DAVIS, CA – September 14, 2015 – Marrone Bio Innovations, Inc. (MBI), (NASDAQ: MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, announced today that its GRANDEVO bioinsecticide has received a completeness determination from the European Commission and is now cleared to begin the evaluation for Annex 1 listing and commercialization in the European Union. A June 25th policy decision by the European Commission, the European Food Safety Authority and a Working Group of EU Member States, has allowed GRANDEVO, an innovative biopesticide containing only non-viable Chromobacterium subtsugae cells, to be evaluated as a microbial pesticide. Until this recent EU decision, only pesticides containing live microbes could be evaluated under EU regulation. GRANDEVO is the first ever bioinsecticide formulated as a non-viable microbial “end product” to be accepted for review as a microbial pesticide by EU regulators and to receive a favorable completeness check decision.
Grandevo is being assessed under the Netherlands Government’s “Green Deal” Initiative, which has been created with an aim to “speed up the sustainability of PPPs (plant protection products) in agriculture and horticulture by facilitating the authorization of green PPPs with a low risk for humans, animals and the environment”, according to ctgb (Board for the Authorisation of Plant Protection Products and Biocides).
MBI believes that efficacy trials recently completed in Europe will be used to support the potential uses of Grandevo for the control of whitefly and thrips in Solanaceae (tomato, pepper and aubergine) and Cucurbitaceae (melon, cucumber and squash) crops.
Keith Pitts, MBI’s VP of Regulatory and Government Affairs said, “receiving this completeness determination for Grandevo from the Netherlands is an important step in making the potential benefits of new biopesticide products available to growers throughout the EU. The Netherlands’ Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), the European Commission Directorate-General for Health and Food Safety (DG-SANTE) and the International Biocontrol Manufacturers Association were instrumental in supporting Marrone Bio Innovations to achieve this completeness determination. MBI looks forward to working with Ctgb and other EU regulatory agencies on the next steps in the evaluation and potential registration process of GRANDEVO in Europe.”
GRANDEVO is an advanced broad-spectrum bioinsecticide that offers protection against chewing and sucking insects and mites including thrips, whiteflies, Asian citrus psyllid, armyworms and other pest caterpillars, mites, Lygus bug, mealybugs, and soil-inhabiting pests. The active ingredient in GRANDEVO bioinsecticide is a microbe with insecticidal properties produced during the fermentation manufacturing process. GRANDEVO has multiple modes of action that makes the product an excellent addition to insect resistance management programs. This reduced risk of resistance is a benefit in solving an increasing problem that hampers growers’ ability to control crop-damaging pests. GRANDEVO—used alone or with synthetic insecticides, in rotation or in a tank mix—can help growers manage pests better and extend the useful life of other products.
About Marrone Bio Innovations
Marrone Bio Innovations, Inc. (NASDAQ: MBII) is a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets. Our effective and environmentally responsible solutions help customers operate more sustainably while controlling pests, improving plant health, and increasing crop yields. We have a proprietary discovery process, a rapid development platform, and a robust pipeline of pest management and plant health product candidates. At Marrone Bio Innovations we are dedicated to pioneering better biopesticides that support a better tomorrow for users around the globe. For more information, please visit www.marronebio.com.
Forward Looking Statements
Portions of this press release may constitute “forward-looking statements,” and assumptions underlying such forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”), Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any such forward-looking statements are made within the “safe-harbor” protections of the PSLRA, should not be relied upon as representing our views as of any subsequent date, and we are under no obligation to, and expressly disclaims any responsibility to, update or alter these forward-looking statements, whether as a result of new information, future events or otherwise. Forward-looking statements in this filing include those regarding Grandevo, including its potential uses, availability in the EU and registration with applicable agencies. Such forward-looking statements are based on information available to us as of the date of this release and involve a number of risks and uncertainties, some beyond our control, that could cause actual results to differ materially from those anticipated by these forward-looking statements. Such risks include inability to obtain regulatory approval for or commercialize our products, or to comply with ongoing and changing regulatory requirements, which could delay or prevent sales, failure of customers to adopt our products and competition in the markets for our products. Additional information that could lead to material changes in our performance is contained in our filings with the Securities and Exchange Commission.