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1. snugpharma

   • September 9th, 2010
   • 12:35 pm
   • Link to this comment

   What is wrong with you Ed, here is the link to the CEO Letter, from the Elan website
   http://www.elan.com/images/Shareholder%20Letter_tcm10-27128.pdf

   Now, as to Sonderby & Co.

   Ib Sonderby sets up a website to malign Elan management, he has continued deliberately to spread misinformation and recycle issues that have been previously addressed. Jack Schuler & Co issue will come before a Board meeting on Wednesday 15th Sept, two days after the Irish High Court injunction. Now Jim, if you want to hitch your wagon to such sources, BNET will be the loser. Here’s my story of the ‘real’ Elan

   Elan - We’ve come a long way from 2002: The Facts Not the Fiction
   http://www.investorvillage.com/smbd.asp?mb=160&mn=431605&pt=msg&mid=9488303

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   I invite Jim Edwards and readers to take a listen to Ib Sonderby’s Conference Call introducing four proposed potential Elan Board of Directors. TV soap opera, charade, Message Board egos on a day out, ignorant of the company, ignorant of the science, misguided Elan investors who were taken in by the spin by Sonderby & Co with their endless attempts to malign the good business names of Elan management and certain members on the the Board of Directors. Sonderby & Co. set out deliberately, to spread misinformation and recycle issues that have been previously addressed by Elan. Have a listen to the conference call. Don’t those four names put forward by Sonderby just fill you with confidence. After listening to this bizarre event, I think, you will agree, like me, that this Sonderby patsy ride has run out of steam, simply because it was built upon rumor and innuendo……….snug

   http://www.saveelan.com/blog/index.php/for-shareholders/

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   Elan - We’ve come along way from 2002: The Facts Not the Fiction

   This is my opinion on the Alzheimer’s Disease advancements by Elan in 8 years, which has put us on a path tantalisingly close, of making a profound difference in the lives of millions of people afflicted by this devastating disease. Read how Elan scientists have made very exciting breakthroughs over the years. Be in no doubt, under the leadership of Kelly Martin, from 2003 when Elan was near bankruptcy, Kelly and his management team saved Elan from oing out of existence, did the right things, and in all that time, did not sacrifice Elan’s ‘unique talent’ in Alzheimer’s research, so continued investing in the R&D funding, which has brought us to where we are today, the leading AD research labs, bar none. I am looking forward, not looking back. I am proud of Elan, I am proud of Elan management, I invite you to read about The Facts not The Fiction………………snug

   INTRODUCTORY NOTE TO ELAN PRE 2002

   CNDR 2nd Annual Retreat: Systemic Immunotherapy for Alzheimer’s Disease

   7 December 2001. Ivan Lieberburg of Elan Corporation summarized evidence over the past 15 years supporting the role of amyloid as causal in the onset and/or progression of AD. A, a 42 amino acid long peptide derived the amyloid precursor protein (APP), is released from APP following and c-secretase cleavage, and both are aspartyl proteases that are targets for AD drug discovery, as discussed in subsequent presentations. Using the first transgenic mouse model of AD-like A amyloidosis that was reported in 1995, Elan scientists discovered that immunization of young PDAPP mice with human A peptides prevented the immunized mice from developing AD-like A amyloid neuropathology at six months of age and beyond throughout their life span, while similar immunization of one-year-old mice with substantial A amyloid neuropathology stabilized, prevented further A deposition, or even reversed this pathology with advancing age for six months. These results have been repeated and extended by several other groups, and Elan scientist have gone on to show that passive immunization with some, but not all anti-A antibodies yield similar therapeutic effects in these mice. Current thinking by Elan scientists is that the anti-A antibodies cross the blood-brain barrier into brain, bind to A fibrils in amyloid deposits and promote clearance of these plaques by brain microglia. Other groups have also shown that A immunized mice with evidence of A amyloid clearance learn more effectively than non-immunized transgenic mice. Elan scientists have conducted extensive toxicological testing of this immunotherapy in several mammalian species, and they have not detected evidence of toxicity, but studies in human AD and control subjects have not demonstrated any correlation between the presence or absence of anti-A antibodies or levels thereof with the disease state. However, Elan scientists have completed two phase 1 clinical trials of this immunotherapy in the USA and the UK, and they now have initiated a multisite phase 2 study in 375 mild to moderate AD patients.John Trojanowski

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   Human A Vaccine Snagged by CNS Inflammation
   23 January 2002. Elan Corporation announced last Thursday that it would temporarily suspend further drug administration in the clinical phase 2A trial of its therapeutic vaccine AN-1792…

