DEERFIELD, Ill., May 4 /PRNewswire-FirstCall/ -- Baxter International Inc. today announced that it is collaborating with DVC LLC, a Computer Sciences Corporation Company, to develop cell-culture based influenza vaccines as part of a U.S. Government contract award to DVC.
Baxter will develop seasonal (or inter-pandemic) and pandemic vaccines using the company's vero-cell technology, which has the potential to significantly reduce production time compared to traditional vaccine production methods using embryonated hens' eggs. The development work to be performed by Baxter will support the licensure of a seasonal vaccine and the completion of clinical trials for a pandemic vaccine. DVC will manage the overall project as well as the clinical trials during the five-year development effort. If approved by the U.S. Food and Drug Administration, Baxter would hold the product licenses for these seasonal and pandemic influenza vaccines in the U.S. market.
Baxter will manufacture the candidate vaccines at the company's production facility in the Czech Republic. Under the terms of this agreement, a significant portion of the $40.97 million currently funded will go toward the development of the candidate pandemic vaccine and a seasonal influenza vaccine.
"We are very pleased that the U.S. Government has chosen DVC and Baxter to pursue this important program," said Joy Amundson, corporate vice president and president of Baxter's BioScience business. "The combination of Baxter's vaccines technology and manufacturing capabilities with DVC's experience with government vaccine programs establishes an experienced team to manage this important program."
Cell-based systems for production of vaccines offer a number of potential benefits over more traditional, chicken egg-based systems. Baxter's vero-cell system is capable of producing high yields of influenza virus without the addition of any animal-derived serum. Through the company's research and development work, Baxter has been successful in growing wild-type virus in its vero-cell culture, which means that the company could begin vaccine production without having to wait for high-growth or attenuated virus reassortants normally used when vaccine is produced in eggs.
"The threat of a pandemic is very real and with cases of H5N1 avian influenza appearing in new geographic areas, governments are taking notice," said John Oxford, professor of virology at St. Bartholomew's and the Royal London Hospital, Queen Mary's School of Medicine. "Baxter's use of vero-cell technology is a welcome advance in the production of influenza vaccine for both seasonal and pandemic influenza."
Baxter is working with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to develop a cell culture-based H5N1 candidate pandemic influenza vaccine. Baxter will be providing the candidate vaccine to NIAID for clinical testing in the United States, which is expected to begin in 2006. In addition, Baxter is in discussions with several other governments regarding its candidate pandemic vaccine, and has recently been awarded a contract to supply 2 million doses of a candidate H5N1 vaccine to the U.K. government.
Over the years, the company has partnered with governments around the world to develop and produce vaccines and other therapeutics to protect against bioterrorism and infectious diseases. In partnership with Acambis Inc., Baxter has supplied stockpiles of vero cell-derived smallpox vaccine to the U.S. government and 12 countries worldwide. In Fall 2003, the company was awarded a contract by the NIAID in the United States to develop and produce an inactivated coronavirus vaccine against Severe Acute Respiratory Syndrome (SARS) for use by the NIH in phase I/II clinical trials. In 2005, Baxter, in partnership with DVC, was awarded a contract for the development of a plasma- based therapeutic targeted for use in individuals who may be exposed to nerve gas poisons.
Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This release includes forward-looking statements concerning the company's vaccine products, including with respect to clinical trials, licensures, and the advantages of the vaccine products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements for timely commencement of additional clinical trials; additional clinical results demonstrating the safety and efficacy of the products; market acceptance of vaccines developed with vero-cell technology relative to egg-based or other alternatives; continued public commitment to addressing avian flu and other pandemic threats; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's web site. The company does not undertake to update its forward- looking statements.
Baxter International Inc.CONTACT: Media, Deborah Spak, +1-847-948-2349, Tom Kline, +1-847-948-2251,Investor, Mary Kay Ladone, +1-847-948-3371, Clare Sullivan,+1-847-948-3085, all of Baxter International Inc.
Web site: http://www.baxter.com/
