Date: 2014-09-16
Type of information: Product acquisition
Compound: enzastaurin
Company: Denovo Biopharma (USA - CA) Eli Lilly (USA - IN)
Therapeutic area: Cancer - Oncology
Type agreement: product acquisition
Action mechanism: Enzastaurin (DB102, formerly LY317615 HCl) is an investigational oral small molecule, serine/threonine kinase inhibitor of the PKC beta and AKT pathways and has been studied in more than 3,000 patients across a range of solid and hematological tumor types. Enzastaurin has received orphan drug designation from the FDA and EMA.
Disease: diffuse large B-cell lymphoma
Details: * On September 16, 2014, Denovo Biopharma announced that it has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly and Company. Denovo gains all rights to develop, manufacture and commercialize enzastaurin globally, including transfer of all intellectual property and other rights, data, and information.
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.
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