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   No Time to Waste? Elan-Wyeth Vaccine to Enter Phase 3 Trial
   24 May 2007. Elan and Wyeth announced on 21 May that they are planning to initiate a U.S. phase 3 clinical trial of AAB-001…

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   Passive Vaccine: Better in People Without ApoE4 Gene?
   17 June 2008. Today, Elan and Wyeth announced preliminary results of one of their closely watched Phase 2 clinical trials of Bapineuzumab…

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   Research Brief: Elan/Wyeth Vaccine Back on Track
   25 June 2008. Clinical testing of ACC-001, Elans second-generation A vaccine, is back on track…

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   Chicago: Bapineuzumabs Phase 2Was the Data Better Than the Spin?
   11 August 2008. The story of how Elan/Wyeths antibody therapy fared at the ICAD is one of the stranger tales in AD drug development…

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   Drug News Brief: Bapineuzumap Trial Drops Highest Dose
   2 April 2009. Elan and Wyeth announced today that two ongoing Phase 3 clinical trials of Bapineuzumab will discontinue the highest planned dose of 2 mg/kg…

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   Paper Alert-cum-SfN: Bapineuzumab Published, More AN1792 Presented
   19 November 2009. Phase 2 clinical trial data for bapineuzumab, Elan/Wyeths humanized monoclonal antibody against amyloid-, were published…

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   Drug BriefAdverse Events Prompt Dose Drop in Elan Trial
   16 December 2009. It appears that Dublin-based Elan’s small molecule drug candidate ELND005 has run into some trouble…

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   Anti-A Oligomer Headed for Phase 3 Clinical Trial

   13 August 2010. Top-line data announced this week from a Phase 2 clinical trial of the amyloid- (A) oligomer blocking drug scyllo-inositol (aka AZD-103, or ELND005) have given Elan Corporation PLC and partner Transition Therapeutics Inc. reason to take the compound into Phase 3. Overall, the drug did not significantly improve cognition and function in participants with mild to moderate Alzheimer disease. It therefore missed its formal co-primary outcome. Even so, the companies press release states that AZD-103 had an effect on clinical endpoints in an exploratory analysis. This suggested to the company scientists that a subgroup of patients may have improved on the medication.

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   2010 Elan’s AD Pipeline & Janssen Alzheimer Immunotherapy Program (which Elan has roughly 25%

   Bapineuzumab Phase III Clinical Trials:
   1. Bapineuzumab in Patients With Mild to Moderate Alzheimer’s Disease (ApoE4 Carrier)
   Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

   2. Bapineuzumab in Patients With Mild to Moderate Alzheimer’s Disease (ApoE4 Non-Carrier)
   Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

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   Study Evaluating the Long-term Safety and Efficacy of Subcutaneous Bapineuzumab
   Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

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   Study Evaluating ACC-001 in Mild to Moderate Alzheimers Disease Subjects
   Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

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   Elan also has
   Beta Secretase Research
   Gamma Secretase Research
   Gamma Secretase Inhibitor (Elnd007) pre-clinical
   Gamma Secretase Inhibitor (Elnd006) Phase 1 (note, Elan has spent up to 8 years resolving the past problems with most competetitors Gamma Secretase Inhibitors, which cleave Notch which must be avoided. That is one of the reasons Lilly Semagacestat did not work and caused skin cancers. Elan spent 8 years and have resolved that promblem which means they do not cleave Notch.

   Remember that when you wonder why some compounds are slower than others moving up the pipeline. We are still at the stage of Frontiers when learning about the complexity of the disease pathology in Alzheimer’s Disease in vivo.

   Elan has for the last 20 years lead with the discovery on all fronts of AD research. Just look above to what we have now, and the possibilites within the next two years. When I say that there is virtually nothing that can compare to Elan’s AD totality of pipeline and Janssen Alzheimer Immunotherapy Program, I am speaking with conviction. Anyone doubt my credentials, read my messages over these years. When people complain that Elan has not produced any new drug in years, I accept it as coming from an ignorance of what we are dealing with, Alzheimer’s, a brain disease, which up until recent years were not able to study drug interaction within the brain with likes of PiB dye traces and PET scanners. One of the major stumbling blocks is the Blood Brain Barrier. Elan has had its setbacks, very costly as most investors would add, but you have to grasp the near unsurmountable dangers when you enter the brain space. There is no short cut in developing therapeutics for AD. Many have tried, big pharma coming in late when they were in Phase III trials, but they ‘all’ have failed. August 2010, Lly450139 Semagacestat Phase III (failed) : March 2010,Dimebon Phase III Connection study (failed) :
   June 2008, Myriad Genetics Flurizan Phasee III (failed)

   Now, let’s have a look at the competion in the Phase III space:

   A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild to Moderate Alzheimers Disease - GAMMAGARD
   http://www.clinicaltrials.gov/ct2/show/NCT00818662?term=ivig+alzheimer’s&rank=3

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   A Phase III Study Effect of LY2062430 on the Progression of Alzheimer’s Disease (EXPEDITION) Eli Lilly - SOLANEZUMAB
   LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient’s participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.

