Alzheimer's Club

A molecule expressed by nerve cells may protect humans from developing Alzheimer's Disease (AD). In particular, it may reduce the risk of the formation of senile plaques in the brains of patients with AD, as researchers from the Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch (Germany) and their collaborators in Denmark, Australia, and the USA have been able to demonstrate. The findings by Dr. Olav M. Andersen, Professor Thomas Willnow (both from the MDC) and Dr. Anders Nykjær (University of Aarhus, Denmark) have been published online in PNAS* (doi:10.1073).

A hallmark of Alzheimer disease are protein plaques in the brain which accumulate over many years. They are derived from the amyloid precursor protein (APP) which for unknown reasons is chopped up into smaller fragments, including the amyloid beta peptide, which forms these dangerous plaques. The plaques destroy the patients' nerve cells and lead to dementia, impairing the patients memory, thinking, and behaviour. According to the National Institutes of Health (NIH) more than four million Americans suffer from AD, an incurable disease. The older one gets, the greater the risk of developing this disease. It is estimated that about half of the individuals over 85 years of age are affected.

Professor Willnow and his colleagues were able to demonstrate that the molecule, named sorLa (abb. sorting protein-related receptor), binds to APP in nerve cells and thus prevents its dissection into the amyloid beta peptide. They could also show that genetically modified mice which cannot produce sorLA have increased levels of amyloid beta peptides because APP is destructed at a much higher rate than in healthy animals.

The researchers also looked at the brains of patients who died from AD and compared them with subjects who had not suffered from this disease. Surprisingly, the nerve cells of the AD patients had not produced sorLA, but the nerve cells of the control group had done so. The researchers conclude that in individuals whose brains produce little or no sorLA, the uncontrolled production of amyloid beta peptides likely accelerates onset and progression of neurodegenerative processes, making sorLA an important risk factor for AD.

Ongoing research is directed towards identification of substances that could increase the production of sorLA in the brain of those people that produce insufficient amounts of the molecule. The researchers hope that in the future it will be possible to pharmacologically reduce the formation of these dangerous plaques in the brain by modulating sorLA levels.

*Neuronal sorting protein-rtelated receptor sorLA/LR11 regulates processingof the amyloid precursor protein. Olav M. Andersen*, Juliane Reiche*, Vanessa Schmidt*, Michael Gotthardt*, Robert Spoelgen*, Joachim Behlke*, Christine A. F. von Arnim?, Tilman Breiderhoff*, Pernille Jansen?, Xin Wu$, Kelly R. Bales§, Roberto Cappai, Colin L. Masters, Jørgen Gliemann?, Elliot J. Mufson?, Bradley T. Hyman?, Steven M. Paul§, Anders Nykjær?, and Thomas Willnow*,**

*Max Delbrueck Center for Molecular Medicine, 13125 Berlin-Buch, Germany; ?Massachusetts General Hospital, Charlestown, MA 02129; §Lilly Research Laboratories, Indianapolis, IN ooo; ?Department of Neurological Sciences, Rush University Medical Center, Chicago, IL ooo; ?Institute of Medical Biochemistry, University of Aarhus, DK-800, Denmark; and Mental Health Research Institute of Victoria, Parkville ooo, Australia

Press and Public Affairs: Max Delbrück Center for Molecular Medicine(MDC) Berlin-Buch
Barbara Bachtler Robert-Rössle-Str. 10 13125 Berlin bachtler@mdc-berlin.de , http://www.mdc-berlin.de

Source: idw-online.de (last viewed 12 September 2005) [FullText]

THE WOODLANDS, Texas (7 September 2005) - Power3 Medical Products, Inc. (OTC: PWRM.PK) announced today that it has filed a provisional patent application with the United States Patent and Trademark Office for the Company's blood-based Alzheimer's disease (AD) specific diagnostic test. The patent application is being filed in conjunction with major research institutions in the Houston area, with Power3 having an exclusive license to commercialize the technology involved. This application is one of 13 provisional patent applications, 9 utility patents pending, and 1 issued
patent, owned and/or licensed by Power3. The application is in support of the Company's planned third Pre-IDE application to be filed with the United States Food and Drug Administration (FDA) to seek their guidance on aspects of the approval process for the diagnostic tests being commercialized by the Company.

