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Bayer Broadens Its Manufacturing Basis for Biopharmaceuticals in Tobacco Plants

Monday, September 29, 2008 General News J E 4
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LEVERKUSEN, Germany and OWENSBORO, Ky., Sept. 29 BayerInnovation GmbH and Kentucky Bioprocessing, LLC (KBP) are collaborating todevelop a facility at KBP's Owensboro plant in the US state of Kentucky forthe production service of biopharmaceuticals. Based on Bayer's proprietarymagnICON(R) technology, plant made pharmaceutical proteins (PMP) and otherhigh-value products will be produced in tobacco plants on commercial scale.

Under terms of the agreement, KBP will adapt its existing cGMP (cGMP =current Good Manufacturing Practice) compliant facility by installing anautomated system for high throughput transfection of tobacco host plants. Theagreement makes KBP the "preferred production partner" for the application ofmagnICON(R), an innovative technology for the fast high-yield production ofproteins in tobacco plants.

Bayer has internal product development projects - for example a vaccinefor the therapy of Non-Hodgkin-Lymphoma - based on the magnICON(R) platform.Beyond that Bayer is also in the process of licensing out this technology toseveral parties. "To accelerate these applications of this technology, wedecided to team up with an experienced external manufacturer, and KBP, withits excellent facilities and highly qualified personnel is the best choice inour view," said Dr. Detlef Wollweber, General Manager of Bayer Innovation.

"Bayer and its subsidiary, Bayer Innovation, are among the highestregarded participants in the PMP sector," said KBP Chairman Hugh Haydon. "Ourassociation with them is not only important for the growth of KBP, but webelieve is also significant in the evolution and development of the PMPindustry in Owensboro and worldwide."

Construction on the magnICON(R) related improvements at KBP is scheduledto begin in October 2008. Completion and initial testing of the new facilitiesis planned for spring of 2009.

The magnICON(R) technology is a new generation proprietary process forrapid, high-yield production of recombinant proteins, such asbiopharmaceuticals, in tobacco plants. It does not require genetic engineeringof plants, but instead relies on a blueprint for the desired product deliveredtemporarily to the plant using a soil bacterium. Entire plants are infiltratedwith a highly diluted suspension of bacteria carrying the blueprint. Theprocess has been shown to work with over 50 different pharmaceutical proteinson laboratory scale and it can be performed on an industrial scale in a fullycontained manufacturing facility. The speed and yield of magnICON(R) offersnew prospects for substances which have previously been impractical because ofthe length of time needed to produce them, or cost of their manufacturing.

About Kentucky Bioprocessing, LLC

KBP (www.kbpllc.com) is located in Owensboro, Kentucky and maintains ahighly experienced staff and facilities focused on expression, extraction,purification and commercial scale production of proteins and other productsfrom plants. KBP offers clients and collaborators access to controlled plantgrowth facilities along with bench, pilot and full-scale processing facilitiescapable of production under cGMP conditions. In addition to its owncapabilities KBP is able to leverage the experienced staff and facilities ofthe Owensboro Cancer Research Program and provides linkages to theconsiderable plant-made product expertise of the Owensboro area agriculturecommunity and to other services offered throughout the region designed tosupport research, development and growth of a plant-made product businesscluster.

About Bayer Innovation GmbH and Icon Genetics

Bayer Innovation GmbH (BIG), a wholly owned subsidiary of Bayer AG,evaluates and develops new fields of business for the Bayer Group are relatedto Bayer's core competencies of health care, nutrition and innovativematerials and complement its current key areas of innovation and business.

Icon Genetics is a wholly owned subsidiary of Bayer Innovation GmbH; itwas established in 1999 and acquired by Bayer in 2006. The company developsprocesses for the biotechnological production of proteins and other high-valueproducts in plants.

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the fields ofhealth care, nutrition and high-tech materials. The company's products andservices are designed to benefit people and improve their quality of life. Atthe same time Bayer creates value through innovation, growth and improvedearning power. The Group is committed to the principles of sustainabledevelopment and acknowledges and accepts its role as a socially and ethicallyresponsible "corporate citizen". Economy, ecology and social responsibilityare corporate policy objectives of equal rank. In fiscal 2007, Bayer employed106,200 people and had sales of EUR 32.4 billion. Capital expendituresamounted to EUR 1.9 billion, the R&D budget to EUR 2.6 billion. Moreinformation is available on the Internet at www.bayer.com

Forward-Looking Statements

This release may contain forward-looking statements based on currentassumptions and forecasts made by Bayer Group or subgroup management. Variousknown and unknown risks, uncertainties and other factors could lead tomaterial differences between the actual future results, financial situation,development or performance of the company and the estimates given here. Thesefactors include those discussed in Bayer's public reports which are availableon the Bayer website at www.bayer.com . The company assumes no liabilitywhatsoever to update these forward-looking statements or to conform them tofuture events or developments.

SOURCE Kentucky Bioprocessing, LLC; Bayer Innovation GmbH
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