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Drug production in transgenic plants - Icon Genetics and Berlex join strategic alliance

Munich, Germany
August 17, 2004 

Icon Genetics AG announced that it has entered into a collaborative agreement with Berlex, the US affiliate of Schering AG Germany (NYSE:SHR). The companies will evaluate the expression levels and quality of selected Berlex pre-clinical pharmaceutical proteins when expressed in transgenic plants using Icon's proprietary magnICON® biomanufacturing platform technology. Financial details of the agreement were not disclosed.

Icon Genetics' magnICON® biomanufacturing platform technology provides a method for producing therapeutic and other high-value recombinant proteins using non-GMO (genetically modified organisms) non-food plants as a production host. The technology provides for the extraordinary amplification level of the gene of interest and simultaneous shut-off of the other biosynthetic processes in the cell, resulting in the highest theoretically possible yield and relative yield of a recombinant protein in a plant cell. The magnICON® technology also allows for rapid (weeks) production of gram quantities of recombinant proteins necessary for clinical trials, thus eliminating the major R&D bottleneck.

"We welcome this relationship with Berlex," said Yuri Gleba, CEO of Icon Genetics. "This collaboration is expected to provide additional validation for our unique biomanufacturing technology, creating solid product development and manufacturing opportunities."

"Berlex together with its German parent company possesses more than 100 years of pharmaceutical manufacturing experience and a demonstrated expertise in developing novel biopharmaceuticals," said Eirik Nestaas, PhD, vice president responsible for process development and clinical production of biopharmaceuticals at Berlex. "For several reasons it is important for us to evaluate new manufacturing platforms, such as transgenic plants, at an early stage. Such technologies may benefit drug development by accelerating entry into clinical trials as well as facilitating scale-up to commercial production. Furthermore, they may potentially allow us to successfully address unmet medical needs through novel biopharmaceuticals that cannot otherwise be readily provided."

Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex, Inc., a US affiliate of Schering AG, Germany (NYSE: SHR), develops and markets diagnostic imaging agents, treatments in the areas of female healthcare and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems, oncology, and gastroenterology. Berlex has business operations in New Jersey, California and Washington.

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