WAYNE, Pa., Jan. 8 /PRNewswire-FirstCall/ -- Covalent Group, Inc. today announced that it has signed a new contract with DynPort Vaccine Company LLC (DVC) for a Phase 1 study in the development of a recombinant vaccine designed to provide protection against botulinum neurotoxin. The $1.1 million contract value of this award was included in Covalent's new business announcement dated December 15, 2003.
Botulinum neurotoxins, known primarily for causing cases of food-borne botulism, are produced by the bacterium Clostridium botulinum and the related species Clostridium baratii and Clostridium butyricum. These bacteria produce seven distinct types of botulinum neurotoxins. Most cases of botulism occur when a person swallows a substance that contains the neurotoxin. The neurotoxin then passes through the gastrointestinal tract and into the blood until it eventually reaches peripheral nerve endings where it has the capability to paralyze muscles, including those needed to breathe. The ultimate result can be death.
Kenneth M. Borow, M.D., Covalent Group's President and Chief Executive Officer commented, "We are delighted to begin this relationship with DVC. In the post September 11, 2001 world, a vaccine against botulinum neurotoxins has become a priority as part of our nation's capabilities to fight worldwide terror. Winning this highly competitive bid represents an important step for Covalent Group. Our expertise in the regulatory requirements, conceptualization and design, and operational conduct of vaccine trials is a longstanding strength of our Company. Our vaccine capabilities nicely complement our extensive experience in the clinical development of biologics and gene therapy products. Pending the results of the current Phase 1 study, other clinical trials using this vaccine would be required as part of its overall development program. We look forward to the opportunity of working closely with DVC on this and other vaccine development programs in the future."
About DynPort Vaccine Company LLC
DynPort Vaccine Company LLC is a biopharmaceutical company dedicated to the development and licensure of safe and efficacious biodefense vaccines for the U.S. Department of Defense through the Joint Vaccine Acquisition Program (JVAP), and civilian populations. DVC is a joint venture between Computer Sciences Corporation , one of the world's leading information technology (IT) service companies, and Porton International, Inc., a leading vaccine development company focused on the development of biodefense vaccines. Founded in 1997, DVC employs 135 professionals at its headquarters in Frederick, MD. For more information about DVC visit http://www.dynport.com/.
About Covalent Group
Covalent Group is a clinical research organization that is a leader in the design and management of complex clinical trials 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 clinical trials. Covalent offers therapeutic expertise, experienced team management and advanced technologies. The Company has clinical trial experience across a wide variety of therapeutic areas such as vaccines, biologics, gene therapy, immunology, cardiovascular, endocrinology/metabolism, diabetes, neurology, oncology, infectious diseases, gastroenterology, dermatology, hepatology, womens' health and respiratory medicine. Covalent believes that its leadership in the design of complex clinical trials, its application of innovative technologies, therapeutic expertise and commitment to quality offer its clients a means to more quickly and cost effectively develop products through the clinical trial process. In addition, the Company's use of its proprietary TeleTrial(R) technology to support its drug development services creates consistency in the way it conducts clinical trials globally. With its wholly-owned international subsidiary, Covalent Group, Ltd., as well as its Strategic Partners based in Sydney, Australia and Moscow, Russia, Covalent is able to meet many of the global drug development needs of its clients.
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; (iii) the termination, delay or cancellation of clinical trials; (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; and (ix) other economic, competitive, governmental and technological factors affecting our operations, markets, products, services and prices. Additional information concerning factors that could cause actual results to materially differ from those in forward-looking statements is contained in Covalent Group's SEC filings, including its Registration Statement on Form S-3, Annual Report on Form 10-KSB 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.
Covalent Investor contact: Jill T. Meleski, (646) 536-7032 Covalent media contact: Gregory Q. Tiberend, (646) 536-7005 Contact Covalent on-line: http://www.covalentgroup.com/
Covalent Group, Inc.CONTACT: Investor - Jill T. Meleski, +1-646-536-7032, Media - Gregory Q.Tiberend, +1-646-536-7005, both of Covalent Group, Inc.
