Medigene expands clinical trial plan for RhuDex® in PBC and updates development timelines

2013-02-04 21:03:26 -

Medigene AG /
Medigene expands clinical trial plan for RhuDex® in PBC and updates development
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Martinsried/Munich, February 4, 2013. Medigene AG (Frankfurt, Prime Standard)
announces that the Executive Board has decided, with the approval of the
Supervisory Board, to expand the clinical development plan for RhuDex(®) in the
treatment of autoimmune diseases. Following recommendations of the regulatory
authorities and the Steering Committee, the planned phase IIa trial in the
indication of primary biliary cirrhosis (PBC) is to be expanded from a three-arm
to a four arm, controlled study and the planned treatment period for patients
will be extended from three to six months. The aim is to increase the
information value of the trial data collected in order to confirm the mode of
action of RhuDex(®) in autoimmune diseases and facilitate the future approval of
RhuDex(®) for PBC. This is expected to further increase the value of the drug
candidate in both scientific and commercial terms.

Medigene will now develop the modified trial design. Subject to the successful
completion of the necessary preparatory work and the approval of the study by
the regulatory authorities, the start of this expanded phase II trial is
scheduled for the first half of 2014 at the latest. It will replace the phase
IIa trial with RhuDex(®) originally planned for 2013. As a result, the major
financial expenses relating to a phase II trial will be deferred to 2014 and
thereafter. On the occasion of the publication of the Company's annual report on
March 22, 2013, Medigene will provide further details of the development
strategy for RhuDex(®) and the Company' s financial outlook.

Dr. Frank Mathias, Chief Executive Officer of Medigene AG explains: "The
expanded trial may deliver findings of a higher quality regarding the clinical
relevance of the mode of action of RhuDex(®) in the treatment of PBC and other
autoimmune diseases, including rheumatoid arthritis. The medical need in PBC is
high, and many patients are urgently awaiting the availability of a specific
treatment regime. If the development is successful, RhuDex(®) may become the
first disease modifying, causal treatment option in this indication."

About RhuDex: Medigene is developing RhuDex(®) as an oral, disease-modifying
drug for the treatment of autoimmune diseases. RhuDex(®) is a CD80 antagonist
that blocks undesired T-cell activation and thus has an immunomodulating and
anti-inflammatory effect. Therefore, this drug candidate can be classified with
the group of "Disease-Modifying Antirheumatic Drugs" (DMARDs). Medigene has
successfully completed a phase IIa pilot study with RhuDex(®) in the indication
rheumatoid arthritis.

About PBC: The autoimmune disease PBC is a chronic liver disease that initially
affects the bile ducts. The bile ducts are progressively destroyed by
inflammatory processes, causing biliary stasis and build-up of bile in the
liver. Liver tissue is destroyed and replaced by connective tissue, liver
cirrhosis develops. As in rheumatoid arthritis, the activation of T cells via a
CD28-CD80 interaction has been described as involved in the pathogenesis of PBC,
a process that is to be inhibited by RhuDex(®) treatment. PBC belongs to the
orphan diseases, i.e. a group of rare and severe medical conditions. Under
certain circumstances, the development, approval and marketing of drugs for the
treatment of orphan diseases are supported by public subsidies.

Medigene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology
company headquartered in Martinsried/Munich, Germany. Medigene focuses on
clinical research and development of novel drugs against cancer and autoimmune
diseases. Medigene was the first German biotech company to have revenues from
marketed products, which are currently distributed by partner companies. The
company has two drug candidates in clinical trials and is developing an
innovative vaccine technology. For more information, please visit

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 forward-looking statements made
herein. Medigene is not bound to update any of these forward-looking statements.
Medigene(®) and Veregen(®) are registered trademarks of Medigene AG. These
trademarks may be owned or licensed in select locations only.

Contact Medigene AG
Julia Hofmann, Claudia Burmester
Investor & Public Relations
Tel.: +49 - 89 - 20 00 33 - 33 01
Fax: +49 - 89 - 20 00 33 - 29 20

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