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   Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer’s Disease on Donepezil (CONCERT)
   http://www.clinicaltrials.gov/ct2/show/NCT00818662?term=ivig+alzheimer’s&rank=3
   The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer’s disease on Donepezil.

   (the 6 month Dimebon ‘Connection’ study failed earlier this years, the ‘Concert’ study is a 12 month study).

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   Thats the Phase III competition.

   Remember that ELND-005 was nominated by Elan and Transition Therapeutics to go into Phase III Clinical Trials. I expect that a big pharma will join up and take on the responsibility of bringing D5 into phase III , manufacturing , launch and promotion. I expect that D5 will target both Mild to Moderate AD and early AD. If D5 gets to market, the opportunities created from both these AD categories will be significant.

   So, nextime you go read all these negative postings about Elan, its Management, its Unquestionably best AD Research and Development labs in the world for the last 20 years, led by people like Dale Schenk, Ted Yednock, Dora Games, Peter Seubert etc. Don’t you tell me that R&D was cut from 2003 when Kelly Martin joined a near bankrupt Elan, and put it back together, never sacrificing R&D, and that’s why you have the groundbreaking developments that are in Phase IIIs IIs I and pre clinical. That’s why Dale has now devoted much of his time to the next ‘big’ challenge - Parkinson’s . While all this was going on over the years, we had the convulsions with TYSABRI. But because the drug was so efficacious, it came back to the market and is now a Billion dollar blockbuster, and hopefully with Ted Yednock, the inventor of TYSABRI, and now his JCv antibody test , may bring renewed interest from MS patients who may feel more comfortable going on TYSABRI knowing that they are JCv negative.

   The clock is ticking down fast to 2012 and the bapineuzumab Phase III results. In the existing trials, they are utilising the latest biomarkers, imaging , that will give bapineuzmab the best possible chance of a positive outcome. The Alzheimer’s community are screaming for a disease modifying therapy, even a symptomatic one that may slow down the disease. There is a looming AD epidemic. We, Elan investors and supporters, can be part of this revolution in bringing badly needed new therapies to this devastating disease. I urge you to get behind Kelly Martin, the management, Chairman Kyran McLoughlin and the Board of Directors. Let’s get away from all this tabloid misinformation, insinuations, character assassination, selfish use of others as cannon fodder.

   If you are an Elan investor, you must appreciate that this company is a BioNeurology company. It must rank near the top as a high risk investment, but it holds the potential to be a high risk reward. Some of us may hope to get the chance again for a high reward, and have the opportunity to take some off the table. At this time, I have attempted to share my knowledge about Elan, that it is a well run company, under Kelly Martin, he has done a great job to position the company going forward. Just look at that AD pipeline and collaborations. There’s no comparrison with any other company, and remember all our AD pipeline besides AIP is solely Elan’s. Elan has no debt obligations before 2013, and Elan expects to be in profit in 2011. What a way to go into 2012 and the Bapieuzumab Phase III results, and hopefully TYSABRI benefitting from a good uptake with the reassurance that the JCv antibody test should bring. Take the time to read the Alzheimer Association Press Release: ALZHEIMERS DISEASE TO COST UNITED STATES
   $20 TRILLION OVER NEXT 40 YEARS

