ProBioGen announces exclusive licensing agreement for its proprietary avian cell line AGE1.CR

Berlin, Germany, 12 December 2007

ProBioGen AG, a leading biotechnology company in vertebrate cell engineering and cell culture, today announced that Dr Christoph Giese, Head of ProBioGen's department Cell and Tissue Services, has been granted the 26th Animal Protection Award by Germany's Federal Ministry of Food, Agriculture and Consumer Protection. The award is endowed with 15,000 Euros and granted for innovative methods aiming at a reduction or replacement of animal tests. This year’s prize was jointly awarded to Dr Giese and Dr Ellen Fritsche of the Institute of Environmental Medicine at Heinrich-Heine University in Düsseldorf. By sponsoring this award, the ministry is promoting scientific activities which support the advancement of pharmacological-toxicological methods.

The federal ministry awarded Dr. Giese's pivotal contribution to the development of a novel technology which can be used to reliably assess human immune reactions against a given chemical substance prior to its use in humans. The four-year scientific program was sponsored by the Federal Ministry of Education and Science (BMBF) and led to the development of a bioreactor system which emulates immunological functions of human lymph nodes (Artifical Lymph Node Technology, ALN). A European patent was granted recently, further supporting the innovative leadership of the technology. First contracts for the commercial application of the bioreactor system have already been closed by ProBioGen.

"This award confirms our team’s innovative strength," states Dr Uwe Marx, Chief Scientific Officer at ProBioGen. "By enabling the assessment of immune reactions in a fully human system, we can address an unresolved and serious problem of the biopharmaceutical industry. Not only do we circumvent the limitations associated with the use of animal models, we can also assess the desired and undesired immunogenicity in a human system based on more than just isolated human immune cells. With our artificial lymph node (ALN) technology, we are enabling our customers to run a more efficient drug development process."

About AGE1.CR

AGE1.CR has been developed by ProBioGen in cooperation with IDT Biologika GmbH to replace embryonated chicken eggs and chicken embryonic fibroblasts as substrates for production of human and animal vaccines. Primary chicken material has many disadvantages: It must be isolated freshly from specific pathogen free (SPF) flocks for each manufacturing run. Adventitous agents in the source material often are detected only after completion of the manufacturing process. The production process is complex and usually requires fetal calf serum. Pharmaceutical grade calf serum and SPF chicken are expensive and supply of the latter may become limited if a large production lot fails and needs to be repeated or if a pathogen does enter a SPF flock.

ProBioGen has developed AGE1.CR, a designed stable cell line derived from specific tissue of a single duck embryo. This established cell line fully supports the production of a wide spectrum of important wild-type and recombinant viruses, including highly attenuated poxviruses and members of the orthomyxoviridae, rhabdoviridae, togaviridae, herpesviridae, paramyxoviridae, adenoviridae, and parvoviridae. In contrast to chicken cells, the AGE1.CR cell line from muscovy duck has no retrovirus activity. Complete passage history, development in a dedicated GMP suite and exhaustive testing provide a strong background for application of AGE1.CR as a producer cell line for human and animal vaccines.

About Influenza

Influenza is a highly infectious disease, which affects 10–20% of the global population every year, causing up to 500,000 deaths per annum. Collective sales of influenza vaccines from Western manufacturers surpassed the $1 billion level in 2004 with 10% growth over the previous year. It is estimated that up to 15% of future capacities for influenza vaccine production could originate from new manufacturing technologies like ProBioGen's novel cell line. According to Datamonitor forecasts, demand for influenza vaccines in major markets will expand to 370 million doses and a market value of $3.7 billion by 2010.

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