QIAGEN announces third co-development program for companion diagnostics paired with Lilly’s investigational cancer compounds

  •  Collaboration aims to use QIAGEN’s companion diagnostic development capabilities to create a companion diagnostic paired with a novel oncology compound from Lilly
  • New partnership builds on Lilly-QIAGEN framework agreement for development of advanced diagnostic tests to guide treatment with innovative therapies
  • Third project follows success of FDA-approved therascreen KRAS test in metastatic colorectal cancer and clinical development of JAK2 genetic test in blood cancers

Hilden, Germany, and Germantown, Maryland, November 18, 2013 – QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced an agreement with Eli Lilly and Company (NYSE: LLY) to develop and commercialize a molecular companion diagnostic paired with a novel Lilly oncology compound. This is the third co-development project by QIAGEN and Lilly to create companion diagnostics, which are tests that analyze genomic information in patient samples to enable personalized decisions on treatments. The latest collaboration, involving an undisclosed Lilly compound and an undisclosed molecular diagnostic target, builds on a master collaboration agreement for development of tailored therapies in cancer and other therapeutic areas signed earlier this year.

QIAGEN and Lilly are long-standing partners in personalized healthcare. QIAGEN’s therascreen® KRAS RGQ PCR Kit has been widely adopted by laboratories since its July 2012 approval by the Food and Drug Administration (FDA) as a companion diagnostic. The therascreen KRAS Test detects gene mutations in metastatic colorectal cancer patients, indicating which ones will benefit from Erbitux. In September 2011, QIAGEN and Lilly partnered to develop a companion diagnostic that evaluates the Janus kinase 2 (JAK2) gene, which plays a role in some blood cancers. The test is paired with a Lilly compound to guide use of the proposed drug, currently in clinical trials.

"We are pleased to partner with Lilly on a third development program to improve life for cancer patients through companion diagnostics that guide the use of novel targeted medications. QIAGEN is a preferred partner for leading pharmaceutical companies like Lilly because our validated development processes and regulatory track record provide an accelerated path to commercialization,” said Peer Schatz, QIAGEN’s Chief Executive Officer. “Using standardized, well-validated processes to develop and commercialize companion diagnostics reduces the risks in drug development for Pharma companies. Once approved, our therascreen tests have a ready path to commercial adoption since laboratories around the world have embraced QIAGEN’s efficient QIAsymphony automation platform."

"Partnering with QIAGEN on this program enables Lilly to continue to advance our goal of providing tailored therapies to patients in need," said Daniel Skovronsky, M.D., Ph.D., vice president, tailored therapeutics, Lilly and CEO, Avid Radiopharmaceuticals, Lilly’s wholly owned molecular imaging subsidiary. “The QIAGEN and Lilly teams have formed strong working relationships and we look forward to working with QIAGEN to advance this latest innovation together.”

The Lilly co-development program and others are designing companion diagnostics that offer laboratories an efficient workflow on QIAGEN’s Rotor-Gene Q MDx instrument using real-time PCR technology. The Rotor-Gene Q MDx is part of the QIAsymphony family of automated platforms.
In addition to the Lilly collaboration, QIAGEN is a leading partner globally in developing and validating companion diagnostics to transform patient care and extend lives by providing personalized genomic information to guide treatment decisions in cancer and other diseases. More than 15 projects with pharmaceutical and biotech companies are underway to create new companion diagnostics. In addition to the FDA-approved therascreen KRAS test, QIAGEN received FDA approval in July 2013 for the therascreen® EGFR RGQ PCR Kit as a companion diagnostic for a new targeted therapy in metastatic NSCLC patients whose tumors have certain gene mutations. Globally, QIAGEN offers the broadest portfolio of companion diagnostics, including the therascreen EGFR and KRAS kits in Japan, and more than 15 CE-marked assays for personalized healthcare applications in Europe.

About QIAGEN

QIAGEN N.V. is a Netherlands holding company publically traded on NASDAQ and Frankfurt Prime Standard. The Company is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular insights. 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 September 30, 2013, QIAGEN employed more than 4,100 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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