Regulatory authority's notification shortens preparation period for dSLIM clinical studies

MOLOGEN AG (ISIN DE0006637200) has received a confirmation from the responsible regulatory authority, that the production of DNA based immunomodulator dSLIM does not require a manufacturing authorization according to the German pharmaceutical law (Arzneimittelgesetz). Moreover dSLIM does not fall under German gene technology law (Gentechnikgesetz).

Therewith MOLOGEN can produce dSLIM under "Good Manufacturing Practice", GMP guidelines and under its own Quality Assurance.

With this notification the preparation period for dSLIM clinical studies is considerably shortened in formal and temporal terms.

About MOLOGEN

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.

back to the overview