-- FDA Grants Clearance for Use in Human Food and Animal Feed --
DAVIS, Calif. & ROSARIO, Argentina--(BUSINESS WIRE)--Aug. 10, 2017--
Arcadia Biosciences, Inc. (Nasdaq: RKDA) and Bioceres S.A. announced
today their joint venture, Verdeca, received notification that the U.S.
Food and Drug Administration (FDA) has completed its full review of the
company’s safety evaluation for HB4 soybeans. The FDA’s notice to
Verdeca allows products derived from HB4 soybeans to be used
commercially in human food and animal feed. This is a major milestone in
the development of commercial soybean seed products based on the HB4
stress tolerance trait.
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The FDA uses its Biotechnology Notice process to review and assess
safety data provided by companies developing new plant varieties using
advanced breeding technologies. The data provided to the FDA is
consistent with international regulatory requirements for genetically
modified crops and will be used by Verdeca and its global partners for
future regulatory submissions.
Verdeca’s HB4soybeans have undergone extensive testing,
including multi-location field trials in Argentina and the United States
and multiple regulatory field trials. The results of these trials
demonstrate that the HB4 trait can provide yield advantages under stress
conditions – including drought and low-water conditions – found in
several soybean production areas.
“The HB4 gene holds great promise for bringing better yield stability to
agriculture in areas that experience chronic water stress problems,”
said Raj Ketkar, president and CEO of Arcadia Biosciences. “Our combined
efforts aim to create significant value for soybean growers by
increasing the productivity and sustainability of this important protein
crop in the face of global climate challenges.”
“The FDA is one of the most prestigious regulatory agencies in the world
and its opinions are of reference to regulators everywhere,” said
Federico Trucco, CEO of Bioceres. “In a way, this FDA clearance
testifies to the quality standards implemented in HB4 product
development and safety evaluations. We hope this decision will help
expedite international regulatory clearances for HB4 soybeans, and bring
us closer to the much anticipated launch of this unique technology.”
Completion of the FDA’s review is another key regulatory achievement in
the approval process for Verdeca’s HB4 drought stress tolerance trait.
The trait has already been approved in Argentina by the Ministry of
Agriculture, Livestock and Fisheries.
Verdeca has also submitted an environmental safety data petition to the
US Department of Agriculture (USDA), and this submission is currently
under review. Upon completion, the USDA is expected to issue a
Determination on Nonregulated Status, which will complete the approval
processes in the US and allow for commercial production of HB4 soybeans.
Soybeans are the world’s fourth-largest crop, grown on 110 million
hectares worldwide. Global demand is projected to increase over the next
decade as a result of population growth and the expanding middle class
in highly populated countries such as India and China. South America is
the world’s largest exporter of soybeans to both developed and
developing countries, and more than 45 percent of the world’s soybeans
are grown in Argentina and Brazil. Verdeca is developing multiple
agronomic performance and product quality traits in soybeans to give
farmers new options to help increase productivity and total value.
About Arcadia Biosciences, Inc.
Based in Davis, Calif., Arcadia Biosciences (Nasdaq: RKDA) develops
agricultural products that create added value for farmers while
benefitting the environment and enhancing human health. Arcadia’s
agronomic performance traits, including Nitrogen Use Efficiency, Water
Use Efficiency, Salinity Tolerance, Heat Tolerance and Herbicide
Tolerance, are all aimed at making agricultural production more
economically efficient and environmentally sound. Arcadia’s nutrition
traits and products are aimed at creating healthier ingredients and
whole foods with lower production costs. For more information, visit www.arcadiabio.com.
Bioceres is a fully integrated agricultural biotechnology company
utilizing multiple technology platforms to develop and commercialize
products that enhance crop productivity and expand feedstock
applications. The company is owned by more than 250 of South America’s
largest growers. Bioceres is a major shareholder of Rizobacter, INDEAR
(Institute of Agricultural Biotechnology of Rosario), and Bioceres
Semillas. For more information visit www.bioceres.com.ar.
Verdeca, a U.S.-based joint venture between Bioceres and Arcadia
Biosciences, develops and deregulates soybean varieties with
next-generation agricultural technologies. Working in partnership with
South American growers, Verdeca aims to provide technologies that help
increase crop productivity, making more efficient and sustainable use of
land and water resources. For more information visit www.verdeca.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to Verdeca’s HB4 trait and the regulatory
process for such trait. Forward-looking statements are subject to risks
and uncertainties that could cause actual results to differ materially,
and reported results should not be considered as an indication of future
performance. These risks and uncertainties include, but are not limited
to: Arcadia’s and its partners’ and affiliates’ ability to develop
commercial products incorporating their traits, including the HB4 trait,
and complete the regulatory review process for such products; Arcadia’s
compliance with laws and regulations that impact Arcadia’s business, and
changes to such laws and regulations; Arcadia’s future capital
requirements and ability to satisfy its capital needs; and the other
risks set forth in Arcadia’s filings with the Securities and Exchange
Commission from time to time, including the risks set forth in Arcadia’s
Annual Report on Form 10-K for the year ended December 31, 2016 and
other filings. These forward-looking statements speak only as of the
date hereof, and Arcadia Biosciences, Inc. disclaims any obligation to
update these forward-looking statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170810005339/en/
Source: Arcadia Biosciences, Inc.
Jeff Bergau, +1-312-217-0419