QIAGEN and EPIGENOMICS Enter into Strategic Collaboration in DNA Methylation
Leading Preanalytical Solutions for Methylation Analysis to Focus on In-Vitro Molecular Diagnostics and Pharmacogenomics Markets
Venlo , The Netherlands and Berlin , Germany - May 2, 2005 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) and Epigenomics AG ( Frankfurt , Prime Standard: ECX), announced today that they have entered into a strategic collaboration to jointly develop and introduce a gold-standard preanalytical solution portfolio for DNA methylation analysis. The jointly developed product portfolio is expected to provide complete and validated preanalytical solutions for use in pre-clinical research and to have full compatibility for use in in-vitro diagnostics (IVD).
The collaboration will combine Epigenomics' technology leadership in methylation analysis capabilities, including DNA bisulfite treatment, with QIAGEN's leadership in preanalytical sample preparation technologies in life sciences and molecular diagnostics. The primary goal of this collaboration is to translate these cutting-edge technologies into robust and reliable diagnostic kit components.
Bisulfite treatment of DNA, a technology in which Epigenomics is the world leader, is a critical and time consuming preanalytical step to enable analysis of DNA methylation on today's standard detection platforms. Bisulfite treatment is an integrated complex chemical modification of DNA following collection, stabilization and purification of the sample.
Under the terms of the collaboration agreement, QIAGEN obtained a world-wide exclusive license to develop, manufacture, market and sell preanalytical solutions containing bisulfite treatment technology for research purposes. In the diagnostics field, QIAGEN will market and sell stand-alone preanalytical solutions containing bisulfite treatment technology for use with Epigenomics' proprietary technologies and products.
In addition, QIAGEN received world-wide exclusive rights to Epigenomics' MethyLight assay technology for use in research applications and intends to develop first standardized reagent solutions for methylation pattern analysis.
Under an additional OEM (Original Equipment Manufacturer) agreement, QIAGEN will provide Epigenomics with kit components as the preanalytical basis for Epigenomics' growing product pipeline of leading molecular diagnostic products. All products developed under the agreement will be co-branded. First products are expected to be launched in 2006. Under the terms of the agreement, QIAGEN will pay up-front technology access and licensing fees, as well as royalties on all research products sales, to Epigenomics. Further financial details of the agreement were not disclosed.
"With over 200 publications on American Association for Cancer Research (AACR) alone, up from a single digit number just two years ago, the application of methylation research in clinical studies has demonstrated exciting momentum. Many of these methylation-related biomarkers are proving that they have very powerful and robust diagnostic value. We are expecting methylation research to have a strong role in clinical biomarker studies and molecular diagnostics," commented Peer Schatz, Chief Executive Officer of QIAGEN. "The complexity of the preanalytical steps in methylation analysis up until today has represented a significant challenge and impediment for faster growth of this sector. Through this partnership, we are acquiring access to Epigenomics' strong capabilities in methylation analysis. We intend to integrate these and certain QIAGEN technologies into complete preanalytical solutions that can dramatically simplify and streamline the process required for methylation analysis in research, clinical research and molecular diagnostics."
"We see this as the most powerful combination of brands and capabilities possible to make DNA methylation the leading molecular diagnostics technology," commented Alexander Olek, Chief Executive Officer of Epigenomics. "In the field of clinical methylation research and IVDs, we will be developing the must-have components. We hope to make possible horizontal integration of single nucleotide polymorphisms (SNPs) with methylation-based gene activity analysis, as well as eventually to provide vertical integration by offering preanalytical modules for all types of customers, from basic research through clinical studies and into regulated IVD settings," he continued. "We expect most users of methylation technologies to quickly converge on the methylation ‘operating system' that we plan to develop together with QIAGEN.
"This agreement is amazingly synergetic. We expect pervasive clinical research use of the products to be the most significant factor in the decision to include them into later IVDs; the standardization of IVDs on our platform may allow to initiate research in earlier phases based on products that will likely re-appear in quasi-identical form in regulated IVDs," added Kurt Berlin, Epigenomics' Chief Scientific Officer.
About DNA Methylation:
The ability to detect and quantify DNA methylation efficiently and accurately is an essential tool for scientists to study the role of epigenetic changes in cancer and other serious diseases, as well as many other clinical applications. Methylation is a natural process that occurs when a methyl group binds to one of DNA's four bases, cytosine. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases, such as cancer, is detected. Epigenomics has developed an industrial process that allows to read and interpret these methylation patterns.
QIAGEN N.V., a Netherlands holding company with subsidiaries in Germany, the United States, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria, Canada, and the Netherlands believes it is the world's leading provider of innovative enabling technologies and products for the separation, purification and handling of nucleic acids and proteins. QIAGEN has developed a comprehensive portfolio of more than 320 proprietary, consumable products for nucleic acid and protein separation, purification and handling, nucleic acid amplification, as well as automated instrumentation, synthetic nucleic acid products and related services. QIAGEN's products are sold in more than 42 countries throughout the world to academic research markets and to leading pharmaceutical and biotechnology companies. In addition, QIAGEN is positioning its products for sale into developing commercial markets, including DNA sequencing and genomics, nucleic acid-based molecular diagnostics, and genetic vaccination and gene therapy. QIAGEN employs approximately 1,400 people worldwide. Further information on QIAGEN can be found at http://www.qiagen.com/.
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic and pharmacodiagnostic products in cancer. The company has its headquarters in Berlin , Germany , and a wholly owned subsidiary in Seattle , USA . For more information, please visit our website at http://www.epigenomics.com/.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the DNA sequencing, genomics and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including seasonal fluctuations), difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussion in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
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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