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   Biotech / MedicalElan Corporation, plc (ELN)


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From: Arthur Radley1/26/2010 7:13:21 PM
   of 10345
 
finance.yahoo.com

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From: Arthur Radley2/5/2010 11:59:17 AM
   of 10345
 
FDA just announced new labeling requirements for Tysabri.........however, they emphasise that benefits of the drug outweigh the downside.

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To: Arthur Radley who wrote (10248)2/23/2010 10:35:15 AM
From: Harold Engstrom
1 Recommendation   of 10345
 
Elan now needs to begin emphasizing results. The company continues to see Tysabri revenues climb, but has seen EDT revenues drop (Tricor is now declining) and will lose $30m in quarterly Azactam revenue starting April 1st.

Expenses appear too high for a company that does not manufacture, market, sell or distribute. And R&D programs have been stuck in place for almost 6 years now, except for partnered programs (AAB and ELND-005.) Notably, the PD antibody that Lars Ekman said would enter P1 during 2004 has yet to do so, and the anti-VLA4 small molecules seem to have ceased development altogether.

The company had almost 1,700 employees prior to the JNJ agreement, with Kelly Martin insisting that the company could not move forward with fewer people or leaner structures. With 70% of its revenues coming from Biogen's sales of Tysabri, 10% of its sales coming from sales of Maxipime and Azactam which are supplied by GSK and distributed and sold by 3rd parties, and 20% of its sales coming from EDT royalties received from 3rd parties, AND with no R&D progress on programs managed by Elan, it is hard to understand how Elan needs so many employees and can spend so much money.

I think Elan can lean up and still push its dormant programs along. JNJ and Biogen are running the Alzheimers and Tysabri clinical programs respectively. Lilly is driving its gamma secretase program. ELND-005 is oral and the p2 is on autopilot at present. EDT should be a straightforward proposition to run.

Last year, the company promoted the idea that it put in place cost savings that would save $12.5m per quarter by Q4 of last year. But these did not manifest (the $30m per quarter that JNJ assumes in R&D spending did show up.) My question is: when will the BoD and shareholders insist on operating performance?

Elan appears to have the engine and the wheels to get it somewhere good and fast. But, it does seem to be missing a driver.

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To: Harold Engstrom who wrote (10249)2/23/2010 11:21:24 AM
From: Arthur Radley
   of 10345
 
Elan is my shoulda-coulda-wisha hadn't bought stock. I've just put it aside dreaming that one day I will see my upper teen entry price revisited.........one day! IMO, this is the perfect company for a takeover and shifting of priorities needed. Overhead is way out of line....IMO!

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To: Arthur Radley who wrote (10250)2/23/2010 11:39:16 AM
From: Harold Engstrom
   of 10345
 
Arthur, Elan is a study in how not to run a pharmaceutical company. It is one of the few companies that I have seen where it is the science that really and truly saves the company's bacon over and over. Usually, it is the scientists-turned-managers who dig holes for the company. In this case, it is "professional" management that seems to have dug hole after hole for Elan and then sell the assets the scientists have built to pay their way out of the self-inflicted jams.

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To: Harold Engstrom who wrote (10251)2/23/2010 11:54:55 AM
From: Arthur Radley
   of 10345
 
Nothing against the good Irish people, but they seem to promote executives to run their domiciled companies by the amount of beer they can consume, sitting in a pub. My former company was an international leader, taken over by an Irish 'hot shot' that within a year destroyed the company and just stiffed their bondholders to the tune of about $4B in what is now worthless holdings. His whole ploy was to skim off the top of any and all revenue........ sacking employees right and left.

As you state.....ELAN has some wonderful researchers........but decision making by the executives have placed a millstone around their neck.

I will wait........and hope!

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To: Arthur Radley who wrote (10252)2/23/2010 12:10:58 PM
From: tom pope
1 Recommendation   of 10345
 
The best example of that phenomenon was also one of the earliest - Tony O'Reilly of Heinz, more than 20 years ago.

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To: tom pope who wrote (10253)2/23/2010 12:24:11 PM
From: Arthur Radley
   of 10345
 
Ah! the sage words of Dr. Whitaker, attempting to bring reason to the game.....only to be shouted down. What difference does it make when everything is merely pieces of paper, with no underlying production to support the grand scheme?

cedarlounge.wordpress.com

Had forgotten this episode....but he goes down with my all-star.......the Chainsaw Al at Sunbeam.

