To: Brett Fleischman who wrote (20774 ) 5/22/1998 11:40:00 AM From: cool Respond to of 34592
ORVX--7 M float--some DD-- OraVax, Inc. Joins DynPort In Department of Defense Contract To Develop FDA-Licensed Vaccines Against Potential Biological Warfare Agents CAMBRIDGE, Mass., May 04 /PRNewswire/ -- OraVax, Inc. (Nasdaq: ORVX - news) announced today its participation in a defense contract awarded to DynPort L.L.C., as Prime Systems Integration Contractor. The contract is for the Joint Vaccine Acquisition Program (JVAP) of the U.S. Department of Defense (DoD). DynPort's proposal was chosen from four bids offered to the Department of Defense's public Request for Proposals. OraVax is working with DynPort and the JVAP office to refine plans for the advanced development and routine manufacture of selected vaccines under this contract. Several vaccines are anticipated to be manufactured by OraVax at its Canton, Massachusetts production facility. The Joint Vaccine Acquisition Program is a $322 million, 10-year program for the development, production, testing, FDA licensure and storage of vaccines to protect U.S. armed forces against potential biological warfare agents. The JVAP is implemented by the DoD through the Joint Program Office for Biological Defense, for which the U.S. Army is the lead agency. This program was developed to ensure that the military will have access to a supply of FDA-approved vaccines effective against potential biological warfare agents. The vaccines under the JVAP will be subject to the same scrutiny and rigorous examination the FDA applies to vaccine products for civilian use. ''Recent current events show just how vital it is to be prepared to protect against the threat of biologic warfare,'' said Lance K. Gordon, Ph.D., President and Chief Executive Officer of OraVax. ''We are very pleased to have the opportunity to manufacture a series of vaccines that are important for national defense. Once approved by the FDA, these products could also be made more broadly available to counter the consequences of biologic warfare.'' Dr. Gordon also added, ''Performance under this contract should provide a long-term, stable business unit to the Company that should extend our manufacturing operations and facilitate OraVax's own proprietary product manufacture.'' DynPort, as prime contractor, and OraVax, as manufacturer for specified products, will receive the existing investigational vaccines from the Department of Defense and will work with product managers at the JVAP office to further establish the safety and efficacy required for licensure by the FDA. OraVax is a Cambridge, Massachusetts biopharmaceutical company engaged in the discovery and development of innovative vaccines and antibody products to prevent or treat human infectious diseases. The Company's largest program, Helicobacter pylori (H. pylori), is a joint venture with Pasteur Merieux Connaught to develop vaccines against peptic ulcers and stomach cancer. OraVax is also developing HNK20, a monoclonal IgA antibody nosedrop for prevention of infant viral pneumonia caused by respiratory syncytial virus (RSV), and both a vaccine and a stimulated-immune globulin for the prevention of colitis caused by Clostridium difficile, a common complication of broad- spectrum antibiotic therapy. Additionally, the Company is developing the ChimeriVax(TM) family of single-dose genetically-engineered vaccines based on the yellow fever YF 17D vaccine strain virus. The first of these vaccines, targeting the Japanese encephalitis virus, is currently in advanced preclinical development. Earlier stage research programs include vaccines against dengue, tick borne encephalitis and hepatitis C viral infections.