Epigenomics AG reviews all options for the commercialization of cancer screening test products after end of collaboration with Roche Diagnostics
* Roche Diagnostics notified Epigenomics about the termination of the joint collaboration on screening tests for early detection of cancer and returns licensed marker Septin 9
* Epigenomics announces positive clinical data for colorectal and prostate cancer screening test programs
* New data show the development and commercialization potential of molecular diagnostic test products
Berlin, Germany and Seattle, WA, USA, Friday, 15.12.2006, Epigenomics AG (Frankfurt, Prime Standard: ECX) today announced that Roche Diagnostics has notified the company about the termination of the joint collaboration focusing on the development of a range of molecular diagnostic cancer products. Roche Diagnostics will return all rights and licenses including the first marker, Septin 9, which it had licensed in December 2005. Roche Diagnostics took the decision after the presentation of new clinical data from the colorectal cancer screening test program.
In a prospective study on 561 blood plasma samples, Epigenomics validated that a modified sample processing workflow and a marker panel consisting of Septin 9 and one novel biomarker, improved the detection of early stage (I-III) colorectal cancer with 66% sensitivity and 93% specificity significantly over studies with Septin 9 alone reported in 2005.
In another study in its prostate cancer screening program with Roche, Epigenomics detected prostate cancer with a sensitivity of up to 74% at a specificity of 96% using single proprietary DNA methylation biomarkers on urine samples of prostate cancer patients and healthy individuals.
Epigenomics is convinced that the quality of the new data allows the further development and commercialization of in vitro diagnostic test products for early detection of cancer. Now that Epigenomics has full control over all its product development programs, the company will review all options for a fast commercialization of the cancer screening tests.
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“Our new colorectal cancer screening data clearly exceeds expert’s desired performance target for a product that could address this huge market successfully. We are disappointed about Roche’s decision and strongly disagree with their impression that our data does not support a development decision.,” states Christian Piepenbrock, COO of Epigenomics. “We as Epigenomics believe the performance of our colorectal biomarker panel warrants further development and commercialization to make patients benefit as soon as possible from this urgently needed blood test”.
In September 2002, Epigenomics and Roche entered into a broad collaboration to develop a range of molecular diagnostic cancer products based on Epigenomics’ DNA methylation technologies. The collaboration focused at last on the development of three in vitro diagnostic products for the early detection of colorectal, prostate, and breast cancer.
Epigenomics in all three programs was responsible for biomarker research including discovery, selection and pre-validation of biomarker panels in clinical proof-of-concept studies. At the end of the research phase, Roche Diagnostics had the right to obtain a world wide exclusive license for the prevalidated biomarker panel and a non-exclusive license to Epigenomics’ DNA methylation technology to develop and commercialize in vitro diagnostic test kits for the biomarker panels in the respective applications. Diagnostic test development, pivotal clinical trials, product manufacturing, regulatory submissions and all sales and marketing worldwide were to be conducted by Roche.
Under the terms of the agreement, Roche made an upfront payment of EUR 4 million and in addition provided R&D funding, milestone payments and was to provide royalties on product sales. Since 2002, Epigenomics has met a series of major milestones in this collaboration, which was originally earlier this year extended by 18 months to September 2007.
Today, December 15, 2006, will be a conference call with management at 11am CET. The dial-in numbers will be provided on Epigenomics’ website on time.
The conference call will be recorded and afterwards available at the download section on our website.
Note to editors
Details of the Colorectal Cancer Screening Study
Following the successful validation and subsequent licensing by Roche Diagnostics of Septin 9 as an “anchor” DNA methylation marker in December 2005, Epigenomics continued its research and development efforts to further improve the early detection of colorectal cancer (CRC) in blood.
A panel containing Septin 9 and one additional novel DNA methylation biomarker together with a modified sample processing workflow was finally validated in a clinical study with prospectively collected blood samples of 561 individuals. The study met its goals by demonstrating that early stage colorectal cancers (patients with stage I-III CRC) could be detected with 66% sensitivity at 93% specificity. This is an improvement of 16 percentage points in sensitivity at comparable specificity over the reference study with Septin 9 alone reported in December 2005.
Details of the Prostate Cancer Screening Study
The clinical study was performed on matched plasma and urine samples collected from 91 prostate cancer patients and 100 controls without cancer. Four proprietary candidate biomarkers previously identified on tissue were measured using Epigenomics sensitive DNA methylation assays.
The study met its goals by demonstrating the feasibility of detecting prostate cancer in body fluids and determined that for this cancer urine is the better analyte compared to plasma. All of the four biomarker candidates studied were able to discriminate between prostate cancer and healthy controls with sensitivities of up to 74% in urine compared up to 37% in plasma at a predefined specificity of 96%.
About Colorectal Cancer Screening
Colorectal cancer is the second leading cause of cancer related death. With over a 90% cure rate if caught early enough, early detection through screening is vitally important. The market for this type of test could reach about 250 million people worldwide. The gold standard screening test is colonoscopy, an invasive test, 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 currently not widely used for first line screening in short intervals. A non-invasive first-line screening test therefore should be used to screen larger numbers to identify individuals at risk of having the disease 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 nature of the test, the compliance rate is comparatively low (approximately 16% in the US). The introduction of a more convenient, patient-friendly, competitively performing screening test could potentially increase the number of individuals tested in shorter intervals. If positive, the patients would be followed up by colonoscopy. This could greatly increase the chances of disease being caught early with the goal of reducing mortality from colorectal cancer.
About Prostate Cancer
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 115,000 men will die from the disease every year. As with other cancers, the stage of disease at diagnosis affects overall survival rates and patients diagnosed with local or regional disease have a five-year survival rate of nearly 100%.
The current guidelines for prostate cancer screening, according to the American Cancer Society, advise testing for elevated prostate-specific antigen (PSA) and digital rectal examination (DRE) annually, beginning at the age of 50, in certain risk groups at 45. Positive findings in either of these exams is confirmed by prostate biopsy. PSA testing, although widely used, has some major drawbacks: PSA as a tumor biomarker has a moderate specificity, i.e. is also elevated in a number of benign prostate conditions leading to a large number of unnecessary prostate biopsies in men without prostate cancer. Furthermore, despite acceptable sensitivity of PSA, a subgroup of cancer patients does not show elevated PSA. Improved tests with increased specificity and sensitivity are clearly needed. The objective of Epigenomics’ prostate cancer screening test program is to develop a screening test for men over 50 years of age that is based on a panel of DNA methylation biomarkers and is more specific than PSA testing or can be used as a diagnostic follow-on for men with PSA elevated to 2.5 ng/ml or more.
About DNA Methylation
Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. Methylation is responsible for controlling the activity of genes by turning them off when not needed. Measuring the differences in the methylation patterns between healthy and diseased tissue can be used to detect a change in gene activity that could trigger diseases such as cancer. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns and uses them for developing molecular diagnostic tests.
About Epigenomics AG
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. Using DNA methylation markers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics’ defined business strategy covers two complementary core business areas. In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer. Based on easily obtainable body fluid samples, these tests are aimed at finding colorectal, prostate, breast, and lung cancer at an early stage before symptoms occur.
As a second core business area, Epigenomics develops tissue-based prognostic tests for prostate and breast cancer patients. With a strong focus on prostate cancer applications, these tests are developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). In this area Epigenomics retains the flexibility to decide on potential partnerships for marketing and sales 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.
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.
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