Boehringer Ingelheim And GENEART Collaborate On Offering Design And Production Services For DNA Therapeutics And Vaccines

Boehringer Ingelheim And GENEART Collaborate On Offering Design And Production Services For DNA Therapeutics And Vaccines

Geneart AG - The collaboration offers customers an integrated system solution from the design to the production of DNA-based pharmaceutical agents for clinical trials and the global market - GENEART will cover the gene optimization and the production of pharmaceutical agents in the form of plasmids for research and preclinical use - Boehringer Ingelheim will produce plasmids for the subsequent clinical trials and the global market - The transfer of Boehringer Ingelheim technology to GENEART assures the consistent quality of the pharmaceutical agents through all development phases - The collaboration is a response to the growing market for DNA-based therapeutics and vaccines

Regensburg, June 24, 2008 - Today, Boehringer Ingelheim, one of the global leaders in the production of plasmid DNA, and GENEART, global leader in the design and synthesis of genes, announce their technology and sales collaboration. The collaboration includes a transfer of Boehringer Ingelheim technology to GENEART for the production and purification of plasmid DNA. The two partner companies also plan to closely collaborate in the distribution and marketing of their complementary services.

The collaboration offers a unique system solution for the development of DNA-based pharmaceuticals. GENEART will use the Boehringer Ingelheim production and purification technology to deliver DNA-based agents for research, development and preclinical studies. Boehringer Ingelheim will produce the pharmaceuticals under cGMP (current Good Manufacturing Practice) conditions for the subsequent clinical phases and the market. Customers in research and industry additionally benefit from GENEART's expertise in software-assisted design of gene sequences and from the production of these improved (optimized) sequences via gene synthesis. Optimized genes are essential for the improvement of product properties, such as for the enhancement of immunogenicity and safety of DNA based pharmaceuticals.

Professor Dr. Ralf Wagner, CEO of the GENEART AG, comments: "The collaboration with Boehringer Ingelheim opens new horizons to support customer projects in the fast growing market for DNA-based therapeutics and vaccines. Optimized pharmaceutical agents will be readily available in consistent quality for every development phase either from GENEART or from Boehringer Ingelheim, respectively. This also applies to the necessary quantities for clinical trials or for the product launch. Thus, this collaboration ideally meets the requirements of the regulatory agencies for a consistent source of pharmaceutical agents for the entire development process. Therefore, our customers can avoid unnecessary and expensive delays caused by repeated studies to prove consistent agent quality."

Professor Dr. Dr. h.c. Rolf G. Werner, Senior Vice President of the Boehringer Ingelheim GmbH Corporate Division Biopharmaceuticals, elaborates: "GENEART perfectly complements our services for the development and production of plasmid-DNA for use in clinical trials and for the market. The transfer of technology from Boehringer Ingelheim to GENEART offers flexible access to optimized DNA agents and the benefit of an economic production technology to a broad clientele in R&D. The consistent production procedures help our customers to significantly shorten the time to market for new innovative DNA-based therapeutics and vaccines."

For further inquiries, please contact:

Bernd Merkl GENEART AG Josef-Engert-Str. 11 93053 Regensburg Germany Phone: +49-(0)941-942 76-638 Fax: +49-(0)941-942 76-711 [email protected] www.geneart.com

Frank Ostermair Better Orange IR & HV AG Haidelweg 48 81241 Munich Germany Phone: +49-(0)89-8896906-10 Fax: +49-(0)89-8896906-66 [email protected] www.better-orange.de

Legal Information This document may contain estimates, prognoses and opinions about company plans and objectives, products or services, future results, opinions about these results or opinions leading up to these results. All these projections into the future are subject to risk, uncertainty and unforeseeable change outside the control of the GENEART Group. Many factors may lead to actual results, which considerably deviate from the given projections for these results.

About GENEART AG In 2000, GENEART entered the gene synthesis market and has since become the global market leader. Today, the company is one of the leading specialists in the Synthetic Biology field. Experts at GENEART provide key technologies for the development and production of new therapeutics and vaccines. Customers also take advantage of GENEART services to customize enzyme attributes, such as the attributes of enzymes used as detergent additives, and to construct bacteria, which produce complex biopolymers or break down polymers, such as synthetics, petroleum components, etc. Our production and service spectrum spans a wide range, from the production of synthetic genes according to DIN EN ISO 9001-2000, to the creation of gene libraries in the combinatorial biology, to the development and production of DNA-based biologically active substances. The GENEART AG in Regensburg (Germany) and the subsidiary GENEART Inc. in Toronto (Canada) employ more than 190 people. Since May 2006, GENEART is listed on the German Stock Exchange.

About Boehringer Ingelheim:

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates and almost 38,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing innovative products of high therapeutic value for human and veterinary medicine. In addition to captive use manufacturing, Boehringer Ingelheim is operating a contract development and industrial customer manufacturing business for Biopharmaceuticals.

For fermentation with E.coli, Boehringer Ingelheim offers high-expression systems. An additional focus is the development and production of products in different yeast systems. The capacity of the available bioreactors is more than 12,000 L. Furthermore, Boehringer Ingelheim has set the standard for manufacturing of plasmid DNA, and today supplies early to late-stage clinical trials for its international clients.

Boehringer Ingelheim has developed a proprietary, highly efficient mammalian expression system for CHO cells in animal component free media. This Boehringer Ingelheim High Expression System (BI HEX®) allows the development and production of high-quality products in a time-to-market approach and on a cost-saving basis. For the mammalian cell culture products a total capacity of 180,000 L is available. .The downstream processing is matched to the scale of the production capacity.

These comprehensive manufacturing technology platforms also include proprietary media and downstream packages for the production of therapeutic biopharmaceutical products. Further technologies include liquid and slow release formulation as well as inhalation devices.

For more information see: http://www.boehringer-ingelheim.com/biopharm [email protected]

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