epigenomics
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Network & Partners

 
Strategic Partners
 

09/2007, 10/2008: Abbott Molecular. In September 2007 we signed a non-exclusive strategic collaboration and license agreement in molecular diagnostics with Abbott, a global healthcare company. Under the agreement, Abbott intends to develop an in vitro diagnostic blood test for the early detection of colorectal cancer based on our proprietary DNA methylation biomarker mSEPT9. Abbott anticipates launching a CE-marked test in Europe in 2009 followed by regulatory filing for U.S. approval in 2010. 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. To facilitate this, Abbott in November 2008 in an expansion of the original agreement aquired access to patient specimen collected by Epigenomics within the PRESEPT Study. Under the partnership, Abbott may also evaluate some of our other proprietary biomarkers for additional cancer indications.

02/2008, 02/2009: Quest Diagnostics Inc. In February 2008 we signed a non-exclusive licensing agreement for its proprietary DNA methylation biomarker mSEPT9 with Quest Diagnostics Incorporated, the leading provider of diagnostic testing, information and services in the U.S. Under the agreement, Quest Diagnostics has obtained rights to uses of the SEPT9 DNA methylation biomarker to develop a molecular-based laboratory test that can help physicians detect colorectal cancer based on a patient’s blood specimen. Quest Diagnostics plans to develop the SEPT9 DNA methylation test to act as a supplement to conventional methods of colorectal cancer screening, including colonoscopy and fecal occult blood tests (FOBTs). Quest Diagnostics is the first commercial laboratory in the U.S. to non-exclusively license the Septin 9 biomarker from us with the goal of commercializing a laboratory-developed blood test. In February 2009, Quest Diagnostics also obtained rights to uses of the GSTP1 DNA methylation biomarker (mGSTP1) to establish and commercialize a molecular-based laboratory-developed test that can help pathologists better diagnose prostate cancer based on testing of a patient’s tissue specimen. 

08/2009: ARUP Laboratories, Inc. In August 2009, Salt Lake City, Utah, U.S. based ARUP Laboratories, Inc. (ARUP), a leading provider of diagnostic testing services obtained rights to use the mSEPT9 biomarker to develop a molecular-based laboratory test that can help physicians detect colorectal cancer based on a patient’s blood sample. ARUP is the second commercial laboratory in the U.S.A. to non-exclusively license the mSEPT9 biomarker from Epigenomics with the goal of commercializing a laboratory-developed blood test. 

01/2009: Sysmex Corporation. In January 2009 we signed a strategic research and development collaboration agreement with the Japanese Sysmex Corporation. Under the terms of the agreement, Sysmex and Epigenomics will assess the suitability of Sysmex’s molecular diagnostics instrumentation for the detection of DNA methylation cancer biomarkers in blood. As a benchmark for the development of its assay system, Sysmex will use Epigenomics’ mSEPT9 Methylation Detection Assay commercially available as a research use only product. If successful, Sysmex intends to develop and commercialize initially in Japan a blood test for the early detection of colorectal cancer based on Epigenomics’ proprietary SEPT9 DNA Methylation Biomarker (mSEPT9). 

12/2008: Philips. In December 2008 we entered into a collaboration and licensing agreement with Philips focusing on novel technologies and methods targeted at the diagnosis of various cancers. Under the agreement we will jointly with Philips perform feasibility studies aimed at developing an integrated and fully automated instrument platform for the diagnosis of certain cancers based on DNA methylation biomarkers. In addition, Philips obtained the option to license the required technologies and biomarkers separately or in combination for diagnostic applications. The option may be exercised upon the successful completion of the feasibility studies.

 

04/2009: Predictive Biosciences Incorporated: In April 2009 we entered into a non-exclusive licensing agreement for our proprietary biomarker mGSTP1 with U.S.-based Predictive Biosciences Incorporated, an innovative and privately held cancer molecular diagnostics company. Under the agreement, Predictive Biosciences has obtained rights to uses of the GSTP1 DNA methylation biomarker (mGSTP1) to establish and commercialize a molecular-based laboratory-developed test that can help urologists and pathologists better diagnose and manage prostate cancer. Epigenomics and others have demonstrated that methylated DNA of the GSTP1 gene in tissue may indicate the presence of prostate cancer. 

 

05/2007, 04/2005: Qiagen GmbH. In April 2005, we established a strategic collaboration with Qiagen, a leading provider of innovative technologies and products for pre- analytical sample preparation and molecular diagnostics solutions. The partnership aims at jointly developing and introducing a "gold-standard" pre-analytical solution portfolio for DNA methylation analysis. As first product based on our technology, Qiagen launched in spring 2006 the EpiTect® Bisulfite Kit for standardized conversion and cleanup of DNA for methylation analysis. Initially limited to the world wide rights for the development, manufacturing, commercialization of pre-analytical solutions containing bisulfite treatment technology and the MethylLight assay technology for research purposes, the collaboration was broadened in May 2007 by a further licensing agreement granting the exclusive worldwide rights to our sample technologies for use in applied testing and in in-vitro molecular diagnostics. We retain the rights to these technologies for use in our own or partnered development projects and for the commercialization of molecular diagnostics. As we will develop our cancer screening and specialty diagnostics tests alone or in collaboration with IVD partners, we can make use of the pre-analytical IVD solutions developed by Qiagen but can also develop pre-analytical solutions on our own or together with our IVD partners.

