Celera Genomics Initiates Phase I Clinical Trial for Cathepsin S Inhibitor for the Treatment of Psoriasis.

ROCKVILLE, Md. -- Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced the initiation of Phase I clinical testing for its cathepsin S inhibitor, CRA-028129, for the treatment of psoriasis. In the Phase I trial, healthy volunteers will be randomized to receive orally-administered CRA-028129 or placebo. The dose amount and number of days of dosing will be escalated in sequential cohorts of study subjects in order to characterize the pharmacokinetic and maximum pharmacodynamic effects of CRA-028129. Approximately 70 subjects will be enrolled in this study.

This is a single center study being conducted at the Christchurch Clinical Studies Trust (CSST) in Christchurch, New Zealand. The initiation of this study follows approval from the New Zealand Director General of Health on the recommendation of the Standing Committee on Therapeutic Trials (SCOTT). SCOTT is a committee of the Health Research Council of New Zealand (HRC) which is convened to assess the scientific validity of applications for clinical trials. The study has also been approved by an HRC accredited ethics committee.

"The regulatory and ethical standards required in New Zealand fully meet or exceed the International Conference for Harmonisation (ICH) and United States Food and Drug Administration guidelines for Phase I trials," said James Yee, M.D., Ph.D., Vice-President and Head of Development of Celera Genomics. "The quality of clinical science and operations at CCST, and its proven performance in adhering to Good Clinical Practices assures that results from this healthy volunteer study will be considered a valid basis to judge the suitability of CRA-028129 for future international Phase II clinical development."

"We're pleased with the progress we've made in advancing our cathepsin S inhibitor through to this clinical development stage as a potential new treatment for psoriasis. Through our preclinical research we have identified two biomarkers of cathepsin S inhibition that we will use during our clinical trials as indicators of the pharmacodynamic behavior of this compound," said Robert Booth, Ph.D., Chief Scientific Officer of Celera Genomics. "Current treatments for psoriasis fail to induce permanent remissions, have the risk of unwanted adverse effects and/or are inconvenient to administer. CRA-028129's novel mechanism of action with the potential as an oral therapeutic provides an opportunity to improve on one or more of these unmet medical needs. Additionally, we believe that inhibition of cathepsin S could provide benefit in a number of other autoimmune diseases."

Celera Genomics has designed and synthesized extremely potent and selective compounds which demonstrate picomolar inhibitory potency against the cathepsin S enzyme and which also show inhibitory activity in cell systems in the nanomolar range. Celera Genomics has a number of additional cathepsin S inhibitors from different chemical templates. These are proceeding through preclinical evaluation.

"With today's accomplishment, coupled with the recent initiation of a Phase I study of our novel histone deacetylase (HDAC) inhibitor in cancer, we're pleased to have two unpartnered compounds currently undergoing clinical trials," said Kathy Ordonez, President of Celera Genomics. "As we have previously announced, we are seeking partners to assist us in capitalizing on our small molecule capability and pipeline which, as evidenced by these developments, continues to advance."

About Psoriasis and Cathepsin S

Psoriasis is a chronic, relapsing disease that has been diagnosed in 4.5 million adults in the United States, and is estimated to affect 1-3 percent of the population worldwide. Between 2 to 3 million of these patients have the moderate or severe form of the disease costing an approximate $1 billion each year. The most common form, plaque psoriasis, accounting for approximately 85% of all cases, appears as raised, red patches or lesions covered with a silvery white buildup of dead skin cells, called scale. There are between 150,000 and 260,000 cases of psoriasis that are diagnosed each year.

There is considerable evidence that the immune system is involved in the pathogenesis of psoriasis (1)(2). Cathepsin S is a cysteine protease which is expressed in certain antigen presenting cells and has been implicated in the presentation of antigens to CD4+ T cells. Inhibition of cathepsin S may reduce antigen presentation within certain antigen presenting cells and may therefore have a beneficial effect in the treatment of psoriasis.

CRA-028129 was discovered and developed by Celera Genomics as part of a proprietary non-partnered program to develop inhibitors of cathepsin S.

About Celera Genomics and Applera Corporation

Applera Corporation consists of two operating groups. The Celera Genomics Group is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics 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 (NYSE:ABI) 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 2004. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. 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. Information about Celera Genomics is available at www.celera.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," "expect," "intend," 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 Corporation 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 risks and uncertainties include but are not limited to: (1) Celera Genomics' unproven ability to discover, develop, or commercialize proprietary therapeutic products; (2) the risk that clinical trials of products that Celera Genomics 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 Genomics' 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) uncertainty of the availability to Celera Genomics of intellectual property protection, limitations on its ability to protect trade secrets, and the risk to it of infringement claims; and (5) other factors that might be described from time to time in Applera Corporation'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, Celera Discovery System, and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.

(1) Ghoreschi K & Rocken M (2004). Immune Deviation Strategies in the Therapy of Psoriasis. Current Drug Targets - Inflammation & Allergy, 3(2): 193-198.

(2) Gottlieb AB & Bos JD (2002). Recombinantly engineered human proteins: Transforming the treatment of psoriasis, Clinical Immunology 105: 105-116.