Queue up with QIAGEN
October 2011
by Kelsey Kaustinen  |  Email the author


GERMANTOWN, Md.óQIAGEN recently announced a pair of collaborations, revealing that it has entered into separate partnerships with Eli Lilly & Co. and Pfizer Inc., both with a focus on companion diagnostics for cancer treatments. Financial details were not disclosed for either agreement.  
Lilly and QIAGEN will work together on the development, manufacturing and commercialization of a molecular companion diagnostic for Lilly's proprietary compound, called a JAK2 inhibitor. It targets the Janus kinase 2 (JAK2) gene, which plays a role in myeloproliferative neoplasms, an assortment of blood cancers that lead to abnormal growth of blood cells. Per the terms of the agreement, QIAGEN will develop a companion diagnostic test that will provide quantitative and qualitative results for the JAK2 V617F mutation to aid in the identification of patients who are more likely to respond to Lilly's JAK2 inhibitor.  
"The collaboration with Lilly is a strong testament to QIAGEN's capabilities in companion diagnostics, biomarkers and personalized healthcare," Dr. Stephen Little, vice president of personalized healthcare at QIAGEN, said in a press release. "We look forward to developing the potential for this innovative diagnostic-therapeutic combination to improve the standard of care for patients suffering from these blood cancers."  
Development and use of the QIAGEN JAK2 assay during clinical trials is also included in the partnership, as is manufacturing and joint commercialization of the diagnostic product in parallel with Lilly's compound. QIAGEN originally secured exclusive access to the JAK2 biomarker thanks to an agreement with Ipsogen, which it proposed to acquire in June.  
"QIAGEN's strategy is to establish a broad range of [companion diagnostic] partnerships which are not only commercially valuable in themselves, but also have the potential to improve patient outcomes and minimize drug wastage," says Little. "The Lilly partnership met all of these criteria."  
QIAGEN's partnership with Pfizer has a similar structure, except that the pair will be developing a companion diagnostic test for Pfizer's non-small cell lung cancer compound. The investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. Under the terms of the agreement, QIAGEN and Pfizer will collaborate on the development of a KRAS companion diagnostic to be used in conjunction with dacomitinib. The partnership includes clinical trials and submissions for a Premarket Approval application in the United States and the CE mark in Europe, in addition to applicable regulatory approvals in other regions.
"We are pleased to collaborate with Pfizer seeking to advance personalized healthcare with a new potential tool in the fight against non-small cell lung cancer, a major killer around the world," said Little in a press release. "This partnership unites QIAGEN's capabilities in companion diagnostics with Pfizer's scientific excellence and global presence to develop an innovative diagnostic-therapeutic combination with the potential to improve the standard of care for [non-small cell lung cancer] patients."
The companion diagnostic will be based on QIAGEN's proprietary KRAS assay technology, which identifies mutation in the KRAS gene. Since EGFR inhibitors are usually effective in patients without KRAS mutations, the new assay will aid in the identification of patients who will benefit the most from EGFR-inhibitor therapies. QIAGEN has already submitted an application for Premarket Approval for KRAS companion diagnostics to the U.S. Food and Drug Administration (FDA) for use with the other drugs that target metastatic colorectal cancers.  
Once clinical development is finished for the KRAS companion diagnostic for non-small cell lung cancer, QIAGEN intends to submit a premarket approval application supplement to the FDA for full automation of the workflow, which will grant pathologists access and easy processing of lung tissue samples.  
"We see business benefits for Pfizer and QIAGEN, improved healthcare for patients and reduced costs for healthcare providers," Little says of the partnership. "It really is a win-win-win situation."
Code: E101114

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