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To: Arthur Radley who wrote (10252)2/23/2010 12:45:04 PM
From: Harold Engstrom
1 Recommendation   of 10345
 
I don't know much about Kelly Martin's personal habits. And, I don't think that his compensation has been excessive by the standards of his peers in finance. But, his decision-making has been extremely poor and his staff seems to consist of a large number of fellow ex-Merrill Lynch people who do not seem to make any difference to Elan's progress.

He seems to have spend maybe $200m towards manufacturing facilties that were never actually built. He hired and fired 2 sales forces. After 7 years at the helm of Elan during which time he could have negotiated top dollar and excellent terms for AAB, he instead waited until the last minute and essentially donated AAB control to JNJ for $0. Risk assessment has never been a part of Kelly Martin's belt of management 101 tools - a major flaw for a pharma exec. And cost control has been a must for Elan for several years, but notably absent (in my opinion.)

Fundamentally, Kelly Martin does not seem interested in running a biopharmaceutical business. He does seems interested in being a CEO. Elan needs someone who is interested in both things simultaneously.

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From: sim13/1/2010 6:47:50 AM
1 Recommendation   of 10345
 
Neuroimaging Technique Supports Reduction in Amyloid-Beta in Brains of Patients Suffering from Alzheimer's Disease Treated with Bapineuzumab

Phase II Study Published Online in Lancet Neurology

Press Release Source: Elan Corporation, plc On Sunday February 28, 2010, 7:00 pm EST

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that findings from a Phase II study which suggested bapineuzumab reduced amyloid-beta deposits in the brains of Alzheimer’s disease patients as measured using a neuroimaging technique known as [11C]PiB PET, were published in the February 28, 2010 online edition of Lancet Neurology. Bapineuzumab is a compound under development by Pfizer and Janssen Alzheimer Immunotherapy, a Johnson & Johnson subsidiary in which Elan holds a minority equity interest.

The findings of the study further suggest that it may be possible to assess and monitor the effects of potential therapeutic agents on amyloid-beta deposits in patients with Alzheimer’s disease using this neuroimaging technique.

Patients in the study were randomized to either bapineuzumab treatment or placebo groups. Estimated mean [11C]PiB retention ratio change from baseline to week 78 was -0.09 in the bapineuzumab group and +0.15 in the placebo group. The estimated mean difference in [11C]PiB retention ratio change from baseline to week 78 between the bapineuzumab group and the placebo group was -0.24. Differences between the bapineuzumab group and the placebo group in the individual regions of interest were similar to the overall mean difference.

“We are encouraged by the findings of this study,” said Dr. Menghis Bairu, Chief Medical Officer for Elan. “The potential to use [11C]PiB PET imaging to monitor the effectiveness of potential therapeutics on amyloid beta load during treatment could play a major role in Alzheimer’s research and future clinical trial designs.”

About the Study

The study, conducted in patients with mild to moderate Alzheimer’s disease was a Phase II multi-center, double-blind, placebo-controlled multiple ascending dose study. Twenty-eight patients were randomized to receive one of three dose levels of bapineuzumab in a 1-hour IV infusion every 13 weeks for up to 6 infusions (a total of 78 weeks) or placebo. Each patient underwent [11C]PiB PET, [18F] FDG PET, clinical assessments of cognition function, CSF sampling for amyloid-beta and tau, volumetric and safety MRIs, and safety evaluations. The study was powered to detect a treatment difference in [11C]PiB PET retention between bapineuzumab and placebo treated patients from baseline to study end. The study was not powered to evaluate efficacy on clinical or other biomarker outcomes. Adverse events were typically mild to moderate in severity and transient. Two patients in the 2.0mg/kg bapineuzumab group had transient cerebral vasogenic edema.

While the study was partially funded by Elan Pharmaceuticals in 2008, on September 17, 2009, Elan completed a definitive transaction with Johnson & Johnson whereby Johnson & Johnson acquired substantially all of the assets and rights of Elan related to the Alzheimer’s Immunotherapy Program (AIP), through a newly formed Johnson & Johnson subsidiary, Janssen Alzheimer Immunotherapy. In consideration for the transfer of its AIP rights and assets, Elan received a 49.9% equity interest in Janssen AI. The AIP clinical programs include bapineuzumab IV and Sub-cutaneous formulations, ACC-001 and backup compounds. All future updates regarding Elan’s interest in bapineuzumab and other compounds in the AIP will be provided by Janssen Alzheimer Immunotherapy.

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 trade on the New York and Irish Stock Exchanges. For additional information about the company, please visit elan.com.

