Collaboration Focuses On Development and Global Commercialization of a Molecular Diagnostic Test for the Early Detection of Colorectal Cancer * Abbott obtains non-exclusive worldwide rights to Epigenomics' proprietary DNA methylation biomarker Septin 9 * Anticipate European market launch in 2009; filing for U.S. approval in 2010 * Epigenomics to receive an up-front fee, milestone payments and royalties * Option to expand partnership on multiple Epigenomics biomarkers to other cancer indications
BERLIN and SEATTLE, Sept. 26, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX) (ISIN:DE000A0BVT96) has signed today a non-exclusive strategic collaboration and license agreement in molecular diagnostics with Abbott, a global healthcare company. Under the agreement, Abbott and Epigenomics intend to develop an in vitro diagnostic blood test for the early detection of colorectal cancer based on Epigenomics' proprietary DNA methylation biomarker Septin 9.
The companies anticipate launching a CE-marked test in Europe in 2009 followed by regulatory filing for U.S. approval in 2010. Under the terms of the agreement, Epigenomics will receive an up-front fee, milestone payments and royalties on product sales.
The agreement also contains provisions for the evaluation by Abbott of some of Epigenomics' other proprietary biomarkers for additional cancer indications.
End of Ad hoc
"We are very excited about the agreed partnership with Abbott, one of the global industry leaders in molecular diagnostics. This agreement is an important step towards the commercialization of our key value driver, the blood-based colorectal cancer test. It validates the clinical utility and the commercial attractiveness of this test as well as our revised non-exclusive partnering strategy and creates a potential route to market for our entire early cancer detection franchise," commented Geert Nygaard, Chief Executive Officer of Epigenomics.
The colorectal cancer test will represent the first cancer diagnostic in the growing menu of assays on Abbott's automated m2000 instrument, which is gaining strong acceptance in molecular diagnostics laboratories throughout the world. Abbott will conduct clinical trials and seek regulatory approval worldwide.
Conference Call
The management of Epigenomics will host a conference call at 9 am EST / 3 pm CET today to provide further details and answer questions by investors, analysts, and media. The dial-in numbers for the conference call are:
Dial-in number (within Germany): +49 (0) 6958 999 0805
Dial-in number (U.S. and outside Germany): +1-480-293-1744
Participants are kindly requested to dial in 10 minutes prior to the start of the call.
A recording of the conference call will be provided on Epigenomics' website subsequently: http://www.epigenomics.com/en/down_loads/corporate_material/
About Colorectal Cancer Testing and the Septin 9 Biomarker
Colorectal cancer is the second leading cause of cancer related death. With a cure rate of over 90 percent if diagnosed in early stages, early detection through testing would be valuable. This type of test targets almost 300 million people in Europe, the U.S., and Japan, a market that, in our opinion, is worth more than US$3 billion in total. The gold standard screening test is colonoscopy, an invasive procedure, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is not widely used at short intervals. A non-invasive first-line test therefore would be useful to screen individuals at risk so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the fecal occult blood testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low (approximately 16 percent in the United States). The introduction of a more convenient, patient-friendly test could potentially increase the number of individuals tested. If positive, the patients would be followed up by colonoscopy. This could increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer.
Epigenomics' technology sensitively detects DNA based on specific DNA methylation patterns in blood plasma samples or other body fluids. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with about 3,000 blood plasma samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer.
About DNA methylation
DNA methylation is a tightly controlled biological process that fundamentally affects gene expression and genome stability. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity. Every cell type has its unique DNA methylation "fingerprint" that changes in various normal biological processes and in many diseases, in particular cancer. In our opinion, DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.
About Epigenomics AG
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests can potentially diagnose cancer at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:
The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains a validated biomarker panel 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 body fluids. Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.
As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe.
Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 190 patent families (granted patents and patent applications) through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics' website at www.epigenomics.com.
Epigenomics' 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.