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Interim announcement: MOLOGEN AG : Publication of an interim announcement acc. to §37x WpHG (the German Securities Trading Act) |
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MOLOGEN AG / Interim announcement: MOLOGEN AG publishes results for
the first nine months of 2008 and
gives an overview of R&D activities
Publication of an interim announcement acc. to §37x WpHG (the German
Securities Trading Act) processed and transmitted by Hugin. The
issuer is solely responsible for the content of this announcement.
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- Increased focus on product development raises the company profile
- Important advances in clinical tests with cancer therapy MGN1703
- Promising activities for the expansion of the product pipeline
- Results development on schedule
Berlin, 13 November 2008 - The Berlin-based Biotech company, MOLOGEN
AG, significantly raised its company profile in the first nine months
of the 2008 fiscal year with increased focus on the development of
its own product candidates.
By focussing on clinical development of its own patented therapy
approaches for diseases that require a high level of medical
treatment, the company is set to significantly increase its value.
Positive clinical data strengthen the negotiating position with
regard to potential licensees and allow for attractive licence
conditions.
Important advances in clinical tests with cancer drug MGN1703
Important steps have been made in the current clinical study (phase
I) to investigate the safety, compatibility and immunological effect
of MGN1703 in the treatment of various cancers. The study has been
very promising to date. Subject to a further scheduled study, MOLOGEN
expects to complete the clinical tests in the first quarter of 2009.
At present, an application is being prepared for subsequent clinical
studies of phase II in order to investigate the efficacy of MGN1703.
Promising activities for expansion of the product pipeline
Further milestones in the expansion of the product pipeline are
expected to be reached before the end of the current fiscal year.
Pre-clinical development work for the preparations of a clinical
study with cell-based gene therapy against renal cell cancer
(MGN1601) is almost complete. Plans for an approval-related phase
I/II study with MGN1601 are already in the advanced stages.
Furthermore Mologen could announce recently that the Russian patent
office is going to grant the patent for cell based gene therapy
against cancer.
The EMEA has assigned MGN1601 Orphan Drug Status. Orphan Drug Status
secures a 10-year commercialisation exclusivity within the European
Union. Furthermore, during the licensing procedure the company is
granted the advice and support of the EMEA.
As part of the development of a prophylactic and therapeutic DNA
immunization against visceral leishmaniasis, a serious, often fatal
infectious disease, MOLOGEN is in advanced negotiations for the
guarantee of subsidies by the European Union.
In the first quarter of 2008, a corresponding grant application to
the 7th EU Framework Programme, which MOLOGEN submitted together with
an international consortium, has been reviewed with maximum possible
score. The project was awarded the perfect grade after assessment
through international scientific experts.
Results development on schedule
The results development of MOLOGEN AG ran as scheduled in the first
nine months of the 2008 fiscal year.
Important figures for the period from 1 January to 30 September 2008
according to IFRS (unaudited, comparative period of previous year: 1
Jan to 30 Sep 2007, unaudited):
Operating result (EBIT) for the period EUR -4.8 million (previous
year: EUR -4.4 million). Net loss for the period EUR -4.6 million
(previous year: EUR -4.2 million). Revenues EUR 0.1 million (previous
year: EUR 0.1 million). Other operating expenses EUR -1.6 million
(previous year: EUR -1.7 million). Other operating income EUR 0.0
million (previous year: EUR 0.7 million). Cash funds EUR 4.3 million
(31 Dec 2007: EUR 8.0 million). Equity ratio 92% (31 Dec 2007: 93%).
The result's figures are influenced by high expenditure as part of
the MOLOGEN AG research and development programme. Compared to the
previous period however, the overall expenditure fell by approx. EUR
0.2 million despite rising R&D costs.
Commenting on the business development of the first nine months of
2008, Dr Matthias Schroff, CEO of MOLOGEN AG, said: "Our focus on the
essential pipeline projects has paid off. In the last few months we
have been able to make important progress in this area and intend to
reach further milestones before the end of the year."
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. MOLOGEN
plans to establish an effective, compatible treatment for the
treatment of the most frequent cancers in the form of MGN1703. The
study is performed at the renowned cancer centers in university
hospitals in Essen and Cologne, and will last around six months.
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
to protect against tumor-associated antigens by targeting the TLR9
receptor on certain immune cells. As a result of chemotherapy and
radiotherapy, tumor-associated antigens are released by cancer cells.
The immune system activated by dSLIM® is in a position to overcome
its fatal tolerance towards cancer cells and advance against them
strategically.
Market for immunomodulatory therapies worth billions
In terms of efficacy and compatibility, immunomodulatory therapies
could mean a real medical breakthrough in the fight against cancer.
Experts estimate that there is a global market worth billions of US
Dollars for such therapies.
Pharmaceutical companies are therefore extremely interested in
securing the rights to molecules like TLR9 agonist and testing
substances in many different indications. The recent acquisition of a
US competitor by a globally operating pharmaceutical group is
convincing proof of the great potential attributed internationally to
TLR technology.
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 platform technologies 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
--- End of Message ---
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; Copyright © Hugin AS 2008. All rights reserved.
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