CVGR Covalent

Contract Valued at $1.2 million WAYNE, Pa., and GAITHERSBURG, Md., Dec. 5 /PRNewswire-FirstCall/ -- Covalent Group, Inc. (NASDAQ:CVGR) and Emergent BioSolutions Inc., today jointly announced the signing of a contract under which Covalent will provide Emergent BioSolutions with operational support in the development of an anthrax immune globulin (AIG) product for the treatment of anthrax infection. Under the contract Covalent will support Emergent BioSolutions' AIG development program by providing project management, study site management, field operations, data management, biostatistical services, and medical writing services. The AIG product being developed by Emergent is anticipated to be an intravenous formulation with high titers of antibodies to protect against anthrax infection. Immune globulins are being used increasingly in the treatment of diseases mediated by circulating toxins (e.g. tetanus, botulism) and specific infections (e.g. hepatitis B, cytomegalovirus, Staphylococcus aureus). Emergent BioSolutions has been collecting plasma containing high titer levels of anthrax antibodies over the past year from donors who have been vaccinated with BioThrax(R), the only FDA-licensed anthrax vaccine. BioThrax(R) is manufactured by BioPort Corporation, a wholly owned subsidiary of Emergent BioSolutions. "This agreement represents a significant step in our effort to bring an effective anthrax treatment to market," stated Dr. Steven Chatfield, Chief Scientific Officer of Emergent BioSolutions. "The resources being provided by Covalent are intended to facilitate a near term expansion of our program and provide us with a unique opportunity to leverage our own supply chain and build a large scale production base." Kenneth M. Borow, M.D., Covalent Group's President and Chief Executive Officer, commented, "We believe that the development of an immune globulin for the treatment of circulating anthrax toxins is an important addition to the battle against global terror. This is particularly relevant considering that the 2001 anthrax terrorist attacks resulted in the death of five innocent people whose lives may have been saved if an immune globulin had been readily available as treatment. The current contract represents Covalent's fourth counter-bioterrorism development program. Previous contracts have been in support of Phase 1 trials for vaccines dealing with biological approaches to countering the effects of plague, botulinum neurotoxin, and Venezuelan equine encephalitis." Dr. Borow continued, "Covalent has extensive expertise and experience in the development of biologics for the prevention/treatment of disease. For example, we recently made important operational and consulting contributions to Merck's Phase III Shingles (Herpes Zoster) Prevention Study which involved more than 38,500 subjects. The results of this landmark megatrial were published as the lead article in the New England Journal of Medicine on June 2nd 2005. I believe that Covalent's successful track record with the development of biological products will be the basis for continued expansion of this therapeutic area as an important contributor to our future financial success." About Anthrax Anthrax disease is an infection caused by the spore forming Bacillus anthracis. Anthrax is considered a likely biological warfare agent because of its ability to infect via the respiratory route, the high mortality of inhalational anthrax, and its use as a bioterror agent in 2001. The US Department of Health and Human Services (HHS) has taken action to stockpile anthrax vaccine (BioThrax(R)) and antimicrobials to fend against and combat future attacks. Since any delay in antimicrobial therapy and/or an overwhelming exposure of anthrax may result in toxemia and increased mortality rates, it is important to have additional treatments for actual cases of inhalation anthrax. As a result, the HHS is evaluating the use of immune globulins directed at anthrax as a treatment for toxemia resulting from inhalation anthrax infection. About Emergent BioSolutions Emergent BioSolutions Inc., is dedicated to the research, development and manufacture of novel products which harness the immune system to treat and prevent disease. These include products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction. The company currently employs more than 400 people with facilities in Gaithersburg and Frederick, Maryland, Lansing, Michigan, Berkshire, U.K. and Munich Germany. More information about Emergent BioSolutions and its subsidiaries can be found at http://www.ebsi.com/. 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, womens' 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., as well as its Strategic Partners operating in various regions around the world, Covalent is able to meet the global drug development needs of its clients. For more information, please visit http://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; and (xi) our backlog may not be indicative of future revenues and may not generate the revenues expected. 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. Investor Relations Contact for Covalent Lawrence Hoffman, CPA, Esq. CFO, Covalent Group, Inc. (610) 975-9533 Media Contact for Emergent BioSolutions: Kim Brennen Root (517) 749-3265 DATASOURCE: Covalent Group, Inc. CONTACT: Investor Relations: Lawrence Hoffman, CPA, Esq., CFO of Covalent Group, Inc., +1-610-975-9533, Media: Kim Brennen Root for Emergent BioSolutions, +1-517-749-3265 Web site: http://www.covalentgroup.com/ http://www.ebsi.com/

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