Additional Information

To view the full article, please visit www.lancet.com

Safe Harbor/Forward-Looking Statements

The statements in this press release regarding the potential for the use of [11C] PiB PET imaging and the clinical program for bapinuezumab, are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that the clinical program for bapineuzumab will be successful in demonstrating safety and/or efficacy, that there will not be problems or delays in clinical development, or that bapineuzumab will ever receive regulatory approval or be successfully commercialized. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward looking statements include those detailed from time to time in Elan’s periodic reports with the Securities and Exchange Commission, including Elan’s Reports of Foreign Issuer on Form 6-K and Annual Report on Form 20-F, particularly the discussion under the caption “Item 3 D, Risk Factors” in Elan’s Annual Report on Form 20-F. For the year ended December 31, 2009, which was filed with the Securities and Exchange Commission on February 25, 2010. The forward-looking Statements in this press release are qualified by these risks. The companies assume no obligation to publicly update any forward looking statements, whether as a result of new information, future developments or otherwise.

Contact:

Elan Corporation, plc
MEDIA:
Mary Stutts, 650-794-4403
Niamh Lyons, 353 1 663 3602
or
INVESTORS:
Chris Burns, 800-252-3526
David Marshall, 353 1 709 4444

===============================================================

The Lancet Neurology, Early Online Publication, 1 March 2010
doi:10.1016/S1474-4422(10)70043-0Cite or Link Using DOI

11C-PiB PET assessment of change in fibrillar amyloid-ß load in patients with Alzheimer's disease treated with bapineuzumab: a phase 2, double-blind, placebo-controlled, ascending-dose study

Original Text

Juha O Rinne MD a Corresponding AuthorEmail Address, David J Brooks MD b, Martin N Rossor FRCP c, Nick C Fox FRCP c, Roger Bullock MRCPsych d, William E Klunk MD e, Chester A Mathis PhD e, Kaj Blennow MD f, Jerome Barakos MD g, Aren A Okello MRCP b, Sofia Rodriguez Martinez de LIano MD b, Enchi Liu PhD h, Martin Koller MD i, Keith M Gregg PhD h, Dale Schenk PhD i, Ronald Black MD j, Michael Grundman MD i

Summary

Background

Carbon-11-labelled Pittsburgh compound B (11C-PiB) PET is a marker of cortical fibrillar amyloid-ß load in vivo. We used 11C-PiB PET to investigate whether bapineuzumab, a humanised anti-amyloid-ß monoclonal antibody, would reduce cortical fibrillar amyloid-ß load in patients with Alzheimer's disease.

Methods

Patients with mild-to-moderate Alzheimer's disease were randomly assigned to receive intravenous bapineuzumab or placebo in a ratio of seven to three in three ascending dose groups (0·5, 1·0, or 2·0 mg/kg). Each dose group was enrolled after safety review of the previous group. Randomisation was by interactive voice response system; masking was achieved with numbered kit allocation. Patients, investigators, study site personnel, sponsor staff, and carers were masked to treatment. Patients received up to six infusions, 13 weeks apart, and had 11C-PiB PET scans at baseline and at weeks 20, 45, and 78. The primary outcome was the difference between the pooled bapineuzumab group and the pooled placebo group in mean change from screening to week 78 in 11C-PiB cortical to cerebellar retention ratio averaged across six cortical regions of interest. Analysis was by modified intention to treat. This study is registered with EudraCT, number 2004-004120-12; ISRCTN17517446.

Findings

28 patients were assigned to bapineuzumab (n=20) or placebo (n=8). 19 patients in the bapineuzumab group and seven in the placebo group were included in the modified intention-to-treat analysis. Estimated mean 11C-PiB retention ratio change from baseline to week 78 was -0·09 (95% CI -0·16 to -0·02; p=0·014) in the bapineuzumab group and 0·15 (95% CI 0·02 to 0·28; p=0·022) in the placebo group. Estimated mean difference in 11C-PiB retention ratio change from baseline to week 78 between the bapineuzumab group and the placebo group was -0·24 (95% CI -0·39 to -0·09; p=0·003). Differences between the bapineuzumab group and the placebo group in the individual regions of interest were similar to the overall mean difference. Adverse events were typically mild to moderate in severity and transient. Two patients in the 2·0 mg/kg bapineuzumab group had transient cerebral vasogenic oedema.

Interpretation

Treatment with bapineuzumab for 78 weeks reduced cortical 11C-PiB retention compared with both baseline and placebo. 11C-PiB PET seems to be useful in assessing the effects of potential Alzheimer's disease treatments on cortical fibrillar amyloid-ß load in vivo.

Funding
Elan Pharmaceuticals and Wyeth Research.

lancet.com

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