12.18.06
Epigenomics Reviewing Options for Commercialization of Cancer Screening Tests
Following the recent announcement of the end of the the Roche collaboration, Epigenomics has issued a press release indicating its intent to “review all options for a fast commercialization of the cancer screening tests.”
- 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. Link
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