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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.
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