On September 16, 2014 Denovo Biopharma reported that it has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly and Company (Press release Denovo Biopharma, SEP 16, 2014, View Source [SID:1234501031]). Denovo gains all rights to develop, manufacture and commercialize enzastaurin globally, including transfer of all intellectual property and other rights, data, and information.
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Lilly developed enzastaurin in a variety of indications, including in Phase 2 and Phase 3 clinical trials for diffuse large B-cell lymphoma (DLBCL). In studies conducted by Lilly, enzastaurin achieved promising clinical results in the DLBCL induction setting in Phase 2 trials, but did not meet the primary endpoint in the DLBCL maintenance setting in the Phase 3 study. A meaningful subset of patients showed significantly improved progression-free survival and Denovo Biopharma intends to conduct genetic analysis to identify biomarkers that are related to this outcome. By identifying genomic biomarkers that correlate with patients’ responsiveness to treatment, Denovo plans to screen for appropriate patient subsets for enrollment in future clinical trials that the company plans to conduct.
"We appreciate Lilly’s extensive efforts in the development of enzastaurin to date. As our first late-stage asset acquired from a premier pharmaceutical company, this high quality data package will enable Denovo to conduct our retrospective biomarker discovery," saidMichael F. Haller, Ph.D., Denovo Biopharma’s Chief Operating Officer. "Our biomarker discovery efforts take only a few months, so when combined with Lilly’s existing data package, we should be able to rapidly initiate a biomarker validation clinical trial for the original indication (DLBCL). We are actively seeking to acquire additional drugs in late-stage development where we can utilize our biomarker discovery platform to personalize and advance other potential treatments in similar fashion."