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Epigenomics AG

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

Berlin, Germany, and Seattle, WA, USA, May 13, 2009 (euro adhoc) -

Patents cover biomarker mPITX2 for prostate and breast cancer 
indications
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
new product/molecular diagnostics
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

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
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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