Wacker Validates Scalability of Anticalin(R) Production With E.coli Secretion Technology and Will Produce Pieris First Clinical Candidate PRS-050

Thursday, July 17, 2008 General News J E 4
FREISING-WEIHENSTEPHAN and JENA, Germany, July 17 PierisAG, a bio-pharmaceutical company developing Anticalins(R), a novel class oftargeted human protein therapeutics, and Wacker Biotech GmbH, a full-servicecontract manufacturer of biopharmaceuticals, announced yesterday asignificant milestone in the development of Pieris' PRS-050 Anticalin(R) forclinical trials.

Pieris has developed PRS-050 as a next generation VEGF antagonist and asthe first Anticalin(R) -based product in its proprietary pipeline. PRS-050exemplifies many of the favourable characteristics of Anticalins(R): compactprotein structure, high intrinsic stability, broad formulation flexibilityand small molecular size improving the likelihood of effective target access.PRS-050 has already demonstrated potent inhibition of VEGF-induced enhancedvascular permeability and angiogenesis, as well as, anti-tumour activity andis expected to enter the clinic in 2009.

Wacker's proprietary E. coli secretion system is a well-establishedtechnology for the cost-efficient production of proteins. At the core of thetechnology is a proprietary E. coli K12-strain, developed by Wacker, tosecrete recombinant proteins in native form. Production of clinicallyrelevant proteins via direct extracellular secretion offers a far more costeffective approach to biopharmaceutical product manufacture than traditionalprotein refolding technologies.

Andreas Hohlbaum Ph.D., Chief Technology Officer of Pieris, stated:"Pieris has long-established expertise in small scale expression ofAnticalins(R) for research use. As we progress our products to the clinic, wehave established through our relationship with Wacker that an efficientproduction scale-up is possible. These excellent results and subsequentagreement with Wacker will expedite process development and GMP manufactureof Anticalins(R) for both proprietary and partnered products."

Thomas Maier Ph.D., Managing Director of Wacker Biotech, commentedfurther: "The Anticalin(R) technology is one of the most exciting 'BeyondAntibody' technologies and we are very proud to support Pieris in its aims todevelop this new class of therapeutic proteins. The results obtained to dateunderscore the power of our E. coli secretion technology and highlight WackerBiotech's commitment to becoming a leading force as a full-service contractmanufacturer of biopharmaceuticals."

More information on Pieris AG is available at

More information on Wacker Biotech GmbH is available at further information, please contact: Pieris AG Andreas Hohlbaum PhD, Chief Technology Officer Phone +49(0)8161-1411-400 Wacker Chemie AG Press and Information Nadine Baumgartl Phone +49(0)89-6-2791-604



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