"The purpose of this blood serum test is to diagnose whether a patient has AD and distinguish that from geriatric patients who have no signs of dementia and from patients who have AD like symptoms but do not have AD," says Ira L. Goldknopf, Chief Scientific Officer of Power3 Medical. "The test is being developed for use by internists, psychiatrists, and general neurologists, and for AD specialists as well."

"Alzheimer's disease is difficult to diagnose, particularly in the early stages, because currently there are no objective blood serum tests available for the early diagnosis of AD," said Steven Rash, chairman and chief executive officer. "Our objective is to obtain patent protection for Power3's intellectual property rights used in this test, measuring changes among groups of biomarkers in blood serum. We believe that patent protection for the specific diagnosis of Alzheimer's disease will prove to be a strong asset in the Company's ever growing intellectual property portfolio, and thereby, serve to enhance shareholder value."

Power3's test comprises collecting a blood sample from a patient, separating the proteins present in the sample, analyzing a panel of protein biomarkers using proteomic techniques, and determining whether or not the patient has AD based on the quantity of the biomarkers in the patient's sample combined with biostatistical analysis. The Company also intends to extend the technology to high throughput immunodiagnostics suitable for clinical laboratories and doctors' offices.

The Power3 intellectual property portfolio includes other pending patents, provisional patent applications, and research and license agreements with leading medical research institutions in the areas of cancer, drug resistance, metabolic syndrome, and neurodegenerative disease.

About Power3 Medical Products

Power3 Medical Products, http://www.Power3Medical.com , is a leading proteomics company engaged in the discovery of protein footprints, pathways, and mechanisms of diseases. The Company's patent-pending technologies are being used to develop screening and diagnostic tests for the early detectionand treatment of disease. The Company's identified protein biomarkers, drug targets, and diagnostic tests are targeted toward markets with critical unmet needs in areas such as breast cancer and neurodegenerative disease. The Company operates a state-of-the-art proteomics laboratory in The Woodlands, Texas.

Contacts: Steven B. Rash, Chairman and CEO, Power3 Medical Products, Inc.

Source: Power3 Medical Products, Inc., http://www.power3medical.com PRNewswire Press Release (7 September 2005) [FullText]

"Could a simple word test be used to identify people who might be suffering from the very early stages of Alzheimer's disease? British scientists think so. Results of a study presented at a science conference on Tuesday revealed that people in the first stages of the incurable illness cannot write down as many animals and fruits in one-minute period as healthy individuals.

Professor Andy Ellis of the University of York in England also discovered that the characteristics of the words the Alzheimer's sufferers produced were different. They retained very familiar words, ones heard frequently and words learned in early, rather than late, childhood. "Just by looking at the characteristics of the words people produced you could correctly determine whether somebody came from the group of healthy controls or the Alzheimer's patients," he told the British Association science meeting.

Ellis and his colleagues believe the results of the study, involving 96 patients and 40 healthy controls with an average age of 77, could form the basis of a test to determine whether elderly patients are just having a "senior moment" or the memory lapse is more serious. "It is possible that exploring the characteristics of the words that are still available to them might be one of the ways one can begin to detect that something is going wrong," said Ellis. "There is considerable value in identifying people who are beginning to show the first signs and this might be one way of doing that."

DEMENTIA: Alzheimer's is the leading cause of dementia in the elderly and affects an estimated 12 million people around the globe. The incidence of the disease is expected to increase as the population ages. There is no cure for the progressive illness, which robs people of their memory and mental ability, but drug treatments may slow the early progression of the disorder. Animals listed in the written test by the healthy elderly people included giraffes, zebras and badgers -- creatures seldom seen on the Alzheimer's patient list. "They are animals whose names children tend to learn more at around the age of 6-10 rather than 1-5," he said, adding they are creatures less talked or heard about than cats or dogs.

Ellis said a test based on the findings may help to assist with the early diagnoses of the illness and allow people to receive treatment as soon as possible. "The next phase of the research is to look into the possibility of making a prognostic guide," Ellis added."

Source: Patricia Reaney. Word test may give clues to Alzheimer's disease. Reuters AlertNet (6 September 2005) [FullText]

NeuroTrax Corporation Establishes Board of Advisors Consisting of Leaders in Science and Business. Jeffrey L. Cummings of NIH accredited Alzheimer's Disease Center at UCLA to hold NeuroTrax Advisory Board Member Post

NEW YORK (7 September 2005) - NeuroTrax Corporation announced today the establishment of a board of industry experts. According to Ely Simon, CEO of NeuroTrax, "These opinion leaders represent decades of executive-level experience in our most critical focus areas. Especially notable is the rare combination of highly credible scientific credentials and business expertise among the Advisory Board members."

