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   Biotech / MedicalElan Corporation, plc (ELN)


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To: sim1 who wrote (10257)3/25/2010 10:18:39 AM
From: D.Lu
   of 10345
 
A large study. Given the risks of TYSABRI, I wonder if they will have trouble enrolling subjects.

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To: D.Lu who wrote (10258)3/26/2010 8:57:18 AM
From: IRWIN JAMES FRANKEL
4 Recommendations   of 10345
 
Hi D Lu,

I do not think it will be hard to enroll. My wife was a Copaxone failure. Ifn antibodies degrading the utility of the other class of drug is just a matter of time and the higher the dose the shorter the time to resistance. It will take a long time to run the trial and get meaningful results. I wrote the rest of this post for IH, hope is of interest:

Switching study - Copaxone to Tysabri

My wife (who has RRMS) was on Copaxone for many years and did fairly well on it - that is until she had two serious exacerbations within one year. Her doctor pronounced the situation a treatment failure and suggested she shift to Tysabri. She has now been on T for over 2 years without any apparent exacerbation.

I told the story of her progress in a series of posts that can be accessed here:

Message 25078797

(By moving to the prior posts you can read the account.)

From my wife's experience and what I hear about others who have moved to T after being treatment failures, this "switching" study will support the case for moving to T when other treatments fail. Unfortunately, it will take years for meaningful data.

ij

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From: Arthur Radley4/5/2010 7:27:37 PM
   of 10345
 
knol.google.com

A very interesting blog on the Elan drug.....'appears' the author has a background in the biotech arena.........'appears'!

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From: Arthur Radley4/12/2010 2:03:53 PM
1 Recommendation   of 10345
 
Wells Fargo Initiates Coverage on Elan Corporation (ELN) with a Market Perform
7:20 am ET 04/12/2010 - StreetInsider
Wells Fargo initiates coverage on Elan Corporation, plc (NYSE: ELN) with a Market Perform. Wells analyst says, "Elan's growth and subsequently, price action, are coupled to Tysabri performance for the foreseeable future, in our opinion. Deciphering the future outlook for Tysabri is complex and impacted by many factors including its saftey profile and competitive landscape. We expect shares to trade in-line with the market until clarity in these areas are obtained." To see all the upgrades/downgrades on shares of ELN, visit our Analyst Ratings page. Elan Corporation, plc (Elan) is a neuroscience-based biotechnology company. Elan s operations are organized into two business units: BioNeurology (formerly Biopharmaceuticals) and Elan Drug Technologies (EDT).

Apparently WF has put a little wind in the sails for ELAN, as the volume has spiked today.

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From: sim14/13/2010 5:12:46 AM
2 Recommendations   of 10345
 
Large Body of Data on TYSABRI® to Be Presented at Annual Meeting of the American Academy of Neurology

– Data suggests improvement across broad range of functional and quality of life measures –

businesswire

*
Companies:
o Biogen Idec Inc.
o Elan Corp. plc

Press Release Source: Biogen Idec and Elan Corporation, plc On Tuesday April 13, 2010, 2:30 am EDT

TORONTO--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) today announced 15 company-sponsored platform and poster presentations at the American Academy of Neurology’s (AAN) 62nd Annual Meeting in Toronto, April 10 – 17, 2010. The AAN Annual Meeting is the world’s largest gathering of neurologists. The presented data, based on post-hoc analyses and patient-reported outcomes studies, highlights the ability of TYSABRI (natalizumab), in some multiple sclerosis (MS) patients, to improve sustained visual function, disability, overall quality of life (QoL), cognition and fatigue.

“TYSABRI continues to change the way neurologists and patients define success in the treatment of MS,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. “The data presented at AAN contribute to the growing body of scientific evidence supporting TYSABRI’s strong efficacy profile.”

Multiple sclerosis is one of the most common neurological disorders, affecting more than 400,000 people in the United States each year. Physical disabilities such as the loss of vision and difficulty walking are among the common symptoms associated with the disease and can have a devastating impact on quality of life for many MS patients. TYSABRI’s strong efficacy profile in treating MS demonstrated in clinical trials continues to be enhanced further with data such as those being presented at AAN.

