08 Mar, 2017, 09:20 ET
FALLS CHURCH, Va., March 8, 2017 /PRNewswire/ -- CSRA Inc. (NYSE:CSRA) today announced that a plague vaccine being developed by its subsidiary, DynPort Vaccine Company LLC (DVC), was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). DVC is developing the recombinant rF1V plague vaccine on behalf of the U.S. Department of Defense (DoD). The vaccine will be used for pre-exposure prophylaxis to combat infection with Yersinia pestis, the causative agent of plague. DVC is a contractor for the Medical Countermeasure Systems Joint Vaccine Acquisition Program (MCS-JVAP) and the sponsor of the associated Investigational New Drug Application for the plague vaccine.
"We are excited the FDA has granted Orphan Drug status for rF1V vaccine," said Gary S. Nabors, Ph.D., President of DVC. "Orphan Drug Designation provides important incentives to support the development of products for rare diseases. These incentives include the waiving of prescription drug user fees and the ability to market the vaccine exclusively in the U.S. for seven years following approval."
The plague vaccine is being developed as an important component of the DoD's medical countermeasures portfolio against bioterrorism agents. Drugs and biologics developed for this vaccine must receive orphan status through the FDA's Orphan Drug Designation program. The orphan status applies to those drugs and biologics intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Currently, no licensed vaccines against plague are available for human use in the US. The vaccine is intended to be administered to individuals considered to be at high risk for exposure to aerosolized Y. pestis.
Plague is an acute, and often fatal, disease caused by infection with Y. pestis, a gram-negative bacterium. Historically, the disease has resulted in three pandemics over the last 1,700 years. It is estimated to have caused 200 million deaths worldwide. Plague is currently viewed as a possible agent of bioterrorism. As such, it has been classified as a Category A priority pathogen by both the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC). The rF1V vaccine was originally developed by scientists at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID).
This work was funded by the Medical Countermeasures Systems-Joint Vaccine Acquisition Program (MCS-JVAP), Department of Defense (DoD) Contract DAMD17-98-C-8024 and does not represent official DoD positions, policies or decisions.
About CSRA Inc.
CSRA (NYSE: CSRA) solves our nation's hardest mission problems as a bridge from mission and enterprise IT to Next Gen, from government to technology partners, and from agency to agency. CSRA is tomorrow's thinking, today. For our customers, our partners, and ultimately, all the people our mission touches, CSRA is realizing the promise of technology to change the world through next-generation thinking and meaningful results. CSRA is driving towards achieving sustainable, industry-leading organic growth across federal and state/local markets through customer intimacy, rapid innovation and outcome-based experience. CSRA has over 18,000 employees and is headquartered in Falls Church, Virginia. To learn more about CSRA, visit www.csra.com. Think Next. Now.
All statements in this press release and in all future press releases that do not directly and exclusively relate to historical facts constitute "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements represent CSRA's intentions, plans, expectations and beliefs, including statements about the effects of the program on our business and our ability to enhance mission capabilities of our customers. The forward-looking statements are subject to risks, uncertainties and other factors, many of which are outside the control of CSRA. These factors could cause actual results to differ materially from forward-looking statements. For a written description of these factors, see the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in CSRA's most recent Annual Report on Form 10-K and any updating information in subsequent SEC filings. CSRA disclaims any intention or obligation to update these forward-looking statements whether as a result of subsequent event or otherwise.
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