The NeuroTrax Board of Advisors is chaired by Howard Fillit, M.D., the founding Executive Director of the Institute for the Study of Aging, a biomedical venture philanthropy foundation advancing drug discovery for Alzheimer's disease. Dr. Fillit has over 25 years of experience in the Alzheimer's and cognitive aging field, and is currently clinical professor of geriatrics, medicine, and professor of neurobiology at The Mount Sinai School of Medicine. Jeffrey L. Cummings, M.D., a leading authority in the fields of aging and dementia, is author of the Neuropsychiatric Inventory. He is the founder and director of the UCLA Alzheimer's Disease Center and past president of the Behavioral Neurology Society and the American Neuropsychiatric Association. Dr. Cummings has authored over 400 peer-reviewed papers. Paula Tallal, Ph.D. is a founder of Scientific Learning Corporation (Nasdaq: SCIL) and a world-recognized authority on language-learning disabilities. A cognitive neuroscientist and a clinical psychologist, she is a founder of the Center for Molecular and Behavioral Neuroscience at Rutgers University. In 1996, Dr. Tallal co-founded the Scientific Learning Corporation, a neuroscience company dedicated to developing and delivering research-based, cognitive and educational programs, where she currently serves on the Board. Dan Dragalin, M.D. is Executive Vice President of Multiplan, Inc., where he has responsibility for development and maintenance of the MultiPlan PPO network, the largest in the US, comprised of 4,600 hospitals, 100,000 ancillary facilities and over 500,000 practitioners. Prior to joining MultiPlan, Dr. Dragalin held executive positions in One Health Plan, NY Life, HMO Blue, Towers Perrin, Prudential Insurance Company of America. Dr. Dragalin has served as the Health Insurance Association of America representative on the AMA's CPT-4 Editorial Panel, Board of Directors of the National Committee on Quality Assurance, and the Managed Care Task Force of the Joint Commission.

NeuroTrax Corporation developed Mindstreams(R), a sophisticated computerized assessment suite performed in the doctor's office to detect the early signs of Alzheimer's disease and cognitive impairment from neurological psychiatric disease and to track treatment effects.

For more information, call toll-free 888-208-8160 or visit http://www.neurotrax.com.

Source: NeuroTrax Corporation Web Site: http://www.neurotrax.com PRNewswire Press release (7 September 2005) [FullText]

Recipients to Focus on New Technologies That Cross the Blood-Brain Barrier and Target Specific Regions in the Brain

BURLINGAME, Calif. (7 Sept. 2005) - Accelerate Brain Cancer Cure (ABC2), the Alzheimer's Association®, The Michael J. Fox Foundation for Parkinson's Research, and The Robert Packard Center for ALS Research at Johns Hopkins today announced the selection of recipients of an awards program initiated this year by The Brain Trust, a pioneering collaboration that seeks development of new approaches to advance brain disease cures. The Brain Trust's program reviewed applications focused on technologies that can achieve selective targeting and/or delivery of therapeutic agents to specific regions or cells in the brain, including overcoming the limitations imposed by the blood-brain barrier.

Recipients of the 2005 Brain Trust awards are:

Scott Banta, Ph.D., Assistant Professor, Chemical Engineering, and Barclay Morrison III, Ph.D., Assistant Professor, Biomedical Engineering, both in the School of Engineering and Applied Science at Columbia University. Dr. Banta and Dr. Morrison's project -- "Directed evolution of cell penetrating peptides for therapeutic delivery across the blood-brain barrier to specific cellular targets" -- was selected by the awards committee because of its potential to enable delivery of therapies for a broad range of neuro-degenerative diseases

Ruben Boado, Ph.D., Vice President, Molecular Biology, of ArmaGen Technologies, Inc., for his project entitled -- "Genetic Engineering of a Recombinant Neuroprotective Neurotrophin that crosses the Blood-Brain Barrier." ArmaGen was founded by William Pardridge, M.D., to develop platform technology solutions for crossing the blood-brain barrier. These technologies have been shown to deliver small molecules, recombinant proteins and non-viral gene therapies to the brain. Dr. Pardridge is Professor of Medicine at UCLA and has a distinguished career in the blood-brain barrier area.

