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Dicerna Announces FDA Acceptance of Lilly's Investigational New Drug Application For First GalXC RNAi Candidate Under Companies' Global Research Collaboration And Licensing Agreement, Triggering $10M Payment To Dicerna

— Milestone Achievement Reflects First Investigational Candidate to Emerge Under Multi-Target Collaboration and Triggers $10 Million Payment to Dicerna — – Lilly Targeting Initiation of Phase 1

· 11/16/2020 07:31

— Milestone Achievement Reflects First Investigational Candidate to Emerge Under Multi-Target Collaboration and Triggers $10 Million Payment to Dicerna —

– Lilly Targeting Initiation of Phase 1 Clinical Trial of LY3561774 by Year-End 2020 –

LEXINGTON, Mass.--(BUSINESS WIRE)-- Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA), (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (“RNAi”) therapeutics, today announced U.S. Food and Drug Administration (“FDA”) acceptance of the Investigational New Drug Application (“IND”) filed by Eli Lilly and Company (“Lilly”) for LY3561774, the first clinical-stage candidate to emerge from Dicerna’s collaboration with Lilly. The IND milestone achievement triggers a $10 million payment to Dicerna and enables Lilly to initiate a Phase 1 clinical trial of LY3561774, which is expected before year-end 2020, for the treatment of an undisclosed cardiometabolic disease.

“The successful IND filing for LY3561774 marks an important milestone in what is expected to be the first of several resulting from our close, efficient collaboration with Lilly that could generate potentially life-saving RNAi-enabled therapies across a broad range of diseases,” said Bob D. Brown, Ph.D., Chief Scientific Officer and Executive Vice President of R&D at Dicerna. “We have already initiated more than 10 discovery programs under the collaboration since closing the agreement in late 2018, providing Lilly with the potential to advance a steady cadence of RNAi product candidates to the clinic in 2021 and beyond.”

The IND filing for LY3561774 is the first milestone achievement under a 2018 global licensing and research collaboration between Dicerna and Lilly focused on the discovery, development and commercialization of potential new therapies for cardiometabolic disease, neurodegeneration and pain. This investigational cardiometabolic therapy and future therapies to emerge from the two companies’ collaboration leverage Dicerna's proprietary RNAi technologies.

“We believe that RNAi-based medicines have the potential to be convenient and effective treatments for diseases with significant unmet need,” said Andrew C. Adams, Ph.D., Vice President of New Therapeutic Modalities at Lilly. “We are pleased to have achieved what we hope will be the first of several IND filings generated from our collaboration with Dicerna and look forward to initiating the Phase 1 clinical trial of LY3561774 in the coming weeks.”

This first IND filing under the collaboration agreement with Lilly triggers a $10 million milestone payment to Dicerna, which the Company received in November 2020. Under the agreement, Dicerna is eligible to receive up to $350 million in development and commercialization milestones for each GalXC™ hepatocyte target and $355 million for each non-hepatocyte target, as well as tiered royalties ranging from the mid-single-digits to low double-digits on potential product sales.