GERMANTOWN, Md.—QIAGEN recently announced a pair ofcollaborations, revealing that it has entered into separate partnerships withEli Lilly & Co. and Pfizer Inc., both with a focus on companion diagnosticsfor cancer treatments. Financial details were not disclosed for eitheragreement.
Lilly and QIAGEN will work together on the development,manufacturing and commercialization of a molecular companion diagnostic forLilly's proprietary compound, called a JAK2 inhibitor. It targets the Januskinase 2 (JAK2) gene, which plays a role in myeloproliferative neoplasms, anassortment of blood cancers that lead to abnormal growth of blood cells. Perthe terms of the agreement, QIAGEN will develop a companion diagnostic testthat will provide quantitative and qualitative results for the JAK2 V617Fmutation to aid in the identification of patients who are more likely torespond to Lilly's JAK2 inhibitor.
"The collaboration with Lilly is a strong testament toQIAGEN's capabilities in companion diagnostics, biomarkers and personalizedhealthcare," Dr. Stephen Little, vice president of personalized healthcare atQIAGEN, said in a press release. "We look forward to developing the potentialfor this innovative diagnostic-therapeutic combination to improve the standardof care for patients suffering from these blood cancers."
Development and use of the QIAGEN JAK2 assay during clinicaltrials is also included in the partnership, as is manufacturing and jointcommercialization of the diagnostic product in parallel with Lilly's compound.QIAGEN originally secured exclusive access to the JAK2 biomarker thanks to anagreement 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 inthemselves, but also have the potential to improve patient outcomes andminimize drug wastage," says Little. "The Lilly partnership met all of thesecriteria."
QIAGEN's partnership with Pfizer has a similar structure,except that the pair will be developing a companion diagnostic test forPfizer's non-small cell lung cancer compound. The investigational compound,dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 andHER-4 tyrosine kinases. Under the terms of the agreement, QIAGEN and Pfizerwill collaborate on the development of a KRAS companion diagnostic to be usedin conjunction with dacomitinib. The partnership includes clinical trials andsubmissions for a Premarket Approval application in the United States and theCE mark in Europe, in addition to applicable regulatory approvals in otherregions.
"We are pleased to collaborate with Pfizer seeking toadvance personalized healthcare with a new potential tool in the fight againstnon-small cell lung cancer, a major killer around the world," said Littlein a press release. "This partnership unites QIAGEN's capabilities incompanion diagnostics with Pfizer's scientific excellence and global presenceto develop an innovative diagnostic-therapeutic combination with the potentialto improve the standard of care for [non-small cell lung cancer]patients."
The companion diagnostic will be based on QIAGEN'sproprietary 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 themost from EGFR-inhibitor therapies. QIAGEN has already submitted an applicationfor Premarket Approval for KRAS companion diagnostics to the U.S. Food and DrugAdministration (FDA) for use with the other drugs that target metastaticcolorectal cancers.
Once clinical development is finished for the KRAS companiondiagnostic for non-small cell lung cancer, QIAGEN intends to submit a premarketapproval application supplement to the FDA for full automation of the workflow,which will grant pathologists access and easy processing of lung tissuesamples.
"We see business benefits for Pfizer and QIAGEN, improvedhealthcare for patients and reduced costs for healthcare providers," Littlesays of the partnership. "It really is a win-win-win situation."