SF-36 is comprised of 36 questions designed to assess patients' physical and mental well-being. General well-being was also measured using the VAS.
In the AFFIRM monotherapy study, patients in the TYSABRI-treated group realized a significant improvement in physical measures of the SF-36 compared with a decline in the placebo-treated group (p=0.003). A significant improvement was also seen in the mental component of the SF-36 in patients treated with TYSABRI compared with a decline in the placebo-group (p=0.011). Significant benefits were also seen using the VAS (p=0.007). Improvements on quality of life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a).
TYSABRI Impacts Measures of Visual Function
In another analysis of the AFFIRM and SENTINEL data, patients treated with TYSABRI had a reduction in the risk of visual decline as measured by contrast testing compared to control. Loss of visual function is one of the most common causes of disability and lower QoL in MS patients. Low contrast letter acuity was a pre-specified endpoint in both studies. Recent studies have demonstrated that low contrast letter acuity (perception of light gray letters of progressively smaller size on a white background) is a more sensitive measure of visual dysfunction in MS than traditional measures.
TYSABRI Impacts Measures of Disability Progression
The primary efficacy endpoint of AFFIRM and SENTINEL at two years was the rate of disability progression sustained for three months as measured by the Expanded Disability Status Scale (EDSS). Additional measures of disability included the Multiple Sclerosis Functional Composite (MSFC), which consists of three tests that evaluate ambulation, upper extremity dexterity and cognitive function.
In AFFIRM, treatment with TYSABRI led to a 42% reduction in the risk of disability progression compared to placebo (p=0.0002). TYSABRI was also associated with significant delay in progressing to EDSS of 4.0 (ambulatory with moderate disability) and 6.0 (requiring a cane, crutch or brace). TYSABRI treatment also had a significant impact on all subscales of the MSFC, including the Paced Auditory Serial Addition Test (PASAT), a measure of cognitive function (p=0.005).
TYSABRI Phase III Safety
Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system has been reported in patients receiving TYSABRI. PML occurred in two MS patients who had received TYSABRI with AVONEX and in one Crohn's disease patient who had recently received an immunosuppressant. In placebo-controlled trials of
TYSABRI in MS, the incidence and rate of other serious infections were balanced between TYSABRI-treated patients and controls. Serious infections reported in TYSABRI-treated patients included pneumonia, urinary tract infection and appendicitis. The overall incidence and rate of common infections were also balanced between treatment groups. Commonly reported infections included upper respiratory tract infections, influenza, urinary tract infections, and gastroenteritis. Herpes infections were slightly more common in patients treated with TYSABRI. The incidence and rate of other serious and common adverse events in clinical trials were similarly balanced between treatment groups. Serious events that occurred in TYSABRI-treated patients included hypersensitivity reactions, including systemic reactions, depression, and cholelithiasis. Common adverse events reported include infusion reactions, headache, fatigue, and arthralgia.
Biogen Idec and Elan had previously voluntarily suspended TYSABRI from the U.S. market and dosing in all ongoing clinical trials based on reports of PML. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.
On March 8, 2006, the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend reintroduction of TYSABRI as a treatment for relapsing forms of MS. The companies anticipate action by the Agency regarding the reintroduction for TYSABRI in the U.S. on or before June 28, 2006. The companies' application for approval of TYSABRI as a treatment for MS is also under review with the European Medicines Agency.
On March 29, 2006, the companies announced they have enrolled and dosed the first patients in the TYSABRI monotherapy safety extension study program in MS. Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-center study. Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients.Comment
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sooner or later we will get paid for this wonderful drug .........
Earnings Preview:Biogen Idec
Monday April 24, 2:34 pm ET
Biogen Idec First-Quarter Earnings Tied to Avonex, Rituxan Sales
NEW YORK (AP) -- Biogen Idec Inc. reports earnings for the fiscal first quarter on Wednesday. The following is a summary of key developments and analyst opinion related to the period.
OVERVIEW: In early March, a Food and Drug Administration advisory panel recommended that the agency let Biogen and partner Elan Corp. resume sales of multiple sclerosis drug Tysabri, however the agency delayed making a final decision until June on the drug, which was pulled from the market because of a link to an often-fatal brain infection. At the end of March, Genentech and Biogen Idec Inc. applied to get cancer drug Rituxan approved as part of a first-line treatment regimen for a certain type of non-Hodgkin's lymphoma.
EXPECTATIONS: Analysts polled by Thomson Financial expect the company to earn 46 cents per share on revenue of $635.8 million.
ANALYST TAKE: Prudential analyst Ron Ellis, who rates Biogen "Overweight," raised his earnings estimate to 48 cents from 46 cents on revenue of about $427 million, driven by sales of multiple sclerosis drug Avonex and Rituxan. However, Baird analyst Christopher Raymond, who rates Biogen "Neutral," estimates earnings per share of 49 cents without substantial growth in Avonex sales.
WHATS AHEAD: The delay for the Tysabri re-release depends on the FDA's evaluation of the company's risk management plan to monitor the drug. Raymond believes that instances of the brain infection will resurface regardless and may cause physicians to use the drug as a second-line treatment.
STOCK PERFORMANCE: Shares of Biogen rose 3 percent over the quarter to close at $47.10 on the Nasdaq March 31. The stock has traded between $33.18 and $50.72 over the past 52 weeks.Comment
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HELLO! Get a load of the volume on ELN!!! money money money money money
and it's MINE!!!AAHHAHAHAHHAHAHHHAHAH!"Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." GoetheComment
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whats the story...... just because Canadian stocks are doing better then us stocks today?Comment
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Hello Dena,
No I don't think its got anything to do with that. The volume is 400% above it's 22 day average and some huge blocks going through. I just think we're getting closer to announcement date and maybe someone who knows someone said something. But hey, don't quote me.
Gains are slipping now but hey, not to worry. They'll "make more.""Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." GoetheComment
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I see this stock at $20.00 by late summerComment
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Why so conservative, King? The announcement is due in June and I would expect a bit more than a $4 or so pop from that. If I really thought $20 was target, I'd take my money and go buy more gold.Originally posted by kingofthehill"Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." GoetheComment
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Spikey, ol buddy, ol pal!!! How are ya baby??? It's been a while.
(been more subdued lately myself as some hard times came my way personally, but things are starting to turn upwards now.)
Cyber hugs to you my friend."Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." GoetheComment
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Thanks Spike. As a matter of fact, when I finished posting and went upstairs, it occured to me that I should've asked you to say a prayer for me. Guess we're a bit kindred since you gave me exactly what I unspokenly needed and wanted.
Thanks again and I'm so very glad that you are doing well."Whatever you can do or dream you can , begin it. Boldness has genius,power and magic in it." GoetheComment
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Charles Schwab
Price Alert
For Monday, May 15, 2006 as of 3:41PM EDT
Alert Triggered for Elan Corp PLC:
ELN Reached a New 52 Week High at $16.87
ELN rose 6.1% to a new 52 week high of $16.87. During the last
52 weeks, ELN's price has ranged from $6.08 on June 2, 2005 to
today's high of $16.87.
Additionally, over the last 12 months, ELN has increased 131.18%
while its peers in the Pharmaceuticals industry decreased 7.72%.
Please note you will receive only one "New 52 Week High" alert
per day for Elan Corp PLC.Comment
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Nice to see it hold up on such a ugly day.....
GOOOOOOOOOOO ELNComment
Prayin' fer ya that it's all fixed up! I'z bin good thank ya. Blessed in fact. Certainly more than I deserve. Have a great weekend!
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