MOLOGEN AG: Expanded manufacturing authorisation for MIDGE®-based active substances

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The Berlin biotech company MOLOGEN AG has received a significantly
expanded manufacturing authorisation for its MIDGE®-based DNA active
substances.

After detailed inspections, the responsible authorities have
confirmed that the production and quality of the active substances
meets the requirements of the German Medicinal Products Act (AMG) and
the GMP guidelines (GMP: Good Manufacturing Practice). The
manufacturing authorisation is no longer linked to individual active
substances, but applies generally to the MIDGE® production process.

New active substances must merely be reported to the authorities. A
separate, very time-intensive application for individual active
substances is no longer required. The active substances which are
produced for clinical trial products may be used in clinical studies
up to and including Phase II.

The manufacturing authorisation marks the successful completion of
process optimisations with the objective of being able to produce
sufficient quantities of DNA active substances for clinical studies
in the required quality itself.

The production process for dSLIM®-based active substances as they are
currently being used in the clinical trial Phase I with MGN1703 was
also inspected in detail in the course of the inspection process.
Here as well, compliance with the AMG and the GMP guidelines in
production and quality was confirmed.

The granting of the general manufacturing authorisation documents the
extensive know-how of MOLOGEN in handling DNA-based active
substances.

MOLOGEN AG with its clinical development programs for DNA
pharmaceuticals is among the leading biotechnology companies in the
field of DNA medicine.

''We have attained an important goal with the granting of the
expanded manufacturing authorisation. We can now ourselves produce
the DNA active substances that are required for our clinical
development programs in the required quality and amounts'', Dr.
Matthias Schroff, CEO of MOLOGEN AG, explained.

Information about the clinical study with MGN1703
The study (Phase I) of the safety, compatibility and immunological
effect of MGN1703 in the treatment of various cancers is a major
milestone for a comprehensive clinical development program. The study
is currently performed at the renowned cancer centers in university
hospitals in Essen and Cologne. MOLOGEN plans to establish an
effective, compatible treatment for the treatment of the most
frequent cancers in the form of MGN1703.

dSLIM® - an innovative TLR9 agonist
In dSLIM® ("double Stem Loop Immunomodulator"), MOLOGEN has developed
an innovative TLR9 agonist. Use of dSLIM® activates the immune system
against tumor-associated antigens by targeting the different
receptors, primarily TLR9, on certain immune cells. As a result of
chemotherapy and radiotherapy, tumor-associated antigens (TAA) are
released by cancer cells. The immune system activated by dSLIM® is in
a position to overcome its fatal tolerance towards cancer cells and
TAA and advance against them strategically.

MIDGE® - the basis for novel DNA vaccines
In biotechnology, delivery vehicles for the transmission of nucleic
acids (primarily DNA) are called vectors. The MIDGE® (Minimalistic
Immunogenically Defined Gene Expression) technology developed by
MOLOGEN is also described as a DNA vector. In contrast to other DNA
vectors (plasmids, viruses), the MIDGE® vector only contains the
information necessary for the actual action. It is free of
undesirable structures that are only used for the manufacturing
process.
MIDGE® created the basis for a broad spectrum of modern DNA-based
applications. These vectors are designed with a variety of
individualized properties and are exceptionally well suited for
DNA-based vaccination against infectious diseases like Leishmaniasis.

About MOLOGEN
MOLOGEN AG, a biopharmaceutical company based in Berlin, specializes
in the research and development of innovative medicines based on DNA
structures (DNA: deoxyribonucleic acid).
Its patented DNA-based technology platforms MIDGE® and dSLIM® form a
universal foundation with a wide range of possible applications.
Activities focus on product developments for the treatment of cancer
and vaccines for serious infections in humans and animals.
MOLOGEN was founded in 1998 and was the first German biotechnology
company to go public. MOLOGEN AG shares are listed in the General
Standard of Deutsche Börse (ISIN DE 0006637200).

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.

MOLOGEN AG
Fabeckstr. 30, 14195 Berlin, Germany
Contact: Joerg Petrass
Email: investor@mologen.com
Phone: +49-30-84 17 88-13
Fax: +49-30-84 17 88-50

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MOLOGEN AG
Fabeckstr. 30 Berlin Germany

WKN: 663720; ISIN:
DE0006637200;
Listed: Freiverkehr in Börse Berlin, Freiverkehr in Hanseatische
Wertpapierbörse zu Hamburg,
General Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Bayerische Börse München,
Freiverkehr in Börse Stuttgart;
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