Data from the 15 company-sponsored presentations at the conference show that TYSABRI, in some patients, improves sustained visual function, disability, overall QoL, cognition and fatigue. The presentations also include results from two studies related to the JC virus (JCV) and a follow-up study in pregnant women.

TYSABRI associated with sustained visual function improvement

Results of a post-hoc analysis of Phase III AFFIRM data demonstrated that TYSABRI is associated with sustained visual function improvement in some patients with MS. Vision impairment is one of the first symptoms experienced by many people with MS and can have a significant impact on daily life.

“Visual problems are often the first symptom of MS, and for many patients, the knowledge that vision may be compromised adds a level of anxiety about future quality of life and activities of daily living,” said Steven L. Galetta, M.D., University of Pennsylvania School of Medicine and an author on the study. “Fortunately, we have the suggestion from this study that natalizumab treatment may be associated with sustained improvement in visual function in some patients.”

In this post-hoc analysis, investigators examined whether TYSABRI caused improvement in visual function, as well as the capacity of low-contrast letter acuity (LCA), gray letters against a white background, and high-contrast letter acuity (HCA), standard black-on-white vision testing, to detect treatment-related improvement in visual function.

Visual improvement was measured by the number of letters a patient identified correctly at each visit. Cumulative probability of visual function improvement sustained over 12 weeks was determined for increases in score by seven letters, as well as by five letters and 10 letters.

Results showed that visual improvement, defined as =7-letter score increase from baseline, sustained for 12 weeks, was greater for TYSABRI (n=627) vs. placebo (n=314). This result was observed for LCA, where improvement in visual function at the 2.5 percent and 1.25 percent contrast levels was 57 percent (21.1% vs. 13.4%; HR=1.6, p=0.012) and 39 percent (31.6% vs. 23.9%; HR=1.4, p=0.014, Cox proportional hazards models), respectively. There were no significant differences between the treatment groups at the five-letter and 10-letter thresholds or the HCA.

The poster, Low-Contrast Letter Acuity Detects Visual Function Improvement in Phase 3 Relapsing MS Trials of Natalizumab (P05.060), will be available for viewing on April 15 from 7:30 a.m. - 12 p.m. EDT.

Dr. Galetta serves as a paid consultant for Biogen Idec.

Sustained improvement in physical function, as measured on the EDSS scale, was associated with improved quality of life for patients with relapsing MS taking TYSABRI

This study evaluated the relationship between sustained changes in disability, as measured by the Expanded Disability Status Scale (EDSS), and changes in patient-reported quality of life in TYSABRI patients. Disability improvement may be associated with improvements in patient-reported outcomes.

This analysis showed that sustained improvement in physician-rated EDSS scores was associated with sustained improvement in patient-reported QoL, including physical and mental components of QoL (as measured by Physical Component Summary, PCS, [p<0.0001] and Mental Component Summary, MCS, [p=0.0250] scores) and overall well-being (as measured by Visual Analogue Scale, VAS, [p<0.0001]). The association between sustained improvement in physician-measured EDSS and patient-reported measures of QoL suggests that EDSS is a meaningful outcome for assessing the impact of MS therapies on patients.

The poster, Improvement in EDSS Corresponds with Improvement in Quality of Life in Patients with Multiple Sclerosis (P02.169), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT.

MS patients report improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI

In this ongoing one-year longitudinal study, patients with MS were asked to assess their outcomes using validated patient-reported outcome measures prior to treatment initiation and after the third, sixth and 12th infusions with TYSABRI. The posters presented at AAN show that patients reported significant improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI.

One of the posters on this study, Effect of Natalizumab on Disease-Specific Quality of Life after One Year of Natalizumab Treatment (P02.164), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. Another titled Improvement in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab in the United States (P02.166) will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. A third titled Improvement in Patient-Reported Fatigue and Cognitive Function over Time with Natalizumab Treatment (P06.167) will be available for viewing on April 15 from 3 - 7:30 p.m. EDT.

