ST. LOUIS, Jan. 2 /PRNewswire-FirstCall/ -- Monsanto Company announced today that the U.S. Department of Agriculture (USDA) has granted deregulated status for its MON88017 -- a second-generation product combining its rootworm and Roundup Ready(R) Corn 2 trait technologies in a single event; and MON88017 stacked with YieldGard(R) Corn Borer. These regulatory clearances represent a major step toward the future commercialization of these products.
The USDA deregulation was based on a comprehensive Plant Protection Act risk assessment of MON88017. The U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) had completed their reviews of MON88017 previously.
"Over the last two decades, Monsanto scientists have focused on researching and delivering meaningful products to our farmer customers," said Robert T. Fraley, Ph.D., executive vice president and chief technology officer for Monsanto. "Today's announcement represents a significant milestone demonstrating our company's leadership in developing and registering second generation insect and weed control biotech products as well."
About the MON88017 Event
MON88017 is a vector stack of Monsanto's Rootworm and Roundup Ready Corn 2 trait offerings. This means that the rootworm-control gene is already combined with the glyphosate-tolerance gene when the genetic package is inserted into the plant. Previously, corn hybrids containing both the corn rootworm protection and glyphosate tolerance traits have been developed by crossing two inbreds containing the individual traits using traditional breeding techniques. However, the traditional breeding process can be inefficient, requiring a longer development time. MON88017 was therefore developed using a transformation vector that contained both of the genes in one genetic package. This approach enables the simultaneous introduction of both traits into corn hybrids, thereby reducing breeding costs and increasing the speed at which elite corn germplasm can be provided to corn growers.
The product's YieldGard Rootworm corn technology allows the corn plant to naturally protect its roots against the damaging corn rootworm. The corn rootworm has earned the nickname the "billion-dollar pest" as the USDA estimates that this pest causes $1 billion in lost revenue annually to the U.S. corn crop. Monsanto's current YieldGard Rootworm product is estimated to have been planted on more than four million acres in 2005. Monsanto estimates that its YieldGard Rootworm corn technology has an available market of 25 to 30 million acres in the U.S. over the long term.
The product's Roundup Ready Corn 2 technology provides growers with crop safety and unsurpassed weed control with Roundup agricultural herbicides. Roundup Ready corn technology is estimated to have been planted on 24 million acres in the U.S. in 2005. The company estimates that the Roundup Ready corn technology has an available market potential to reach 60 million acres over the long term. Recent company estimates suggest the combined acres of Roundup Ready Corn 2 and YieldGard Rootworm technologies will expand again in 2006 to 44M acres.
Commercial Offerings Expected in the Future
Monsanto is seeking the necessary regulatory clearances for MON88017 and MON88017 stacked with YieldGard Corn Borer on the U.S. state level and approvals in countries that are major importers of U.S. corn. Commercial launch timing for these products has not been announced. This second- generation YieldGard Rootworm technology is expected to be made available for planting in corn hybrids through Monsanto's branded seed businesses - DEKALB(R) and Asgrow(R) - American Seeds, Inc. companies as well as through licensed, independent seed companies.
Monsanto's 2005 field research demonstrated that MON88017 provided outstanding performance for corn rootworm control along with safety to the application of Roundup agricultural herbicides. Monsanto has not announced a trade name for this technology at this time, and will refer to it as MON88017 until it completes the branding process.
Monsanto Company is a leading global provider of technology- based solutions and agricultural products that improve farm productivity and food quality. For more information on Monsanto, see: http://www.monsanto.com/
Cautionary Statements Regarding Forward-Looking Information:
Certain statements contained in this release are "forward-looking statements," such as statements concerning the company's anticipated financial results, current and future product performance, regulatory approvals, business and financial plans and other non-historical facts. These statements are based on current expectations and currently available information. However, since these statements are based on factors that involve risks and uncertainties, the company's actual performance and results may differ materially from those described or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, among others: continued competition in seeds, traits and agricultural chemicals; the company's exposure to various contingencies, including those related to intellectual property protection, regulatory compliance and the speed with which approvals are received, and public acceptance of biotechnology products; the success of the company's research and development activities; the outcomes of major lawsuits, including proceedings related to Solutia Inc.; developments related to foreign currencies and economies; successful completion and operation of recent and proposed acquisitions; fluctuations in commodity prices; compliance with regulations affecting our manufacturing; the accuracy of the company's estimates related to distribution inventory levels; the company's ability to fund its short-term financing needs and to obtain payment for the products that it sells; the effect of weather conditions, natural disasters and accidents on the agriculture business or the company's facilities; and other risks and factors detailed in the company's filings with the SEC. Undue reliance should not be placed on these forward-looking statements, which are current only as of the date of this release. The company disclaims any current intention or obligation to update any forward-looking statements or any of the factors that may affect actual results.