01/2008, 07/2009: DxS Ltd. (now Qiagen) In January 2008 we have entered into a strategic cross-licensing agreement with DXS Ltd.. Under the terms of the agreement, we obtain worldwide non-exclusive rights to DxS’ proprietary Scorpions® technology for R&D use and research kits, as well as an option to expand the license to the in vitro diagnostics (IVD) field. We intend to use this technology both in certain research kits as well as potentially in our cancer specialty diagnostics products. DxS in return receives an option for a worldwide non-exclusive license and further options to certain our IP covering the use of Scorpions® technology for DNA methylation applications. Both we and DxS have acquired options to sub-licensing rights for the respective technologies. In July 2009 DxS and Epigenomics executed their respective IVD options under the original agreement. Both companies now have the non-exclusive rights use the Scorpions® technology in DNA methylation IVD products. In September 2009 DxS was acquired by Qiagen.

 

06/2006: Affymetrix Inc and Epigenomics enter into a strategic partnership. Under the „Powered by Affymetrix®“ program Affymetrix has granted us non-exclusive access to Affymetrix microarray technology to develop and market microarray-based IVD tests for certain indications in oncology and further optional fields. This includes the GeneChip® System 3000Dx (GCS3000Dx), the first microarray instrumentation system for molecular diagnostic laboratories. The GCS3000Dx has already been granted regulatory clearance by the FDA and is CE marked in the European Union for IVD use in genetic testing. The first product we developed for this platfom is our prognostic mPITX2 test for prostate cancer.
 
01/2008: OncoMethylome Sciences S.A. In January 2008 we have entered into a broad technology licensing agreement with OMS. Under the terms of the agreement, OMS obtained worldwide non-exclusive rights to several of our proprietary core technologies such as its MethyLight portfolio for the sensitive and quantitative detection of DNA methylation for in vitro diagnostic product development and commercialization. Further, OMS obtained rights to HeavyMethyl® technology, plus certain microarray-based technologies for DNA methylation analysis. In return for the licenses, we will receive an up-front payment and are eligible for royalties to be paid on any eventual commercial exploitation of the technologies by OMS and any of its partners who choose to sublicense such technology.  
 

Biomarker R&D Partnerships
 
 
08 / 2006 - 2009: Janssen Pharmaceutica N.V. (a Johnson & Johnson Company) in 2006 frist entered into a research and development collaboration with us. In this collabroation we use our proprietary differential methylation hybridization (DMH) chip technology and other technolgoeis and strategies to discover biomarkers that may support the development of oncology compounds. The collaboration is ongoing and several projects were successfully completed since 2006. 
   
10/2007: Pharmion Corporation (Boulder, Co) and Epigenomics entered into a Master Services Agreement under which Epigenomics will provide DNA methylation services in connection with certain development programs that Pharmion is conducting. 
 

05/2007: Myriad Genetics Inc. entered into an R&D-partnership with Epigenomics to identify DNA methylation biomarkers perdicting patients' reponse to a marketed oncology drug. Within the project, Epigenomics will use its proprietary DMH technology, and OncoSignTM, a method for the rapid identification of biomarkers.

 

12/2006: Centocor Inc., a US based biomedicines company and Epigenomics entered into an R&D collaboration to identify and analyze potential biomarkers for use in Centocor’s oncology program.
 
08/2006: Schering AG (now Bayer-Schering-Pharma AG) and Epigenomics entered into an R&D collaboration on a biomarker study in a preclinical cancer model.
 
    10/2004: Biogen Idec and Epigenomics entered three different pharmacodiagnostic research collaborations over the last couple of months.
 Pfizer     09/2004: Pfizer became a customer of Epigenomics
   11/2003: AstraZeneca and Epigenomics started an initial collaboration to develop DNA-methylation biomarkers for their oncology drugs, initially focussing on IRESSA.
   12/2003: Wyeth and Epigenomics initially collaborate on the development of drug response biomarkers for an anti-cancer drug developed by Wyeth in xenograft mice.
   10/2001: MethylGene and Epigenomics started a first partnership in which Epigenomics investigated gene methylation changes of patients enrolled in Phase II trials. The project was successfully completed in 2003.

Academic partners

Over the past 10 years we have built a network of academic and clinical partnerships to draw on the specific expertise and resources of leading clinical centers and research institutions for the development of DNA methylation-based products. Collaborative research programs include disease specific collaborations with clinical and pathological laboratories and key opinion leaders in the respective disease area as well as programs for the development of new technologies for DNA methylation detection, the latter typically supported by public funding.

Our collaborations include more than 50 university departments or academic groups, inter alia Partners at the Charité – Universitätsmedizin Berlin (Berlin, Germany), University Medical Center Hamburg-Eppendorf (Hamburg, Germany), Roy Castle Lung Cancer Foundation (Liverpool, UK), University Hospital of the ETH Zurich (Zurich, Switzerland), University of North Carolina, School of Medicine (Chapel Hill, NC, U.S.), and Duke University (Durham, NC, U.S.). As part of our PRESEPT Study, we are working with 32 clinical sites in the U.S. and Germany.


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