Therapy Areas: Diabetes
Novaremed Inks License Agreement with NeuroFront for the Non-opioid Neuropathic Pain Treatment, NRD.E1, for Greater China and Singapore
21 July 2022 - - Switzerland-based biopharmaceutical company Novaremed AG and China-based NeuroFront Therapeutics (Hong Kong) Ltd. have signed an exclusive collaboration and commercialization agreement for Novaremed's innovative non-opioid investigational drug, NRD.E1, being developed for the treatment of diabetes-related neuropathic pain and other neuropathic pain indications, the companies said.

Under the terms of the agreement, Novaremed is eligible to receive from NeuroFront over USD 130m in option and exercise fees as well as development, regulatory and sales milestone payments plus royalties on net sales.

Under the terms of the agreement, Novaremed will grant NeuroFront an exclusive option to obtain exclusive development, commercialization and manufacturing rights to NRD.E1, Novaremed's first-in-class, innovative non-opioid investigational drug candidate for the treatment of neuropathic pain.

The agreement allows NeuroFront to develop and commercialize NRD.E1 as treatment of painful diabetic peripheral neuropathy 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 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.

This partnership and the transaction were facilitated with the assistance of Cukierman and company Investment House.

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 Novaremed's lead drug candidate currently being developed to treat painful diabetic peripheral neuropathy.

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.

On the basis of these results, NRD.E1 has been granted Fast Track Designation by the US FDA and was selected by the National Institutes of Health 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.

NeuroFront is a China-based clinical stage neuroscience biotech company with a focus on developing and commercializing innovative neuroscience therapies to address unmet needs and improve patients' lives in China and Asia.

The company was established by life sciences investors, including Nan Fung Life Sciences and Pivotal bioVenture Partners China, and is led by an elite team of neuroscience industry veterans with substantial and compelling expertise in China and globally in both R and D and the commercialization of CNS products.

NeuroFront is building a portfolio of innovative, transformative CNS therapies that treat migraine, painful diabetic peripheral neuropathy, depression, ADHD, and other CNS diseases with high unmet medical needs.

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 product is NRD.E1, an orally active non-opioid small molecule with a novel mechanism of action, has FDA Fast Track Designation and IND-approval to proceed with a Phase 2b clinical trial for the treatment of painful diabetic peripheral neuropathy.
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