DAVIS, Calif. & ROSARIO, Argentina--(BUSINESS WIRE)--Aug. 26, 2015--
Arcadia Biosciences, Inc. (NASDAQ: RKDA) and Bioceres S.A. announced
today that Verdeca, their soybean technology joint venture, received
notification that the US Food and Drug Administration (FDA) has
completed the Early Food Safety Evaluation (EFSE) process for HAHB4, the
plant protein responsible for Verdeca’s HB4 stress tolerance trait.
Completion of this review is a major milestone in the development of
commercial soybean seed products based on the HB4 stress tolerance
trait, as well as the development of HB4-based products in other crops.
This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20150826005216/en/
In the EFSE process, the FDA reviewed safety data provided by Verdeca
and supported the conclusion that the inadvertent presence of low levels
of the HAHB4 protein would not raise food safety concerns. 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.
Since 1992, the FDA has encouraged developers of new plant varieties,
including those varieties developed through biotechnology, to consult
with the agency early in the development process to discuss possible
scientific and regulatory issues that might arise. The EFSE process
accomplishes this objective by reviewing data and conclusions on the
protein introduced to a variety, addressing potential allergic reactions
and toxicity for humans or animals. By conducting an early evaluation of
a protein and finding no food safety concerns, the FDA would then not
expect an additional early food safety evaluation to be submitted if the
same protein is introduced into another plant species.
“Soybean seed products based on the HB4 stress tolerance trait are in
the latter stages of development, and completion of the EFSE process is
a very strong and positive signal about safety,” said Eric Rey,
president and CEO of Arcadia Biosciences. “The core safety data used in
the EFSE process will facilitate international regulatory approvals for
HB4 stress-tolerant soybeans, and for the use of the HB4 trait in other
crops as well.”
“FDA conclusions are of great significance to regulators around the
globe and constitute a valuable reference for present and future
submissions concerning HB4 seeds,” said Federico Trucco, CEO of
Bioceres. “As more regulatory agencies review the safety data and gain
confidence in the safety of HB4 products, we hope to be able to expedite
the pending regulatory processes required for the commercial launch of
the technology.”
Verdeca’s HB4 soybeans have undergone extensive testing,
including six seasons of multi-location field trials in Argentina and
the United States and three years of regulatory field trials. The
results of these trials demonstrate that the HB4 trait can provide up to
a 14 percent yield advantage under multiple stress conditions –
including drought and low-water conditions – typically found in soybean
production areas.
The FDA’s evaluation follows the April regulatory approval from
Argentina’s National Advisory Commission on Agricultural Biotechnology
(CONABIA) and the Biotechnology Directorate from the Ministry of
Agriculture, Livestock and Fisheries of Argentina. The Argentinian
approval was the first regulatory approval for the HB4 trait, and the
world’s first regulatory approval of an abiotic stress tolerance trait
in soybeans.
Along with this key regulatory milestone, Verdeca recently announced
significant partnerships that will advance the development of high-value
traits in soybeans. In July, Bioceres, Arcadia, and Tropical
Melhoramento e Genética Ltda. (TMG) announced a collaboration to develop
and commercialize Verdeca’s HB4 stress tolerance trait in soybeans. And
earlier this year, Verdeca announced a collaboration with Dow
AgroSciences to develop soybean trait stacks that combine Verdeca’s
agronomic performance and product quality traits with Dow AgroSciences’
herbicide tolerance and insect resistance traits.
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., with additional facilities in Seattle, Wash. and
Phoenix, Ariz., 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. The company was recently listed in the Global Cleantech 100 and
was previously named one of MIT Technology Review's 50 Smartest
Companies. For more information, visit www.arcadiabio.com.
About Bioceres
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 INDEAR (Institute of
Agricultural Biotechnology of Rosario) and Bioceres Semillas. For more
information visit www.bioceres.com.ar.
About Verdeca
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
Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 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/20150826005216/en/
Source: Arcadia Biosciences, Inc.
Arcadia Biosciences, Inc.
Jeff Bergau, +1-312-217-0419
jeff.bergau@arcadiabio.com