"We are pleased with the high quality of candidates for the 2005 Brain Trust awards and are excited to announce award recipients who we believe are pursuing unique programs with a broad range of applications and near-term potential," stated John Reher, ABC2 Executive Director. "The project at Columbia will certainly benefit from the university's leading position as a source of innovation in the neurosciences. Further, we think it is a distinct advantage that the ArmaGen team is solely focused on blood-brain barrier technologies because these are a key priority for research into new therapies for diseases of the brain."

In October 2004, ABC2 convened a meeting of the Alzheimer's Association, The Michael J. Fox Foundation, the Packard Center and others to identify common problems in the development of therapies for neuro-degenerative brain diseases. The group, named the Brain Trust, hopes to expand to include many other brain organizations, companies, and universities in funding other collaborative efforts.

About Accelerate Brain Cancer Cure

Accelerate Brain Cancer Cure (ABC2) was founded in May 2001 by Dan and Steve Case and their families, along with leading scientists and entrepreneurs. ABC2 aims to raise awareness about brain cancer and help mobilize critical scientific research through research grants and partnerships. ABC2 funds outstanding and novel translational science that is aimed at the discovery of a cure for brain cancer.

Each year more than 17,000 people in the United States find out that they have a malignant primary brain tumor. An additional 100,000 patients are diagnosed with a brain tumor that has metastasized from another part of the body. The mission of ABC2 is to accelerate a cure for brain cancer by increasing the number of potential therapies discovered and then rapidly moving them into the clinic to help patients. In order to accelerate progress in what has been an under-served field of research, ABC2 provides researchers from all backgrounds with the support they need to make critical breakthroughs in brain cancer research.

For more information, visit http://www.abc2.org/ or contact John Reher at 650/685-2200.

About Alzheimer's Association

Incorporated on April 10, 1980, the Alzheimer's Association® is the world leader in Alzheimer's research and support, and is the first and largest voluntary health organization dedicated to finding prevention methods, treatments and an eventual cure for Alzheimer's.

For 25 years, the donor-supported, not-for-profit Alzheimer's Association has provided reliable information and care consultation; created supportive services for families; increased funding for dementia research; and influenced public policy changes.

Their mission is to eliminate Alzheimer's disease through the advancement of research and to enhance care and support for individuals, their families and caregivers.

Their vision is a world without Alzheimer's disease.

For further information, visit http://www.alz.org/

About The Michael J. Fox Foundation for Parkinson's Research

The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda.

Enormous progress toward finding a cure has been made on many neurological fronts, and scientists' understanding of the brain and how disease affects it has increased dramatically. The Foundation seeks to hasten progress further by awarding grants that help guarantee that new and innovative research avenues are thoroughly funded and explored.

In 1998, actor Michael J. Fox publicly disclosed that seven years earlier, he had been diagnosed with Parkinson's disease, which affects approximately six million people worldwide. Two years later, he founded The Michael J. Fox Foundation for Parkinson's Research, dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda. To date, The Michael J. Fox Foundation for Parkinson's Research has funded more than $50 million in research, either directly or through partnerships with the Parkinson's community and other public and private funders.

For more information on The Michael J. Fox Foundation for Parkinson's Research, visit http://www.michaeljfox.org/ or call Joyce Oberdorf at 212/509-1650.

About The Robert Packard Center for ALS Research at Johns Hopkins

The Robert Packard Center for ALS Research at Johns Hopkins is the only research center of its kind dedicated solely to finding a cure for amyotrophic lateral sclerosis (ALS).

The Packard Center is the only grant-giving ALS research center that requires investigators to work together, a powerful and innovative arrangement. Fueled by this spirit of collaboration, more than 45 of the world's leading scientists from Hopkins, other universities, and biotech companies aggressively pursue effective treatments and ultimately a cure for ALS. Currently, more than 50% of their funded investigators are outside Johns Hopkins. This "virtual laboratory" ensures that the brightest scientific minds across the world receive funding, regardless of their locations.

Every month, these funded scientists hold brainstorming sessions to identify promising research approaches and to evaluate each other's progress. The Scientific Advisory Board evaluates investigators' work annually, to make sure they are on track.

The core of the model, and of the Center's mission, is to connect the best researchers and clinicians to collaboratively discover the cause of ALS and to rapidly translate that information into real therapeutics. They strongly believe that this new research model holds enormous promise in their efforts to find treatments and, eventually, a cure for ALS.

For further information visit http://www.alscenter.org/ or contact Rebecca Berger at 410/502-7677.

