GenVec Announces Conditional Approval of FMD Vaccine for Cattle
GAITHERSBURG, Md., June 7, 2012 /PRNewswire via COMTEX/ -- GenVec, Inc. (GNVC)
today announced that the U.S. Department of Agriculture's Animal and Plant Health
Inspection Service (APHIS) has issued a conditional license for GenVec's
foot-and-mouth disease (FMD) vaccine for use in cattle. APHIS issued the
conditional license to Antelope Valley Bios, Inc., who manufactured the vaccine
under a contract from GenVec. The vaccine was developed and tested under a
contract with the U.S. Department of Homeland Security's Science and Technology
Directorate. This is the first FMD vaccine licensed by the USDA Center for
Veterinary Biologics.
"This conditional approval is a significant event as it represents GenVec's first
approved product," noted Bryan T. Butman, Ph.D., GenVec's Senior Vice President
of Vector Operations and the Head of GenVec's FMD program. "This achievement
demonstrates GenVec's ability to bring its technology through the regulatory
review process and validates the utility of our core technology to make effective
genetic vaccines."
The FMD vaccine, initially discovered and tested by the USDA Agricultural
Research Service (ARS), was developed by GenVec scientists in collaboration with
the DHS S&T Directorate's Targeted Advanced Development Branch at Plum Island
Animal Disease Center.
GenVec's novel FMD vaccine approach utilizes GenVec's proprietary adenovector
technology and is manufactured on a proprietary GenVec cell line that is capable
of producing antigens without the use of the highly contagious FMD virus. Because
the vaccine is produced without using live or killed virus materials, it can be
produced cost effectively in the U.S. and around the world.
Under the conditional license, the product may be distributed as authorized by
Federal emergency management officials within USDA, should the need for the
product arise. APHIS issues conditional licenses in the event of an emergency
situation, limited market or other special circumstance. In this case, the
special circumstance was the need for an FMD vaccine that was capable of being
manufactured in the U.S. that allowed for the differentiation between infected
and vaccinated animals. The vaccine will now be available to agriculture
officials in the event of an FMD emergency situation.
In a related, but separate effort, GenVec has licensed to Merial, the animal
health division of Sanofi, the rights to develop and commercialize GenVec's
proprietary vaccine technology for use against foot-and-mouth disease in cattle.
About Foot-and-Mouth Disease
Foot-and-mouth disease (FMD) is a severe, highly contagious viral disease of
cloven-hooved animals. Although not usually fatal, it causes suffering and vastly
reduces animals' commercial value by reducing their weight and milk output.
Clinical signs include fever and blister-like lesions, excessive salivation,
lameness and decreased feed consumption. FMD is widely believed to be the most
economically devastating livestock disease in the world. While the United States
has not had an outbreak of FMD since 1929, the highly contagious nature of FMD,
and the grave economic consequences of an outbreak, has made developing a vaccine
and anti-viral candidates a high priority of the U.S. government.
About GenVec
GenVec is a biopharmaceutical company using differentiated, proprietary
technologies to create superior therapeutics and vaccines. A key component of our
strategy is to develop and commercialize our product candidates through
collaborations. GenVec is working with leading companies and organizations such
as Novartis, Merial, and the U.S. Government to support a portfolio of product
programs that address the prevention and treatment of a number of significant
human and animal health concerns. GenVec's development programs address
therapeutic areas such as hearing loss and balance disorders; as well as vaccines
against infectious diseases including respiratory syncytial virus (RSV), herpes
simplex virus (HSV), dengue fever, influenza, malaria, and human immunodeficiency
virus (HIV). In the area of animal health, we are developing vaccines against
foot-and-mouth disease (FMD). Additional information about GenVec is available at
genvec.com and in the Company's various filings with the Securities
and Exchange Commission. |
