QIAGEN and Epigenomics Expand Successul Partnership
QIAGEN acquires exclusive world wide license to Epigenomics' preanalytical DNA-Methylation Technology for use in Molecuar Diagnostics
Venlo, The Netherlands and Berlin, Germany, May 29, 2007 - QIAGEN N.V. (Nasdaq: QGEN, Frankfurt, Prime Standard: QIA) and Epigenomics AG (Frankfurt Prime Standard: ECX) today announced that the companies further expanded their existing strategic partnership by a new license agreement.
This new collaboration expands already existing licensing agreements announced in 2005 and now provides QIAGEN with the exclusive world-wide rights to Epigenomics' sample technologies for use in applied testing and in in vitro molecular diagnostics. Epigenomics retains rights to these technologies for use in its own or partnered development projects and for the commercialization of in vitro molecular diagnostic products via a non-exclusive back-license from QIAGEN.
As part of the agreement, Epigenomics will receive an up-front fee and further milestone payments and royalties. Further financial terms were not disclosed.
The expansion of the partnership follows the very successful launch of a first research-use only product, the EpiTectTM Bisulfite Kit, by QIAGEN in spring 2006. QIAGEN's EpiTectTM Bisulfite Kit was developed in collaboration with Epigenomics and combines technologies from QIAGEN with technologies from Epigenomics for DNA methylation analysis. The product facilitates the complex and time consuming step of bisulfite treatment of DNA in DNA methylation analysis. On the basis of this first product the companies intend to develop and market a complete and validated IVD (in vitro diagnostic) preanalytical sample technology portfolio for molecular diagnostic tests based on DNA methylation.
"We expect DNA methylation technology to play an important role in key segments of the fast growing molecular diagnostics market such as in cancer screening. QIAGEN provides a complete portfolio of standardized technologies and solutions for epigenetic testing, from sample technologies such as DNA sample collection, stabilization, purification and bisulfite conversion to assay technologies such as PCR- and sequencing- based methods for DNA methylation analysis," said Peer Schatz, Chief Executive Officer of QIAGEN. "We are pleased with our partnership with Epigenomics, a leader in DNA methylation technology. The combination of the capabilities of both companies is setting strong standards for the use of the exciting epigenetic technologies in research, applied testing and molecular diagnostics."
"The new agreement aims at further leveraging our DNA methylation technology for the global diagnostics market," commented Geert Nygaard, Chief Executive Officer of Epigenomics. "The pretreatment of DNA samples with bisulfite is a critical step in DNA methylation analysis and key to the performance and quality of a diagnostic test. QIAGEN as the market and technology leader in sample technologies is the partner of choice to develop IVD preanalytics solutions for DNA methylation analysis. These can be used with our cancer screening tests addressing markets with a target group of over 300 million individuals worldwide. Such IVD preanalytical product portfolio provided by QIAGEN will be of highest value for our customers and partners in clinical research and molecular diagnostics. In addition, we will profit from the expected future growth of these product based on the success of DNA methylation tests developed by other companies."
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) in most cases causes the shut-down of gene activity. As different cells shut off different genes, every cell type has its unique DNA methylation "fingerprint" that changes in various normal biological processes and many common diseases, in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and also the prediction to therapeutic intervention.
DNA methylation biomarkers have multiple advantages. Highly sensitive detection methods allow the detection of tumor derived DNA based cancer-specific DNA methylation patterns in body fluids such as blood or urine. Further, DNA methylation can easily be quantified as the unmethylated DNA of the same gene in the sample can serve as an internal reference. As DNA methylation is stable in routine clinical sample processing, it can be analyzed in tissue samples fixed and paraffin embedded for histological analysis by the pathologists. Epigenomics has developed a broad technology portfolio and the know-how to identify and validate DNA methylation biomarkers and use them for the development of molecular diagnostic tests. Several early detection tests for cancer, based on DNA methylation, that address the mass markets for cancer screening with up to 300 million individuals aged 50 and older are currently under development by Epigenomics and others.
About QIAGEN N.V.:
QIAGEN N.V., a Netherlands holding company is the leading provider of innovative sample and assay technologies and products. QIAGEN's products are considered standards in areas such pre-analytical sample preparation and assay solutions in research for life sciences, applied testing and molecular diagnostics. QIAGEN has developed a comprehensive portfolio of more than 500 proprietary, consumable products and automated solutions for sample collection, nucleic acid and protein handling, separation, and purification and open and target specific assays. The company's products are sold to academic research markets, to leading pharmaceutical and biotechnology companies, to applied testing customers (such as in forensics, veterinary, biodefense and industrial applications) as well as to molecular diagnostics laboratories. QIAGEN employs more than 1,900 people worldwide. QIAGEN products are sold through a dedicated sales force and a global network of distributors in more than 40 countries. In this press release QIAGEN is using the term molecular diagnostics. The use of this term in reference to certain countries, such as the United States, is limited to products subject to regulatory requirements. Current QIAGEN molecular diagnostics products are 34 EU CE IVD assays, six EU CE IVD sample preparation products, one 510k PAX RNA product, nine China SFDA IVD assays and 98 general purpose reagents. Further information about QIAGEN can be found at http://www.qiagen.com/.
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 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, mass-market products with huge potentials. Based on easily obtainable 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 an extensively 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 and eventually the US..
Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 200 patent families 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 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 applied testing markets, clinical research markets 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 fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, 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' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions 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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