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Oncotest GmbH and Debiopharm Group™ Announce a Successful Partnership in the Identification of Biomarker Candidates

Oncotest GmbH and Debiopharm Group™ (Debiopharm) a Swiss-based global biopharmaceutical group, recently announced the successful completion of the first biomarker projects at Oncotest. In a recent study, pharmacological data was generated with Debiopharm’s investigational compound in Oncotest’s 3D assay system for patient-derived xenografts and correlated with the extensive Oncotest’s genomic and transcriptomic data. The collaboration resulted in the identification of several predictive biomarkers candidates including a gene signature.

“We are enthusiastic to work with Debiopharm on these projects and are looking forward to continue and expand our collaboration. I am convinced that the concept of deriving predictive biomarkers for new drugs already in a preclinical setting will make an impact. Ultimately, it has a significant potential to lower the attrition rates in clinical trials. Today, with our new biomarker department and the characterization data available for our tumor models, Oncotest is ideally positioned in this area.” said Prof. Heiner Fiebig, Founder and CEO of Oncotest.

Dr. Hiroaki Tanaka, Personalized Medicine Director at Debiopharm added: “Reliable preclinical models are key success factors in drug development. We believe that technologies based on the direct use of patient tumors have a game-changer potential in translational research in oncology. We are happy to collaborate with Oncotest, a pioneer and a leader in the area, and we are looking forward to extending our partnership even further towards the achievement of personalized medicine.”

Source: Debiopharm Group

Quintiles Selected as Preferred Central Laboratory Provider by Bristol-Myers Squibb

Quintiles today announced that it has been chosen as a preferred provider by Bristol-Myers Squibb Company (NYSE:BMY) to provide global support for Bristol-Myers Squibb’s central lab work, biomarker testing and assay development for the next five years.

Edison Pharmaceuticals, Inc. Signs Licensing Agreement with Dainippon Sumitomo Pharma Co., Ltd. for Development & Commercialization of Orphan Mitochondrial and Adult Central Nervous System Disease Drugs

Edison Pharmaceuticals recently announced that it has entered into a research/development and commercialization agreement with Dainippon Sumitomo Pharma Co., Ltd. (DSP) for the development of EPI-743 and EPI-589 in Japan. Under the terms of the agreement, DSP will gain development and commercialization rights in Japan in exchange for Edison receiving $35 million in upfront and $15 million in R&D support. In addition, Edison will be eligible to receive $10-35 million in development milestones per indication and up to $460M in commercial milestone payments as well as royalties on commercial sales.

The initial scope of the transaction includes both pediatric orphan inherited mitochondrial and adult central nervous system diseases. Under the terms of the agreement, DSP will undertake activities required for development, approval, and commercialization of EPI-743 in Japan. The work will initially focus on orphan pediatric mitochondrial disease. Edison will retain 100% ownership and direct all research, clinical, and commercial development of EPI-743 and EPI-589 outside of Japan.

In addition, the parties will collaborate on the research and development of EPI-589 with a focus on adult central nervous system disease. This collaboration is based upon the emerging body of data implicating redox and mitochondrial dysfunction as a root cause of neurologic disorders.
Edison’s translational platform is based on redox biochemistry. It bridges key learnings derived from genetically confirmed pediatric rare mitochondrial disease to adult central nervous system disorders where redox and mitochondrial dysfunction are likely to also play a critical role.

The Edison redox platform consists of proprietary laboratory and clinical tools that enable the discovery, optimization, and clinical validation of redox-directed drugs. Specifically, through employing both laboratory and clinically derived redox signatures of disease and drug action, Edison is able to develop drugs at a fraction of the time and cost of current drug development processes, thereby reducing risk and cost and increasing the likelihood of success.

Edison will use proceeds derived from the partnership to advance the late stage development and commercialization of EPI-743 for Leigh syndrome and Friedreich’s ataxia, as well as to advance EPI-743 in other exploratory phase 2 trials for rare pediatric diseases with shared mitochondrial mechanisms.

“Our partnership with Dainippon Sumitomo Pharma will allow Edison to accelerate the development and approval of the first drug for inherited respiratory chain diseases of the mitochondria,” stated Guy Miller , MD, PhD, Chairman and CEO of Edison. “Our shared vision of the role of redox control and the mitochondria in human disease will help us extend our learnings derived from rare pediatric diseases to poorly treated acute and chronic adult CNS diseases.”

Source: PR Newswire

Personal Genome Diagnostics Inc. Licenses Genome-Mapping Technology from Johns Hopkins University and Expands Its Cancer Genome Analysis Business

Personal Genome Diagnostics Inc. (PGDx), a pioneer in conducting patient-specific analyses aimed at identifying genomic alterations in tumors, today announced a number of developments that will support its expanding business. The company licensed exclusive rights to Digital Karyotyping (DK), an important genome-mapping technology developed by the company’s founders at Johns Hopkins University. PGDx also announced that it is expanding into new facilities and has made a number of key hires, including Genzyme Oncology executive Antony Newton as Chief Commercial Officer.

PrimeraDx to Co-Develop Companion Diagnostics with Quest Diagnostics

PrimeraDx, Inc., a molecular diagnostics company, recently announced it has formed a non-exclusive diagnostics co-development agreement with Quest Diagnostics (NYSE: DGX), the world’s leading diagnostics information services company. The intent of the collaboration is to co-develop and commercialize molecular diagnostic products and services with a focus on supporting clinical development of targeted therapeutics for drug developers.