Basel-based Novaremed AG and NeuroFront Therapeutics from Hong Kong, have signed an exclusive collaboration and commercialization agreement for Novaremed’s innovative non-opioid investigational drug, NRD.E1. Novaremed is entitled to receive over USD 130 million in option and exercise fees as well as development, regulatory and sales milestone payments plus royalties on net sales.
Novaremed AG, a privately held clinical-stage biopharmaceutical company, is developing a pipeline of innovative medications for chronic pain management to address the high unmet medical need for better pain relief and as an alternative to opioids. Its lead candidate NRD.E1 is an orally active small molecule with a novel mechanism of action by modulating Lyn kinase and has patent protection until 2040. NRD.E1 is currently being developed to treat painful diabetic peripheral neuropathy (PDPN).
Novaremed successfully completed three Phase 1 studies and one double-blind, placebo-controlled Phase 2a dose-finding proof-of-concept study in which NRD.E1 showed a clinically relevant reduction in patient-reported pain (measured as an improvement in mean neuropathic pain score) and was very well tolerated at all doses tested.
Under the terms of the agreement, Novaremed will grant NeuroFront an exclusive option to obtain exclusive development, commercialization and manufacturing rights to NRD.E1. The agreement allows NeuroFront to develop and commercialize NRD.E1 as treatment of painful diabetic peripheral neuropathy (PDPN) and any other neuropathic pain indications in the Greater China territory (including Mainland China, Hong Kong, Macau, and Taiwan) and Singapore. NeuroFront has the right to exercise its license option at its discretion, but no later than upon completion of the Phase 2b trial of NRD.E1 in PDPN, which will start patient enrollment in the coming weeks.
In case NeuroFront successfully develops and registers NRD.E1 in additional neuropathic pain indications in the licensed territory, Novaremed is also eligible to receive additional development and regulatory milestone payments for each additional indication. In total, the startup will receive USD 130 million.
“There are up to 19 million patients suffering from PDPN in China, but no new innovative drug has been introduced in the market for more than 15 years. There exists a significant unmet medical need and hence a great opportunity for NRD.E1, a first-in-class, novel treatment that has already demonstrated clinical effectiveness in a Phase 2a clinical trial and subsequently received US FDA Fast Track Designation and NIH sponsorship for its Phase 2b trial,” said June Yan, CEO of NeuroFront. “NeuroFront is very excited to partner with Novaremed to change the lives of many PDPN patients in Greater China and Singapore.”
NRD.E1 has been granted Fast Track Designation by the US FDA and was selected by the National Institutes of Health (NIH) in the US as the only oral agent to be included in the NIH-HEAL (Help End Long-term Addiction) program. The NIH will sponsor and execute a 12-week, double-blind, placebo-controlled Phase 2b study in patients with moderate to severe PDPN in the US. Recruitment into this clinical trial will start in coming weeks.
(Press release)
Please login or sign up to comment.
Commenting guidelines