VISCHER berät Novaremed bei Options- und Lizenzvertrag für NRD.E1 mit NeuroFront

Novaremed AG, ein privat gehaltenes, im klinischen Stadium aktives, biopharmazeutisches Unternehmen und NeuroFront Therapeutics (Hong Kong) Limited, ein in China ansässiges Neurologie-Biotech-Unternehmen im klinischen Stadium, gaben gemeinsam die Unterzeichnung einer exklusiven Kooperations- und Vermarktungsvereinbarung für Novaremeds innovatives, nicht-opioides Prüfpräparat NRD.E1 bekannt, das für die Behandlung von diabetesbedingten neuropathischen Schmerzen und anderen neuropathischen Schmerzindikationen entwickelt wird. Die Vereinbarung sieht vor, dass Novaremed von NeuroFront über USD 130 Mio. an Options- und Ausübungsgebühren sowie Meilensteinzahlungen für Entwicklung, Zulassung und Umsatz sowie Tantiemen auf den Nettoumsatz erhält. VISCHER hat Novaremed AG in rechtlichen und steuerlichen Fragen im Zusammenhang mit dem Options- und Lizenzvertrag beraten.

Im Rahmen der Vereinbarung räumt Novaremed NeuroFront eine exklusive Option auf die Entwicklungs-, Vermarktungs- und Herstellungsrechte für NRD.E1 ein, Novaremeds erstem innovativen, nicht-opioiden Wirkstoffkandidaten zur Behandlung von neuropathischen Schmerzen. Die Vereinbarung erlaubt NeuroFront die Entwicklung und Vermarktung von NRD.E1 zur Behandlung der schmerzhaften diabetischen peripheren Neuropathie (PDPN) und anderer neuropathischer Schmerzindikationen im Grossraum China (einschließlich Festlandchina, Hongkong, Macao und Taiwan) und Singapur.

Team von VISCHER

Das Team von VISCHER bestand aus Christian Wyss (Partner, Corporate / M&A), Matthias Staehelin (Partner, Corporate / M&A), Vincent Reardon (Managing Associate, Corporate / M&A), Cédric Saladin (Associate, Corporate / M&A), Timothy Woodtli (Associate, Corporate / M&A), Nadia Tarolli (Partner, Tax) und Adrian Briner (Managing Associate, Tax).

Information der Novaremed AG über den Vertrag

Die Novaremed AG informierte wie folgt über den Vertrag:

Novaremed AG and NeuroFront Therapeutics (Hong Kong) Limited jointly announce the signing of 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. Under the terms of the agreement, Novaremed is eligible to receive from NeuroFront over USD 130 million 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 (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 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.

“We are very delighted collaborating with NeuroFront to advance our non-opioid neuropathic pain treatment for patients suffering from PDPN and other neuropathic pain indications in China. Currently, approved medications for PDPN provide inadequate pain relief and are associated with many intolerable side effects. Based on both preclinical and clinical data, we believe NRD.E1 has the potential to offer unique benefits and revolutionize the way PDPN is treated,” said Isaac Kobrin, MD, Executive Chairman of Novaremed. “NeuroFront’s development and commercial expertise and its focus on innovative CNS drugs is complementary to our expertise and an ideal fit for Novaremed.”

“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.”

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 (PDPN). Novaremed successfully completed three Phase 1 studies [1] and one double-blind, placebo-controlled Phase 2a dose-finding proof-of-concept study [2] 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 (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.


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