Alzheimer's Club

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]