QIAGEN announces broad agreement with Astellas Pharma to develop companion diagnostics
Oct 28 2014

QIAGEN announces broad agreement with Astellas Pharma to develop companion diagnostics

  • First two programs aim to create tests to aid in cancer treatment with Astellas compounds under development
  • QIAGEN Personalized Healthcare pipeline expands with novel assay targeting FGFR mutations
  • Partnership provides options for collaboration across therapeutic areas, sample types and testing technologies

Hilden, Germany, and Tokyo, Japan, October 28, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced a master collaboration agreement with Astellas Pharma Inc., an R&D-driven global pharmaceutical company headquartered in Japan, to develop and commercialize companion diagnostics paired with Astellas drugs for use in cancer and other diseases. The scope of the agreement is not restricted to certain sample types, platforms, indications or biomarkers, thereby giving Astellas access to QIAGEN’s development capabilities for assays based on PCR, NGS and multi-modal testing technologies using liquid and tissue biopsies. Two initial projects in the collaboration focus on oncology and aim to pair QIAGEN diagnostics with Astellas compounds in early-stage clinical trials: ASP5878, a fibroblast growth factor receptor (FGFR) inhibitor, and ASP8273, an EGFR inhibitor. Financial terms were not disclosed.

“We are very pleased to partner with Astellas to help maximize the benefits of their innovative new drugs with companion diagnostics from our development and commercialization engine. QIAGEN shares Astellas’ commitment to contribute actively toward improving the health of patients by realizing the benefits of personalized healthcare,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “With the master agreement and the first two projects to be disclosed, QIAGEN is further expanding its leadership in personalized medicine – including in Japan, one of the world's largest markets for companion diagnostics. The master agreement provides Astellas and QIAGEN flexibility and a strong foundation to add further development projects across other therapeutic areas, across analytical techniques, and across a broad array of sampling options.”

The Astellas collaboration is QIAGEN’s eighth framework agreement for developing companion diagnostics, underscoring the company's position as a preferred partner in personalized medicine. QIAGEN has more than 20 collaborative projects with pharma and biotech companies to develop, validate and market companion diagnostics to guide the treatment of cancers and a variety of other diseases. QIAGEN already markets tests for personalized healthcare applications based on more than 30 molecular biomarkers, and the company has a growing portfolio of novel biomarkers in development.

QIAGEN offers companion diagnostic programs spanning a range of automation platforms. A number of the tests are real-time PCR assays for analysis on the QIAsymphony family of instruments. In Japan, the world’s second-largest market for personalized healthcare, QIAGEN’s therascreen® EGFR RGQ PCR Kit in NSCLC and QIAGEN's therascreen® KRAS Mutation Detection Kit in colorectal cancer were launched in 2011. QIAGEN also is a global leader in developing companion diagnostics for next-generation sequencing (NGS) platforms. Earlier in 2014 QIAGEN added to its platforms for companion diagnostics the multi-modal, multi-analyte Modaplex, which enables laboratories to analyze multiple sample types simultaneously for dozens of DNA and RNA biomarkers. QIAGEN acquired this fast, cost-efficient workflow from PrimeraDx.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of June 30, 2014, QIAGEN employed approximately 4,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.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, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions 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, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; 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 and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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