Source: Accelerate Brain Cancer Cure Press Release at PRNewswire. Yahoo! News (7 September 2005) [FullText]

Take steps to end Alzheimer's at the Northern Middlesex Memory Walk on Sunday, Sept. 25. The three-mile and 1.5-mile walks begin and end at Boarding House Park in Lowell. Registration starts at 8:30 a.m. Walk starts at 9:30 a.m. Live entertainment will be provided by Music by Dave.

Last year, for the first time, Memory Walk broke the $1 million mark in donations raised statewide by participants in 10 Walk locations throughout Massachusetts. This year, Memory Walk participants in Massachusetts have set a goal of $1,250,000 in pledges. All of the funds raised from Memory Walk stay in the community to fund research as well as provide care and support for individuals and families touched by Alzheimer's.

Some of the support programs funded by Memory Walk include:

Helpline - Each year, Helpline counselors who have been educated and trained in all aspects of Alzheimer's disease assist nearly 5,000 people in Massachusetts with Alzheimer's, their families and professional caregivers. Helpline is available 24/7.

Safe return - The Alzheimer's Association operates the emergency Safe Return program 24 hours a day in order to locate people with Alzheimer's who have wandered and become lost.

Support groups - Assisted more than 120 Alzheimer's patient and family support groups

Government involvement - Advocated at the local, state and federal level to ensure access to quality community and long term care.

Outreach programs - Coordinated outreach programs to underserved and multicultural populations.

Early stage patient programs - Offered both support groups and educational seminars to assist individuals in the early stages of memory loss to cope with and manage the disease.

Family education programs - Offered programs on research, the importance of diagnosis and treatment, legal issues, care planning, safety issues and more at numerous locations throughout the state.

More than 4.5 million Americans have Alzheimer's disease, including 140,000 right here in Massachusetts. These numbers will grow dramatically in the coming years as our population ages. Alzheimer's is a degenerative disease of the brain for which there is no known cure. It impairs the brain's ability to remember, reason and make judgments. [see FullText at www.Townonline.com]

Celera Diagnostics Extends Collaboration with Merck in Alzheimer's Disease; Research to Genetically Validate and Prioritize Novel Drug Targets for the Treatment of Alzheimer's Disease


ALAMEDA, Calif.--(BUSINESS WIRE)--Sept. 7, 2005--Celera Diagnostics, a joint venture between the Celera Genomics Group (NYSE:CRA) and Applied Biosystems Group (NYSE:ABI) of Applera Corporation, today announced the extension of its collaboration with Merck & Co., Inc. aimed at developing new treatments for Alzheimer's disease. Under this collaboration, Celera Diagnostics and Merck will combine their research efforts in the genetics of this devastating brain disease to genetically validate and prioritize a series of genes targeted for drug development. The primary goal of the collaboration is to accelerate the discovery of new drugs to address the unmet clinical need for the treatment of Alzheimer's. This collaboration follows the recent completion of the work between the two companies that was started in July 2004 pertaining to the identification of novel targets for drug discovery and diagnostic markers related to this disease.

Under the terms of this agreement, Celera Diagnostics will genotype selected gene-based mutations, or SNPs, in four independent case-control sample collections. Genotyping will include proprietary SNPs from the Applera-funded Applera Genome Initiative. The case-control sets will consist of DNA samples from patients with confirmed Alzheimer's, and age-, and gender-matched controls. The total number of individuals included in this study is estimated to be approximately 2,800, making it one of the largest discovery studies of its kind in understanding the disease. Additional terms of the agreement were not disclosed.

"We're pleased to extend our collaboration which combines our strengths in analyzing and understanding genetic variation associated with multiple common diseases with Merck's extensive knowledge of the biology underlying neurodegenerative diseases and its global leadership in the development of innovative therapeutics," said Thomas White, Ph.D., Chief Scientific Officer at Celera Diagnostics. "This target validation program is one example of the value we're able to provide our therapeutic partners worldwide; other examples include identifying individuals who may benefit most from early therapeutic treatment and predict those individuals who will best respond to new therapies."

