ProdiGene and Sigma-Aldrich announce an agreement to manufacture and distribute recombinant maize-derived trypsin

College Station, Texas
October 9, 2002

ProdiGene, Inc. and Sigma-Aldrich Fine Chemicals, a division of Sigma-Aldrich Corporation (NASDAQ:SIAL), announced today they have entered into an agreement under which Sigma-Aldrich will manufacture and distribute TrypZean(TM), an animal free recombinant trypsin produced with ProdiGene's proprietary transgenic plant system.

Sigma-Aldrich, well known for its expertise in protein production and processing, has made sizeable commitments to transgenic plant processing capabilities, including the ability to process proteins in an animal contamination free environment. "Based on our development experience with ProdiGene this is a very scalable process," remarks Dr. Cynthia Wooge, Sigma-Aldrich's Manager, Process Development. "We expect the full scale production process to be completed before year end."

This is the first product launch by any company of a large-scale transgenic plant protein. Robert C. Dose, Vice President Business Development observes, "We have been supplying sample material to the pharmaceutical industry for over six months and the response has been overwhelming, confirming our market intelligence of a large demand for an animal free product such as TrypZean(TM)."

About Trypsin

Trypsin is a naturally occurring protein that is produced in the pancreas of all animals and breaks down protein chains as part of the digestion process. It is a critical intermediary in the bioprocessing of proteins, such as insulin, where it is used to help cleave the protein into its active form. The market for trypsin is rapidly growing as a result of the worldwide increase in biological products and diseases that are treated with biological proteins, such as diabetes. Trypsin is widely used in cell culture applications for research and production of recombinant proteins for clinical uses. Another application is its use in the wound care markets as an oral treatment for inflammatory edema, hematoma and pain associated with a wide variety of internal and external wounds. The protein also has uses in food processing and infant formulas.

Concerns surrounding the use of animal and human-derived proteins in pharmaceutical manufacturing make ProdiGene's expertise in the area of plant produced recombinant proteins an attractive alternative. The technology offers an animal free source of proteins as well as the capacity to produce large volumes that can be easily scaled-up or down without risk of significant capital investment. "We have performed numerous studies and examined test data from customers' studies all with very positive results," comments Dr. Zivko Nikolov, ProdiGene's Vice President of BioProcess Development and Production, "All of these studies have demonstrated TrypZean(TM) behaves equivalent and in some applications superior to bovine or porcine trypsin."

About ProdiGene

ProdiGene, headquartered in College Station, Texas, is a private biotechnology company that is developing and manufacturing industrial and pharmaceutical proteins from the Company's proprietary transgenic plant system. ProdiGene, as the first and only company to produce and market recombinant proteins from transgenic plants, is well positioned to capitalize on the opportunities in the large and expanding recombinant protein markets. 

About Sigma-Aldrich

Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and chemical manufacturing. It has customers in life science companies, university and government institutions, hospitals and in industry. Sigma-Aldrich operates in 34 countries and has over 6,000 employees providing excellent service worldwide. Sigma-Aldrich is committed to the success of its customers, employees and shareholders through leadership in Life Science, High Technology and Service. 

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