State Issues First Permit for the Production of Pharmaceuticals in Corn

Date: May 14, 2003

Contact: Jim Miller 303.239.4103 or Jim Rubingh 303.239.4114

The Colorado Department of Agriculture today granted conditional concurrence to clear the production of a small plot of corn in Phillips County containing a pharmaceutical protein. The permit, submitted by Meristem Therapeutics of France, will allow the planting of up to 30 acres of corn that will produce an experimental pharmaceutical designed to aid sufferers of cystic fibrosis.

The department’s conditional concurrence with the permit proposed by the U.S. Department of Agriculture was based on the recommendation of a panel of experts that reviewed the application. The panel consisted of faculty of the University of Colorado and Colorado State University who held expertise in microbiology and plant science.

“I am convinced that production of pharmaceuticals using biotechnology can be accomplished in Colorado safely and without threat to our agricultural markets or to the consumer of our food products,” said Agriculture Commissioner Don Ament. “However,” Ament cautioned, “any company that comes to Colorado to grow biotech pharmaceutical or industrial-use crops must be aware that our standards for performance are exceedingly high and as an agency, the Colorado Department of Agriculture intends to see to it that those standards are met.”

The application for a permit to grow the crop was submitted to Colorado on May 7, 2003 for the state’s review and comment. Under USDA rules, states may take up to 30 days to review the applications and offer or withhold their concurrence with the terms of the permit. While states may not block the planting of pharmaceutical or other experimental biotech crops, USDA has indicated that state comments will be given highest consideration.

The Agriculture Department offered its concurrence to the terms of the permit with three conditions. First, the department is insisting that state agriculture department inspectors be permitted to accompany USDA inspectors on each site visit to be sure permit conditions are being met. Secondly, the state ag department is insisting that the number of inspections be set at a minimum of five during specific times within the permit period. Third, the department is to be allowed to inspect the plots any time the agency deems necessary, provided prior notice has been given to the permittee.

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Fact Sheet Regarding the Meristem Therapeutics Permit to Grow a Plant-Made Pharmaceutical in Phillips County, Colorado

Applicant: Meristem Therapeutics, Cambridge, MA Pierre Dorfman, M.D., Medical and Regulatory Affairs Director

Contact: Emmanuel Boures, Communication Director. Meristem Therapeutics, Clermont-Ferrand, France. eboures@meristem-therapeutics.com

Fax: +33 473 98 68 19 or

Local contact: Jennifer McCallum, Ph.D., Esq., The McCallum Law Firm, LLC. Phone: 303.828.0655

Pharmaceutical: Recombinant mammalian gastric lipase to aid in treatment of cystic fibrosis