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Ad-hoc-Release; September 22, 2005


MOLOGEN receives manufacturing authorisation

for a DNA vaccine


MOLOGEN AG (ISIN DE0006637200) has received the manufacturing authorisation according to the German pharmaceutical act (Arzneimittelgesetz, AMG) for the agents of its MIDGE® based DNA vaccine against an important infectious disease in animals.

MOLOGEN successfully scaled up its production process following GMP (Good Manufacturing Practise) guidelines and finished the extension process for the Berlin production sites, which had been started in 2004.
The agents, which are produced in compliance with GMP standards, are permitted to be used in and sold for clinical studies in the future. The increased production capacities are able to meet the requirements in quality and quantity for compounds for clinical studies and for the authorisation process for vaccines. This ability is the precondition for the intended licensing of the vaccine.



MOLOGEN uses its proprietary DNA technologies to create and develop treatments for high-unmet-need illnesses. The main focuses are the unique and patented MIDGE and dSLIM technologies. Based on these platforms, MOLOGEN is developing DNA-based vaccines and therapeutics to prevent or cure a wide range of diseases.

Going public in 1998, MOLOGEN was one of the first German biotechnology companies to be floated on the stock exchange. The MOLOGEN shares are traded on the Geregelter Markt in Frankfurt.


Disclaimer concerning prognoses

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.


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Investor & Public Relations

  Joerg Petrass

Research & Development

  Dr. Matthias Schroff

Business Development

  Arlett Killat


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