   ………….snug
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   CONTACT:
   Toni Williams, 202.638.8666; toni.williams@alz.org
   Alzheimers Association media line, 312.335.4078
   ALZHEIMERS DISEASE TO COST UNITED STATES
   $20 TRILLION OVER NEXT 40 YEARS
   Washington, D.C., May 19, 2010 A new report from the Alzheimers Association, Changing the Trajectory of Alzheimers Disease: A National Imperative shows that in the absence of disease-modifying treatments, the cumulative costs of care for people with Alzheimers from 2010 to 2050 will exceed $20 trillion, in todays dollars. The report, which examines the current trajectory of Alzheimers based on a model developed by the Lewin Group for the Alzheimers Association, also shows that the number of Americans age 65 and older who have this condition will increase from the 5.1 million today to 13.5 million by mid-century.
   We know that Alzheimers disease is not just a little memory loss- it is a national crisis that grows worse by the day, said Harry Johns, President and CEO of the Alzheimers Association. Alzheimers not only poses a significant threat to millions of families, but also drives tremendous costs for government programs like Medicare and Medicaid.
   Total costs of care for individuals with Alzheimers disease by all payers will soar from $172 billion in 2010 to more than $1 trillion in 2050, with Medicare costs increasing more than 600 percent, from $88 billion today to $627 billion in 2050. During the same time period, Medicaid costs will soar 400 percent, from $34 billion to $178 billion. One factor driving the exploding costs by 2050 is that nearly half (48 percent) of the projected 13.5 million people with Alzheimers will be in the severe stage of the disease when more expensive, intensive around-the-clock care is often necessary.
   Changing the Current Trajectory
   The new report is not all bad news, however, as it shows that Medicare and Medicaid can achieve dramatic savings and lives could be significantly improved with even incremental treatment improvements. Based on the same Lewin Group model, the report explores two alternate scenarios: one in which a disease-modifying treatment could delay the onset of Alzheimers by five years, and another in which a hypothetical treatment could slow the progression of this condition.
   Today, there are no treatments that can prevent, delay, slow or stop the progression of Alzheimers disease, said Johns. While the ultimate goal is a treatment that can completely prevent or cure Alzheimers, we can now see that even modest improvements can have a huge impact.
   Impact of a Hypothetical Treatment Delaying Onset: A treatment breakthrough that delays the onset
   of Alzheimers by five years similar, perhaps, to the effect of anti-cholesterol drugs on preventing heart disease would result in an immediate and long-lasting reduction in the number of Americans with this condition and the cost of their care. A breakthrough that delays onset by five years and begins to show its effect in 2015 would decrease the total number of Americans age 65 and older with Alzheimers from 5.6 million to 4 million in 2020.
   -more-
   Assuming the breakthrough occurred in 2015:

   The number of people age 65 and older with Alzheimers would be reduced by 5.8 million in 2050 43% of the 13.5 million Americans who would have been expected to have the condition in that year would be free of the conditions.

   In 2050, the number of people in the severe stage would also be much smaller with the treatment breakthrough 3.5 million instead of the expected 6.5 million.

   Annual Medicare savings compared to current trends would be $33 billion in 2020 and climb to $283 billion by mid-century, while annual Medicaid savings would increase from $9 billion in 2020 to $79 billion in 2050.
   Impact of Hypothetical Treatment Slowing Progression: A treatment breakthrough that slowed disease progression much as we have managed to do with HIV/AIDS and several cancers would result in far fewer people with Alzheimers disease in 2050 in the severe stage when care demands and costs are greatest. Assuming the breakthrough occurred in 2015:

   In 2020, the number of people age 65 and older with Alzheimers disease in the severe stage would drop from 2.4 million to 1.1 million. In 2050, the number of people in the severe stage would decline from an expected 6.5 million to 1.2 million.

   Annual Medicare savings compared to current trends would be $20 billion in 2020 and jump to $118 billion in 2050, while Medicaid savings would be $14 billion in 2020 and $62 billion in 2050.
   Addressing the Chronic Underinvestment in Research
   Ultimately solving the Alzheimer crisis will mean addressing the chronic underinvestment in research. This forecast of a rapidly aging population and dramatic rise in the number of Alzheimer cases in the coming years should catapult the government into action.
   Given the magnitude and the impact of this disease, the governments response to this burgeoning crisis has been stunningly neglectful, said Johns. Alzheimers is an unfolding natural disaster. The federal government has sent a token response and has no plan. Immediate and substantial research investments are required to avoid an even more disastrous future for American families and already overwhelmed state and federal budgets, continued Johns. For the human effects and the countrys fiscal future, we must change the trajectory of the Alzheimer crisis.
   The impact of Alzheimers disease - both in terms of lives affected and costs of care is staggering. As government leaders contend with the best approaches to rein in Medicare and Medicaid costs, we know Alzheimers will place a massive strain on an already overburdened health care system, said Robert J. Egge, Vice President of Public Policy for the Alzheimers Association. This report highlights that while we strive for the ideal a treatment that completely prevents or cures Alzheimers disease even more modest, disease-modifying treatments would provide substantial benefits to families and contribute to the solvency of Medicare and Medicaid.
   The Association is working to enact critical legislation to address these issues. The National Alzheimers Project Act creates a National Alzheimers Project Office and an inter-agency Advisory Council responsible for developing a national plan to overcome the Alzheimer crisis. Drawing on the expertise residing in various government agencies as well as individuals living with the disease, caregivers, providers and other stakeholders, this office would provide strategic planning and coordination for the fight against Alzheimers across the federal government as a whole, touching on a broad array of issues from research to care to support.
   After the embargo lifts, the full text of the Alzheimers Associations Changing the Trajectory of Alzheimers Disease: A National Imperative can be viewed at http://www.alz.org/trajectory.
   Alzheimers Association
   The Alzheimer’s Association is the leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimers disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimers.
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