Alkermes Buys Rodin Therapeutics to Bolster CNS Pipeline in $950 Million Deal
Rodin focuses on developing small molecule therapeutics for synaptopathies, which are diseases of the central nervous system related to a dysfunction of synapses. Rodin has been working to develop first-in-class, orally-available, brain-permeable drugs for this class of diseases by engineering molecules that target specific histone deacetylase (HDAC) complexes. Inhibition of the HDAC-co-repressor of repressor element-1 silencing transcription factor (CoREST) complex is thought to reactivate neuron gene expression, improve existing synapses and promote the growth and creation of new synapses.
“Synaptic loss and dysfunction are associated with certain clinical symptoms regardless of the underlying pathology,” said Craig Hopkinson, Alkermes’ chief medical officer and senior vice president of Medicines Development and Medical Affairs. “The platform that Rodin has developed may offer potential utility across a broad spectrum of neuropsychiatric, neurodegenerative and neurodevelopment disorders, such as Alzheimer’s disease, Huntington’s disease, frontotemporal dementia and depression. In addition, this novel science could have potential applicability in oncology and hematological disorders.”
Alkermes indicates it plans to advance Investigational New Drug (IND)-enabling activities for several of Rodin’s preclinical assets, potentially prioritizing them ahead of future clinical development of Rodin’s initial clinical candidate. Alkermes also says it will continue Rodin’s preclinical program on a subset of frontotemporal dementia patients that have an inherited mutation of the progranulin gene (FTD-GRN) and exploratory work in hematological disorders and oncology.
Under the terms of the deal, Alkermes is paying $100 million in cash upfront. Rodin will be eligible for future payments of up to $850 million based on clinical and regulatory milestones and sales thresholds.
Alkermes focuses on drugs for CNS diseases. Its commercial products include Aristada (aripiprazole lauroxil) for schizophrenia and Vivitrol (naltrexone) for alcohol dependence and opioid dependence. It also has licensed a number of products using its proprietary technologies to third parties in Europe.
Alkermes indicates it expects to incur about $20 million in incremental R&D expenses in 2020 related to Rodins’ development candidates.
On June 25, Rodin announced positive Phase I data for RDN-929, a selective HDAC-CoREST inhibitor. The drug was found to be safe and well-tolerated with favorable pharmacokinetic and pharmacodynamic properties. However, Alkermes’ statement suggest this drug may not be its top priority going forward.
“Rodin’s targeted approach to strengthening synaptic integrity is backed by a robust translational strategy and may have potential across multiple diseases which are characterized by impaired neuronal and synaptic function,” said Adam Rosenberg, Rodin’s chief executive officer. “With its proven ability to develop novel medicines for the treatment of CNS disorders, we believe Alkermes is ideally suited to advance this exciting new approach to neurologic diseases and bring potential new treatment options to patients that may benefit from Rodin’s synaptogenic platform.”
The deal comes less than a month after Alkermes slashed 160 jobs in order to “re-baseline” its expenses. At the time, Richard Pops, Alkermes’ chief executive officer, indicated the company was especially interested in licensing deals and mergers and acquisitions. In February, the U.S. Food and Drug Administration (FDA) rejected the company’s New Drug Application (NDA) for ALKS 541 for adjunctive treatment of major depressive disorder (MDD), requesting additional clinical data to prove effectiveness.