AAN platform presentation shows MS patients treated with TYSABRI experienced no substantial changes in the presence of JCV DNA, and second platform shows that patients who developed progressive multifocal leukoencephalopathy (PML) had evidence of antibodies to JCV that suggests prior infection

One platform presents data suggesting that treatment with TYSABRI does not have a substantial effect on the presence of JCV DNA in MS patients. In the Dose Suspension Safety Assessment (n=1397) and STRATA (n=1094), JCV DNA was detected in less than 1 percent of all patients, approximately 50 percent of whom were TYSABRI naïve.

The second platform presents data indicating that patients who developed PML had evidence of prior infection with JCV, as measured by the presence of anti-JCV antibodies. Investigators evaluated serum samples from TYSABRI patients who developed PML where blood samples had been collected at least one year prior to the diagnosis of PML. Most of these samples were collected prior to beginning treatment with TYSABRI. In all of these patients, serum samples were positive for JCV antibodies prior to onset of PML, suggesting pre-existing JCV infection in these patients. Additional analyses are needed to determine whether anti-JCV antibodies are useful in stratifying for PML risk.

The first platform presentation, Effects of Natalizumab Treatment on the Presence of JC Virus DNA in Blood or Urine in Multiple Sclerosis Patients (S31.002), is on April 14 during the session from 4:15 - 5:30 p.m. EDT, and the second, Evaluation of the Incidence of Anti-JCV Antibodies in a Cohort of Natalizumab-Treated MS Patients (S31.003), is on April 14 during the session from 4:15 - 5:30 p.m. EDT.

Preliminary pregnancy outcomes among women exposed to TYSABRI

The TYSABRI Pregnancy Exposure Registry (TPER) is an observational, exposure-registration, follow-up study of pregnant women with MS or Crohn’s disease who were exposed to TYSABRI within three months prior to conception or at any time during pregnancy. The study is being conducted in the United States, Canada and the rest of the world. Information on TYSABRI exposure, potential confounding factors and pregnancy outcomes is being collected. Enrollment in the TPER is ongoing.

The poster, Preliminary Evaluation of Pregnancy Outcomes from the TYSABRI® (Natalizumab) Pregnancy Exposure Registry (P01.185), will be available for viewing on April 13 from 7:30 a.m. - 12 p.m. EDT.

About TYSABRI

TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.

Data from the Phase III AFFIRM trial highlights TYSABRI’s powerful efficacy. According to that data, which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001). In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures, compared to seven percent of placebo-treated patients.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares are listed on the New York and Irish Stock Exchanges. For additional information about the company, please visit elan.com.

Contact:

MEDIA CONTACTS:
Biogen Idec
Kate Weiss, 617-914-6524
or
Elan Corporation, plc
Mary Stutts, 650-794-4403
or
Miriam Mason, 650-877-7616
or
INVESTOR CONTACTS:
Biogen Idec
John Applegate, 617-679-2812
or
Kia Khaleghpour, 617-679-2812
or
Elan Corporation, plc
Chris Burns, + 353 1 709 4444 or 800-252-3526
or
David Marshall, +353 1 709 4444

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To: sim1 who wrote (10262)4/20/2010 4:07:34 PM
From: Arthur Radley
   of 10345
 
fool.com

Agree....two parts will be better than one, but sure don't want the hassle if they don't list the shares here in the US.

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From: Arthur Radley5/5/2010 8:03:43 PM
   of 10345
 
Anyone considering buying at this level......should they split the company, one would have to think that the two would be worth more than the current price............one would think! I hope!

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From: Arthur Radley5/10/2010 1:37:27 PM
   of 10345
 
finance.yahoo.com

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To: Arthur Radley who wrote (10265)5/10/2010 7:09:17 PM
From: steve kammerer
   of 10345
 
I didn't notice a $900 million infusion of cash into Elan from J & J.

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To: steve kammerer who wrote (10266)5/10/2010 7:55:06 PM
From: Arthur Radley
   of 10345
 
It happened last year--
This adds a little color to the deal, but they did have to go back and make a few revision because of BIIB position with ELN..

forbes.com

Personally.......drug is a long shot but a buy out could result if trials go well.

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