CDx deal is thrice as nice
February 2013
by Amy Swinderman  |  Email the author


CAMBRIDGE, Mass.—Seeking to bring a third party into their agreement to develop and commercialize a companion diagnostic (CDx) test for patients with genetically defined cancers, Eisai Co. Ltd. and Epizyme Inc. have selected Roche's Molecular Diagnostics unit to supply the requisite technology and platform.
On Jan. 7, the companies announced a collaboration to develop an in-vitro polymerase chain reaction (PCR)-based CDx test, with the goal of enabling the identification of lymphoma patients with non-wild type EZH2, including the Y641 mutation. The CDx will be used to detect the EZH2 mutation in subjects to determine enrollment eligibility for dosing with a compound that Epizyme and Eisai are developing.  
"Roche is a company that possessed world-class cutting-edge technology and know-how, and has a proven history of companion diagnostic approvals," says Lynn W. Kenney, senior director of corporate communications for Eisai, of the company's decision to bring Roche into the fold.  
Epizyme and Eisai announced their collaboration in March 2011. That agreement gave Epizyme $6 million up front, with the potential to earn more than $200 million in additional research, development and sales milestones, and up to double-digit royalties. Eisai agreed to fund 100 percent of the R&D costs through human proof-of-concept, at which point Epizyme has the right to opt into a profit-sharing and co-commercialization arrangement for the United States.  
In a September 2012 Nature Chemical Biology paper, "A selective inhibitor of EZH2 blocks H3K27 methylation and kills mutant lymphoma cells," Epizyme reported that lymphomas with genetic alterations of EZH2 require EZH2 enzymatic activity for proliferation, and suggested that EZH2 is a driving oncogene in these cancers and therefore an important therapeutic target.  
Ultimately, if the compound is successful in clinical studies and receives regulatory approval, the parties hope to make a companion diagnostic available to help physicians identify patient candidates with the EZH2-related mutation who may be likely to benefit from the approved drug.   
"Our collaboration with Epizyme and Eisai highlights Roche's position as the partner of choice for the development and commercialization of companion diagnostics for personalized healthcare," said Paul Brown, head of Roche Molecular Diagnostics, in a statement. "We are excited to be developing a diagnostic test that will support Epizyme and Eisai in the development of an EZH2 inhibitor as a new therapeutic for patients with genetically defined lymphomas."  
The companies declined to comment on the commercial potential of the test.  
Code: E021313

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