Celera Diagnostics' disease association studies compare genotype and/or gene expression profiles in multiple large sample collections to identify genetic markers linked with disease risk, progression and response to therapy. Celera Diagnostics is currently conducting large-scale disease association studies for multiple complex conditions, including cardiovascular disease, breast cancer, auto-immune diseases, Alzheimer's disease, liver disease and diabetes. The company has discovered and replicated genetic markers in several disease areas, some of which have been presented at scientific meetings and published in peer-reviewed journals over the last year, others are in advanced stages of being reported. Celera Diagnostics published that it had identified genetic variants in the glyceraldehyde-3-phosphate dehydrogenase (GAPD) gene associated with late-onset Alzheimer's disease in the Proceedings of the National Academy of Sciences (Li et al., 2004) and in amyloid precursor protein binding protein B2 in Human Mutation (Li et al, 2005). These findings continue to be evaluated for potential pharmacogenomic implications for drugs in development, as well as for current therapies for Alzheimer's and other neurodegenerative diseases.

About Alzheimer's disease

Alzheimer's disease (AD), the most common form of dementia among the elderly, is a complex neurodegenerative disorder resulting from multiple genetic and nongenetic factors (Myers & Goate, 2001). As expected, advancing age is the most important known risk factor for AD. The disease usually begins after age 60, and the number of people with the disease doubles every 5 years beyond age 65 (Evans et al., 1989). About 5 percent of men and women ages 65 to 74 have AD, and nearly half of those age 85 and older may have the disease (Bird et al., 1989). While younger people also get AD, it is much less common.

Family history is another risk factor. Scientists believe that genetics may play a role in many AD cases. For example, familial AD, a rare form of AD that usually occurs between the ages of 30 and 60, is inherited. The more common form of AD is known as late-onset, and as the name suggests, it occurs later in life, and appears sporadic. However, several risk factor genes have been implicated to cause the disease. For example, a large body of evidence supports a central role for a-amyloid in AD etiology. The only well established genetic risk factor identified so far for late-onset AD is a gene that makes one form of a protein called apolipoprotein E (APOE). Mutations in GAPD described above (Li et al., 2004), and in amyloid precursor protein binding protein B2 (Li et al, 2005) have been shown to increase AD risk as well. Genetic modeling and whole genome linkage scans have implicated several genes in the genetics of sporadic AD, but the precise genes, which modulate the risk of AD, remain to be confirmed.

It is estimated that as many as 4.5 million Americans suffer from AD, and this number is expected to grow - by 2050 the number of individuals with AD could range from 11.3 million to 16 million (Herbert et al., 2003). National direct and indirect annual costs of caring for individuals with AD are at least $100 billion (Ernst & Hay, 1994). It is estimated that AD costs American business more than $61 billion a year, and of that figure, $24.6 billion covers Alzheimer health care and $36.5 billion covers costs related to caregivers of individuals with Alzheimer's, including lost productivity, absenteeism and worker replacement (Koppel, 2002).

About Celera Diagnostics and Applera Corporation

Celera Diagnostics is a 50/50 joint venture between two Applera Corporation businesses, Applied Biosystems and Celera Genomics. Headquartered in Alameda, CA, Celera Diagnostics focuses on developing new molecular and protein-based diagnostic tests to predict, characterize, monitor and select therapy for a variety of clinical conditions. The Celera Genomics Group, located in Rockville, MD, and South San Francisco, CA, is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of nearly $1.8 billion during fiscal 2005. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at www.applera.com, or by telephoning 800.762.6923.

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Celera Diagnostics; (2) uncertainty of market acceptance of the its, or its collaborators', products; and (3) other factors that might be described from time to time in Applera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Copyright(C) 2005. Applera Corporation. All Rights Reserved. Applied Biosystems, Celera, Celera Diagnostics and Celera Genomics are registered trademarks of Applera Corporation or its subsidiaries in the U.S. and certain other countries.


References

Hebert, LE; Scherr, PA; Bienias, JL; Bennett, DA; Evans, DA.
"Alzheimer Disease in the U.S. Population: Prevalence Estimates Using the 2000 Census." Archives of Neurology August 2003; 60 (8): 1119-1122.

Evans, DA; Funkenstein, HH; Albert, MS; et al. "Prevalence of Alzheimer's Disease in a Community Population of Older Persons: Higher than Previously Reported." JAMA 1989; 262(18): 2552 - 2556.

Bird, TD; Sumi, SM; Nemens, EJ; Nochlin, D; Schellenberg, G; et al. "Phenotypic Heterogeneity in Familial Alzheimer's Disease: A Study of 24 Kindreds." Annals of Neurology 1989; 25(1): 12 - 25.

