CVGR Covalent

Covalent Group, Inc. (Nasdaq: CVGR) announced today the signing of $1.3 million in new contracts with two different biopharmaceutical companies to assist in the development of their FDA New Drug Applications (NDA) for innovative investigational drugs for the treatment of cardiovascular disease. Both contracts provide for consulting services as well as assistance in the organization and writing of the Clinical Sections of their respective NDAs. Covalent Group will recognize revenues on a proportional performance basis over the life of the contract as services are performed. Kenneth M. Borow, M.D., Chief Executive Officer and President for Covalent Group, commented, "The first NDA contract included in today's announcement is in support of a drug whose use will be based on a pharmacogenomically tailored approach to the treatment of patients with chronic heart failure. This NDA is well aligned with the recent FDA guidance that supports pharmacogenomics as one of the major opportunities on the critical path to new medical products. If approved by the FDA, this drug would be the world's first pharmacogenomically targeted cardiovascular agent. Recent advances in pharmacogenomics make it possible to target therapies to sub-groups of patients most likely to respond with the hope that drug interventions might one day be tailor-made for individuals and adapted to each person's genetic makeup. The resulting improvement in efficacy augments the therapeutic benefits of the drug while decreasing side effects and potentially diminishing overall healthcare costs. Drugs targeting functionally important common and structurally subtle genetic differences have proven successful in other disease settings such as oncology and the time has come for this approach to be applied to cardiovascular disease. We are delighted to have been chosen by this new client to make important contributions to the regulatory filing of their lead product." Dr. Borow continued, "The second NDA contract is in support of a first-in-class drug with blockbuster potential that is designed to treat atherosclerosis and its most devastating consequence, coronary heart disease. Covalent is very proud that this sponsor has entrusted us with a high level of responsibility for the premier product in its drug development pipeline. In the past, Covalent has provided multiple drug development services to this company including operational support for clinical trials as well as design, execution, and evaluation of thorough QT interval studies. This new contract extends our relationship with the company and showcases our ability to integrate consulting, operational, and medical writing services into a single package in support of a major regulatory submission." Dr. Borow concluded, "Both of these NDA contracts demonstrate the depth of our therapeutic area expertise and the confidence that the biopharmaceutical industry has in our ability to support the entire spectrum of drug development. We are particularly interested in the opportunities associated with pharmacogenomics and personalized medicine. The NDA contract for pharmacogenomic targeting in patients with heart failure is an important step in that direction. We believe that our extensive consulting, clinical operations, and medical writing capabilities, our long history of programmatic successes, and our unique understanding of the issues and challenges facing the biopharmaceutical industry will provide a very valuable platform for these efforts." About Covalent Group, Inc. Covalent Group, Inc. is a clinical research organization that is a leader in the design and management of complex clinical trials and Patient Disease Registries for the pharmaceutical, biotechnology and medical device industries. The Company's mission is to provide its clients with high quality, full-service support for their biopharmaceutical development programs. Covalent offers therapeutic expertise, experienced team management and advanced technologies. The Company has drug and biologics development as well as clinical trial experience across a wide variety of therapeutic areas such as cardiovascular, endocrinology/metabolism, diabetes, vaccines, infectious diseases, gene therapy, immunology, neurology, oncology, gastroenterology, dermatology, hepatology, women's health and respiratory medicine. Covalent believes that its leadership in the design of complex clinical trials, its therapeutic expertise and commitment to excellence, and its application of innovative technologies, offer its clients a means to more quickly and cost effectively move products through the clinical development process. With its wholly-owned international subsidiary, Covalent Group, Ltd., Covalent is able to meet the North American and Western European drug development needs of its clients. For more information, please visit www.covalentgroup.com. This press release contains forward-looking statements identified by words such as "estimate," "project," "expect," "intend," "believe," "anticipate" and similar expressions. Actual results might differ materially from those projected in, expressed in or implied by the forward-looking statements. Potential risks and uncertainties that could affect the Company's future operating results and financial condition include, without limitation: (i) our success in attracting new business and retaining existing clients and projects; (ii) the size, duration, and timing of clinical trials we are currently managing may change unexpectedly; (iii) the termination, delay or cancellation of clinical trials we are currently managing could cause revenues to decline unexpectedly; (iv) the timing difference between our receipt of contract milestone or scheduled payments and our incurring costs to manage these trials; (v) outsourcing trends in the pharmaceutical, biotechnology and medical device industries; (vi) the ability to maintain profit margins in a competitive marketplace; (vii) our ability to attract and retain qualified personnel; (viii) the sensitivity of our business to general economic conditions; (ix) other economic, competitive, governmental and technological factors affecting our operations, markets, products, services and prices; (x) announced awards received from existing and potential customers are not definitive until fully negotiated contracts are executed by the parties;(xi) our backlog may not be indicative of future revenues and may not generate the revenues expected;(xii) our ability to successfully integrate the businesses of Covalent and Remedium and (xiii) the performance of the combined business to operate successfully and generate growth. You should not place any undue reliance on these forward looking statements which speak only as of the date of this press release. Additional information concerning factors that might affect our business or stock price which could cause actual results to materially differ from those in forward-looking statements is contained in Covalent Group's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2004 and other periodic reports under the Securities Exchange Act of 1934, as amended, copies of which are available upon request from Covalent Group's investor relations department or The Equity Group Inc.