– Potentially first biomarker-guided schizophrenia therapeutic
– Novel mechanism of action with improved safety profile
– Denovo’s second late-stage asset acquired in the past 6 months
SAN DIEGO, March 3, 2015 /PRNewswire/ — Denovo Biopharma, LLC, today announced that it has exclusively licensed Pomaglumetad Methionil (mGlu2/3 receptor agonist), a late-stage neuroscience drug, from Eli Lilly and Company (NYSE: LLY). Denovo gains all rights to develop, manufacture and commercialize pomaglumetad globally, including transfer of all intellectual property and other rights, data, and information. Lilly has an option to re-acquire pomaglumetad upon a successful clinical trial, for predetermined undisclosed financial terms.
Pomaglumetad was primarily developed and tested in schizophrenia, including in Phase 2 and Phase 3 clinical trials. Predefined sub-population analysis and post-hoc analysis across multiple studies identified a meaningful subset of patients who showed significantly improved outcomes, although pomaglumetad did not meet the primary endpoint in the intent-to-treat population in Phase 3 studies. Denovo will use its proprietary platform to identify genetic biomarkers as a companion diagnostic to screen for appropriate patient subsets in future clinical trials and eventual commercialization.
"Denovo continues to acquire late-stage medicines to successfully develop with its integrated companion diagnostic and therapeutic development approach, including the acquisition of enzastaurin, a late-stage oncology therapeutic, in September 2014. Lilly is a world leader in the development of neuroscience drugs and will be a valuable collaborator in pomaglumetad’s continued development," said Michael F. Haller, Ph.D., Denovo Biopharma’s Chief Operating Officer.
About Pomaglumetad Methionil
Pomaglumetad Methionil (DB103, formerly LY2140023) is a novel glutamatergic-based investigational agent that does not interact with select central nervous system receptors that are thought to be responsible for many of the potential adverse events associated with some antipsychotic drugs which could compromise the treatment of patients with schizophrenia.
About Denovo Biopharma
Denovo Biopharma is a privately-held biotechnology company that provides novel and proprietary biomarker approaches to personalized drug development, including re-evaluating medicines that have failed in general patient populations and studying them in the original indication in biomarker-selected sub-populations. The company offers the first platform and algorithm for de novo genomic biomarker discovery using archived clinical samples. This technology may be especially useful for compounds with suboptimal late-stage trial results. By identifying biomarkers correlated with patients’ responses to drug candidates retrospectively, Denovo enables the design and execution of follow-on clinical trials in targeted patient populations with increased likelihood of success. For additional information please visit www.denovobiopharma.com.
Michael Haller, Chief Operating Officer
Denovo Biopharma, LLC