EANS-News: Epigenomics AG Receives Allowances for Key Patents in Europe

Patents cover biomarker mPITX2 for prostate and breast cancer
indications

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new product/molecular diagnostics

Berlin, Germany, and Seattle, WA, USA, May 13, 2009 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular
diagnostics company focusing on the development and commercialization
of products for cancer detection based on DNA methylation, today
announced that it has received Rule 71(3) notifications stating that
the European Patent Office intends to grant two patent for
Epigenomics' PITX2 DNA methylation biomarker (mPITX2). This
notification is equivalent to a "Notice of Allowance" by the United
States Patent and Trademark Office. Patent application EP1831399,
covers very broadly the use of Epigenomics' mPITX2 biomarker in the
prognosis of prostate cancer. The second patent application EP1554407
covers the use of mPITX2 in the prediction of the response of breast
cancer patients to adjuvant antihormonal therapy. Equivalent patent
applications are also pending in the USA, Japan, Australia and
Canada.

The mPITX2 biomarker is at the core of Epigenomics' prostate cancer
prognosis test that indicates the risk of early disease recurrence
following a surgical removal of the cancerous prostate. In October
2008, Epigenomics successfully validated the biomarker using a fully
developed test system for this application. The results of this
biomarker validation study were presented by Lionel L Bañez, MD at
Duke University, during the plenary session of the 2009 Annual
Meeting of the American Urological Association in Chicago last month
generating lots of attention within the urology community.

"Assessing PITX2 methylation could provide a valuable means to better
define prostate cancer risk groups and thus aid in selection of
patients for whom adjuvant and/or early salvage therapy may be
warranted," commented Dr. Bañez. "Furthermore, PITX2 methylation
status could also be used in the rational design of clinical trials
and improve testing of new therapeutic regimens."

Dr. Bañez, who is affiliated with the Division of Urologic Surgery
and the Duke Prostate Center at Duke University Medical Center in
Durham, North Carolina, presented the results on behalf of the
collaborators at the clinical sites participating in this
international multicenter study also including the Baylor College of
Medicine, Houston, Texas, USA, the Erasmus Medical Center, Rotterdam,
The Netherlands, the VA Medical Center at Durham, North Carolina,
USA, and the University Hospital Erlangen, Erlangen, Germany.

Epigenomics has now initiated an "Early Access Program" with selected
clinical centers in Europe and aims at making PITX2 methylation
testing available in the first half of 2009 while negotiating with
potential partners for broader diagnostic commercialization rights.

Earlier studies by Epigenomics and its clinical collaborators had
shown that the mPITX2 biomarker may also be useful to predict the
likelihood of relapse in patients treated for breast cancer.

Following the receipt of the patent allowance Geert Nygaard,
Epigenomics' Chief Executive Officer, commented: "These patents add a
strong layer of protection to our cancer diagnostics franchise. We
now have granted patents covering biomarkers in our colorectal cancer
screening business such as mSEPT9, as well as prostate cancer testing
with mPITX2 allowed in Europe and mGSTP1 granted in the US already.
This strong patent position for diagnostic content is at the heart of
our business model and we leverage this asset in high value deals
with pharmaceutical and diagnostic partners as well as direct
commercialization in certain market segments."

Dr. Uwe Staub, Senior Vice President of Product Development at
Epigenomics added: "Patent protection for our prognostic prostate
cancer test covers DNA methylation specific sample preparation,
biomarker detection technologies and also the core of our product,
the mPITX2 biomarker. The mPITX2 test has repeatedly confirmed its
clinical utility in stratifying patients with regard to
aggressiveness of their cancer and risk of relapse. The mPITX2 patent
is one of several dozen biomarker patent applications we filed over
the past several years covering hundreds of proprietary DNA
methylation biomarkers in many cancer indications many of which hold
similar potential to mSept9 and mPITX2. This patent portfolio
underscores our leading position in molecular diagnostics based on
DNA methylation."

About Epigenomics' Prostate Cancer Prognosis Test

Prostate cancer is the most common cancer in American and European
men. With an annual incidence of approximately 470,000 cases in the
US and Europe, one in six men will be diagnosed with prostate cancer
in his lifetime and about 100,000 men will die from the disease every
year. Surgical removal of the prostate (radical prostatectomy) is
performed as potentially curative treatment in about 40% of patients
diagnosed with prostate cancer. Nevertheless, the disease recurs in
about one in seven prostatectomy patients. However, the difficulty
clinicians have is that even with the use of current prognostic
parameters, there still remains considerable uncertainty concerning
which patients will eventually relapse. Epigenomics is developing a
prostate cancer molecular classification test based on the DNA
methylation biomarker PITX2 (mPITX2) that will provide physicians and
patients with prognostic information on disease recurrence by
identifying those prostatectomy patients at increased risk.

Currently, prognostic information is mainly derived from clinical and
histopathological parameters, such as tumor size, tumor margin
status, Gleason Score and pre-surgery PSA levels. In a two
independent studies in 2006 and 2008, Epigenomics has shown that DNA
methylation of the PITX2 Gene constitutes a strong prognostic marker
for outcome prediction after radical prostatectomy. mPITX2 separates
post-prostatectomy cancer patients into two distinct groups: Those
with a high likelihood of cancer recurrence and those with a low
likelihood of cancer recurrence. Furthermore, the mPITX2 status adds
significant information to established clinical parameters.
Remarkably, the mPITX2 biomarker is able to predict outcome in
patients diagnosed with Gleason 7, for which reliable prognosis based
on conventional parameters is particularly difficult. The demand
among physicians for such a molecular diagnostic test is high, since
it identifies patients with a poor prognosis that are possibly
under-treated. Epigenomics will make mPITX2 available at selected
clinical centers in Europe.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation
biomarkers, Epigenomics' tests in development aim at diagnosing
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.

Epigenomics' product pipeline contains a validated biomarker for the
early detection of colorectal cancer in blood plasma, and further
proprietary DNA methylation biomarkers at various stages of
development for prostate and lung cancer detection in urine, blood
and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the
early detection of colorectal cancer in a simple blood sample
demonstrated continuously highest performance in multiple clinical
studies with in total about 3,500 individuals tested. A large
prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a
screening population is currently under way (www.presept.net).

For development and global commercialization of in vitro diagnostic
test products, Epigenomics pursues a non-exclusive partnering
strategy. Strategic diagnostics industry partners include Abbott
Molecular, Philips, Sysmex Corporation and Quest Diagnostics
Incorporated for diagnostics test products and services, and QIAGEN
N.V. for sample preparation solutions and research products.

Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers protected by more than 150
patent families through research products, Biomarker Services, IVD
Development Collaborations, and Licensing. The company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary
in Seattle, WA, U.S.A. For more information, please visit
Epigenomics' website at www.epigenomics.com.

Epigenomics legal disclaimer. This communication expressly or
implicitly contains certain forward-looking statements concerning
Epigenomics AG and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors which could
cause the actual results, financial condition, performance or
achievements of Epigenomics AG to be materially different from any
future results, performance or achievements expressed or implied by
such forward-looking statements. Epigenomics AG is providing this
communication as of this date and does not undertake to update any
forward- looking statements contained herein as a result of new
information, future events or otherwise.

end of announcement euro adhoc
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Epigenomics AG

Dr. Achim Plum

Sen. VP Corporate Development

Tel: +49 30 24345 368

achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technologie All Share
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Berlin / free trade
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