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Press release from Business Wire

Illumina Announces Strategic Partnerships with AstraZeneca, Janssen and Sanofi to Redefine Companion Diagnostics for Oncology

Thursday, August 21, 2014

Illumina Announces Strategic Partnerships with AstraZeneca, Janssen and Sanofi to Redefine Companion Diagnostics for Oncology

02:00 EDT Thursday, August 21, 2014

SAN DIEGO (Business Wire) -- Illumina, Inc. (NASDAQ:ILMN) today announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing (NGS)-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca, Janssen Biotech, Inc., and Sanofi (EURONEXT: SAN and NYSE: SNY).

Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners' clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”

“The transition to patient-centered companion therapeutics marks a new era for oncology, and we are pleased to see pharmaceutical companies working with Illumina on a universal platform to bring life-saving treatments through their development pipelines,” said Ellen V. Sigal, Ph.D., Chair and Founder of Friends of Cancer Research. “This is the type of collaboration that will make real progress for patients.”

Ruth March, Vice President, Personalised Healthcare & Biomarkers at AstraZeneca, said, “This partnership has the potential to deliver an unprecedented amount of clinical information from a single test. Illumina's technology will inform doctors about the molecular make-up of their patients' tumors, enabling them to match medicines to the drivers of disease. Our aim is that doctors can use these tests to prescribe the right drugs to the right patients – bringing benefits to healthcare professionals, payers and patients alike.”

To date 125 known cancer driver genes have been discovered – 71 tumor suppressors and 54 oncogenes – that drive tumor growth through 12 cellular signaling pathways.1 While today the number of available targeted therapies is limited, an estimated 800 oncology drugs are in development, many of which are designed to target specific mutations. With the emergence of new targeted therapies, there is growing need for new companion diagnostic tests.

“Building on our experience with the MiSeqDx, the only FDA-cleared NGS platform, as well as the additional regulatory expertise we gained with the acquisition of Myraqa, Illumina is developing the universal test system to support our partners' oncology drug pipelines,” said Rick Klausner, M.D., Illumina's Chief Medical Officer. “These agreements represent the deep engagement between Illumina and the pharma community to create the technical, clinical, regulatory and ultimately commercial solutions for the next generation of molecular oncology. We're excited to be working together to maximize benefits to patients with cancer.”

For more information, visit www.illumina.com/precisionmedicine.

About Illumina

Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paving the way for molecular medicine and ultimately transforming healthcare.

Forward-Looking Statements

This release may contain forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.

1 Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA, et al. (2013) Cancer Genome Landscapes. Science 339: 1546–1548.

Illumina, Inc.
Investors:
Rebecca Chambers
858-255-5243
rchambers@illumina.com
or
Media:
Jennifer Temple
858-882-6822
pr@illumina.com

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