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13.05.2009 – 10:01

Epigenomics AG

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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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 (

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

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

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