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Celera Genomics and Specialty Laboratories Announce Licensing Agreement for Commercialization of Cirrhosis Testing; Genetic Testing Could Be a Better Predictor for High Risk HCV Infected Individuals Than Current Clinical Factors

Posted on: Thursday, 22 June 2006, 09:00 CDT

Celera Genomics (NYSE:CRA), an Applera Corporation business, and Specialty Laboratories today announced that they have signed an agreement granting Specialty a non-exclusive license to Celera's risk markers for cirrhosis. The license agreement allows Specialty to select from among Celera's genetic findings to develop and commercialize a genetic test that predicts risk of progression to liver cirrhosis in individuals infected with hepatitis C virus (HCV).

Specialty intends to develop a constellation of single nucleotide polymorphisms (SNPs) based on Celera's findings that predict risk of cirrhosis in patients with chronic HCV that are believed to be more useful than present clinical risk factors in managing the disease. The use of a combination of SNPs as a prognostic tool suggests information may be applicable to a larger number of HCV-infected individuals, may prove more robust across risk groups tested, and may have more compelling use for patient management than current methodologies.

Under the terms of the agreement, Specialty will pay Celera an undisclosed upfront license fee upon successful validation of Specialty's test, and royalties on net sales for Specialty's commercial use of the test in the United States. Further financial details were not disclosed.

"The collaboration with Celera strategically complements our innovative and extensive pipeline of diagnostic services and reinforces our strong commitment to liver and gastrointestinal diseases," said James Peter, M.D., Ph.D., Founder and Chairman Emeritus of Specialty. "We believe the molecular diagnostics market is growing, particularly for innovative testing services such as those derived from Celera's genetic markers. Currently, there is an unmet medical need for a predictive method to determine which patients with chronic HCV are likely to develop fibrosis and progression to cirrhosis."

"We are pleased to have reached this agreement with an innovative and leading service provider in the molecular diagnostics industry," said Kathy Ordonez, President of Celera. "Specialty has a track record of introducing new testing services that change the paradigm for medicine, making them an outstanding partner for us. Specialty shares in our belief that our cirrhosis risk markers could lead to testing that could have a beneficial affect on hundreds of thousands of patients with chronic HCV infection, and we are committed to maximizing the success of Specialty in commercializing results from our genetics discovery."

About Celera's Cirrhosis SNPs

The SNPs that are associated with cirrhosis were identified and confirmed through multiple research studies conducted over three years involving approximately 1,500 individuals infected with chronic hepatitis C. Samples were tested for the presence of approximately 25,000 SNPs as part of a Celera functional genome scan. SNPs identified as associated with risk for cirrhosis through initial research disease association studies that survived replication by studying these SNPs with additional research samples, were used to develop a training algorithm to select the optimal constellation of SNPs. These SNPs were finally studied in another set of research samples to confirm their performance in predicting risk for cirrhosis.

Celera is currently pursuing this program independently, outside its strategic alliance with Abbott.

About Cirrhosis and Hepatitis C infection

Hepatitis C virus is a serious medical problem in the United States and throughout the world. Almost four million Americans are infected with the hepatitis C virus, of which 2.7 million have chronic infection. If undetected and untreated, hepatitis C infections can lead to chronic liver disease, including liver fibrosis, leading to cirrhosis and liver cancer. Hepatitis C infections are the second leading cause of liver cirrhosis and the leading indication for liver transplantation in the United States.(1)

Projections based on the current prevalence of infection and anticipated rates of progression raise concerns over the potential impact of HCV during the next two decades. A computer cohort simulation of the US population for 2010-2019 suggests that the morbidity and mortality associated with chronic hepatitis C will increase dramatically, resulting in 165,900 deaths from chronic liver disease, 27,200 deaths from hepatocellular carcinoma (HCC), and $10.7 billion in direct medical expenditures related to HCV(2).

For more information on the management of Hepatitis C patients, see for example http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm#H

Celera Analyst and Investor Day Information

Celera will host its Analyst and Investor Day meeting today. At the meeting, Celera's senior management will discuss the strategy for the business following the integration of Celera Diagnostics into Celera Genomics and update the investment community on the status of key products and development programs, as well as today's announcement. Celera management will also present its strategy for growth across all parts of the business, and as part of this presentation, management will provide its financial and business outlook for the business for fiscal 2007.

The meeting will be webcast and will begin at 9:00 a.m. Eastern Time. Interested parties may access the live webcast and replay by visiting the Investors & Media section of either the Celera Genomics website at www.celera.com or the Applera website at www.applera.com. It is suggested that participants access the webcast 15 minutes before the start of the live broadcast. The webcast replay will be archived until September 22, 2006 on the Presentations page of the Investors & Media section of each website.

About Celera Genomics and Applera Corporation

Applera Corporation consists of two operating groups. The Celera Genomics Group uses proprietary genomics and proteomics discovery platforms to develop molecular diagnostic products and to identify and validate novel drug targets. Celera maintains a strategic alliance in molecular diagnostics with Abbott. In addition, Celera is developing new molecular diagnostic and pharmacogenomic assays outside of its alliance with Abbott. Therapeutic antibodies against Celera-discovered drug targets are being advanced through strategic partnerships. 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 and develop new pharmaceuticals. Applied Biosystems' products also serve the needs of some markets outside of life science research, which we refer to as "applied markets," such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. 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 http://www.applera.com, or by telephoning 800.762.6923. Information about Celera Genomics is available at http://www.celera.com.

About Specialty Laboratories

Specialty Laboratories supports local pathology and community-based medicine by partnering with pathologists and hospitals to improve patient care and reduce episodes-of-care costs. Specialty offers hospitals an extensive menu of highly advanced clinical tests used by physicians to diagnose, monitor and treat disease and a single-source solution for esoteric testing needs. Specialty's web address is www.specialtylabs.com. Specialty is a wholly owned subsidiary of AmeriPath, Inc.

About Ameripath, Inc.

AmeriPath, a leading national provider of physician-based anatomic pathology, dermatopathology and molecular diagnostic services to physicians, hospitals, clinical laboratories and surgery centers, supports community-based medicine by helping physicians provide excellent and effective care for their patients. AmeriPath's team of more than 400 highly trained, board-certified pathologists and Ph.D. level scientists provide medical diagnostics services in outpatient laboratories owned, operated and managed by AmeriPath, as well as in hospitals and ambulatory surgical centers. AmeriPath's Web address is www.ameripath.com.

Forward-Looking Statements

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,""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) Celera's unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) the risk that clinical trials of products that Celera does discover and develop will not proceed as anticipated or may not be successful, or that such products will not receive required regulatory clearances or approvals; (3) the uncertainty that Celera's products will be accepted and adopted by the market, including the risk that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (4) legal, ethical, and social issues which could affect demand for Celera's products; and (5) 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.

(1) http://www.cdc.gov/

(2) AGA Technical review on the management of Hepatitis C (2006). Gastroenterology. 130: 231-264.

Copyright(C) 2006. Applera Corporation. All rights reserved. Applied Biosystems and Celera are registered trademarks and Applera and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.

Source: Business Wire

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