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MediGene AG presents future business plan at annual analyst
conference |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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Martinsried/München, December 15, 2009. MediGene AG (Frankfurt: MDG,
Prime Standard, TecDAX) presented the company's future strategic
plans through 2015 at its annual analyst conference in Frankfurt. As
part of the presentations, the company announced that it will
continue to sharpen its business focus and outlined the future
development plans for the drug candidates EndoTAG(TM)-1 and
RhuDex(TM) in detail. Sustained profitability of the company is
expected to be secured by product revenues with the launch of
EndoTAG(TM)-1 from 2015.
Dr. Frank Mathias, Chief Executive Officer of MediGene AG commented:
"Over the last several months the new management team has analyzed
the current status of the company, evaluated both benefit and risk,
and based on that analysis, has defined a number of new strategic
goals and measures. With this five-year plan, we will seek to
minimize the development risks of our pipeline, optimize the value of
our most important drug projects, improve the company structure and
lead MediGene to a financially independent future."
The most important strategic and operational steps for 2010-2015 will
be a step-wise focus on the field of oncology, the closing of a
partnership for the cancer drug EndoTAG(TM)-1 during 2010, the
finalization of the ongoing phase II study with EndoTAG(TM)-1 for the
treatment of breast cancer in the first half of 2010 and the start of
a phase III study with EndoTAG(TM)-1 for the treatment of pancreatic
cancer (together with a partner) in the first half of 2011. In the
context of greater focus, RhuDex(TM) for the treatment of rheumatoid
arthritis will be prepared for out-licensing and all other
technologies that are deemed non-core shall be spun off or sold.
To improve the value of the development project EndoTAG(TM)-1, the
freeze drying manufacturing process that is currently in place will
be converted to a spray drying process before the start of the phase
III study, which is planned to start in the first half of 2011. This
will significantly improve the future EndoTAG(TM)-1 cost of goods.
Moreover, the results of the phase II breast cancer study, which are
expected for the first half of 2010, will deliver a second proof of
concept for the drug candidate. Dr. Mathias indicated that no
decision has yet been made on whether the intended partnership will
be closed before or after the presentation of the phase II breast
cancer data, which could significantly increase the value of the
product.
For the drug candidate RhuDex(TM), the new development plan provides
for further preclinical studies during 2010 in order to more
accurately specify the therapeutic window and thus optimizing the
clinical development program. Clinical development is expected to be
resumed in the fourth quarter of 2010 or in the first quarter of 2011
and MediGene intends to out-license the immunological drug candidate
once clinical proof of concept has been achieved, if not before.
Besides RhuDex(TM), MediGene will aim at out licensing or spinning
off the oHSV and AAVLP technologies to realize the desired focus on
oncology and clinical development. Similar to the spin out of the
mTCR technology which has already taken place, MediGene will seek to
retain future access to promising drug candidates in any transaction.
In order to extend its pipeline, MediGene AG is planning to develop
new candidates from its EndoTAG(TM) technology platform and hence to
concentrate on liposome technology, its core competence within
oncology. At a later point in time, it may be possible that
in-licensing of oncology products will extend the portfolio, and
MediGene intends to bring two further products into the clinical
development pipeline by 2015.
By 2015 MediGene plans to have three products on the market,
including EndoTAG(TM)-1 for pancreatic cancer, which the company will
seek to co-market with a partner. In addition, MediGene expects to
have one new drug candidate in development stemming from the
EndoTAG(TM) technology as well as any in-licensed products. The
market launch of EndoTAG(TM)-1 in 2015 will take MediGene into
sustained profitability for the first time, but until that time
product revenues, payments from partnerships and tight cost
management will contribute to the company's financial stability.
At the analyst conference, MediGene confirmed its revenue forecast
for the business year 2009 of approximately 40 million euro and
further specified the forecast on an EBITDA basis to be a loss of
approximately 20 million euro (last forecast: -20 to -23 million
euro). In the full year 2008, MediGene realized total revenues of
39.6 million euro and an EBITDA loss of -24.6 million euro.
The presentation of the analyst conference can be found in the
internet at www.medigene.com.
This press release contains forward-looking statements representing
the opinion of MediGene as of the date of this release. The actual
results achieved by MediGene may differ significantly from the
statements made herein. MediGene is not bound to update any of these
forward-looking statements. MediGene® and EndoTAG(TM) are registered
trademarks of MediGene AG. RhuDex(TM) is a registered trademark of
MediGene Ltd. These trademarks may be owned or licensed in select
locations only.
- ends -
MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,
TecDax) biotechnology company located in Martinsried/Munich, Germany,
Oxford, UK, and San Diego, USA. MediGene is the first German biotech
company to have drugs on the market, which are distributed by partner
companies. MediGene has several drug candidates in clinical
development, two of which provide significant sales potential. In
addition, the company pursues several development projects and
possesses innovative platform technologies for drug development.
MediGene focuses on clinical research and development of novel drugs
for the treatment of cancer and autoimmune diseases.
Contact MediGene AG
E-mail: investor@medigene.com
Fax:++49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 - 89 -
85 65 - 3324
Dr. Georg Dönges, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946
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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN:
502090; ISIN: DE0005020903 ;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Bayerische Börse München,
Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr
in Niedersächsische Börse zu Hannover,
Regulierter Markt in Frankfurter Wertpapierbörse; Copyright © Hugin AS 2009. All rights reserved.
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