Ernst, RL; Hay, JW. "The U.S. Economic and Social Costs of Alzheimer's Disease Revisited." American Journal of Public Health 1994; 84(8): 1261 - 1264. For the $100 billion annual cost, this study cites figures based on 1991 data, which were updated in the journal's press release to 1994 figures. Cited in 2001 - 2002 Alzheimer's Disease Progress Report. National Institutes of Health publication number 03-5333, July 2003; p. 2.

Koppel, R. Alzheimer's Disease: The Costs to U.S. Businesses in 2002. Washington, D.C.: Alzheimer's Association; 2002.

Li Y, Nowotny P, Holmans et al. "Association of late-onset Alzheimer's disease with genetic variation in multiple members of the GAPD gene family". Proceedings of the National Academy of Sciences USA 2004; 101: 15688-15693.

Li Y, Hollingworth P, Moore et al. "Genetic association of the APP binding protein 2 gene (APBB2) with late onset Alzheimer disease". Human Mutation 2005; 25: 270-277.

Myers, A. J. & Goate, A. M. (2001) Curr. Opin. Neurol. 14, 433-440.

Source: Press Release at BusinessWire (7 September 2005) [FullText]

"RIDGEFIELD PARK, N.J. (1 September 2005) -- Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO Haruo Naito) and Eisai Inc. (Headquarters: Teaneck, NJ, Chairman and CEO Hajime Shimizu) announced today that on their behalf, Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, MD) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for ARICEPT® (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD). ARICEPT, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, is currently approved for treatment of mild to moderate AD.

"Our goal to provide ARICEPT to people with severe Alzheimer's disease is consistent with Eisai's human health care mission to improve the lives of patients and their families," said Lonnel Coats, president and COO, Eisai Inc.

The August 31 submission is based on data from a six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial conducted in approximately 250 nursing home patients with severe AD. In the pivotal study, patients with severe AD (Mini Mental State Examination scores 1-10) treated with ARICEPT had a statistically significant improvement compared to those taking placebo on both primary measures of efficacy: the Severe Impairment Battery (SIB scale) and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS ADL severe scale). The SIB measures cognition in a more severe population. The ADCS ADL measures patient function and ability to conduct activities of daily living.

Treatment with ARICEPT® (donepezil HCl tablets) was generally well tolerated. The most common adverse events in ARICEPT-treated patients reported at more than twice the rate of placebo-treated patients were diarrhea and hallucinations. The rate of discontinuation for adverse events was greater in the ARICEPT-treated patients than in the placebo-treated patients (15.6 % vs 6.7%).

AD is a progressive brain disease that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. AD affects 4.5 million Americans. One in 10 persons over age 65 has AD, and nearly half of those over 85 have it. The levels of acetylcholine (ACh), a brain chemical involved in memory and thinking, decrease in people with AD. ARICEPT is believed to work by inhibiting the breakdown of ACh, thereby increasing available levels of this chemical in the brain.

Information About ARICEPT Treatment in Alzheimer's disease

While there is no cure for Alzheimer's disease, medical treatments are available to help manage symptoms of the disease. Once-a-day prescription ARICEPT is indicated for mild to moderate Alzheimer's disease.

In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.

ARICEPT is well tolerated but may not be for everyone. Some people may have nausea, diarrhea, not sleep well or vomit. Some people may have muscle cramps, feel very tired or may not want to eat. In studies, these side effects were usually mild and went away over time. People at risk for stomach ulcers or who take certain other medicines should tell their doctors, because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting.

ARICEPT is the number one prescribed Alzheimer's disease therapy worldwide, with more than 1 billion patient days of ARICEPT therapy. More than 1.7 million people in the United States alone have begun ARICEPT therapy.

ARICEPT® (donepezil HCl tablets) was discovered and developed and is manufactured and distributed by Eisai.

For more information about managing Alzheimer's disease and about ARICEPT, see accompanying full prescribing information or call (888) 999-9616 or visit www.aricept.com.

About Eisai Co., Ltd. Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 7,700 people worldwide.

About Eisai Medical Research Inc Eisai Medical Research Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Eisai Medical Research Inc. was established to focus solely on clinical research and to expedite clinical drug development of new chemical entities and of new indications for marketed products.

About Eisai Inc Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $2 billion in fiscal year 2004 (year ended March 31, 2005).

About Pfizer Inc Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best- known consumer brands."

Source: Eisai Submits Application to FDA for ARICEPT(R) for Treatment of Severe Alzheimer's Disease. Yahoo News (1 September 2005) [FullText]