Novaremed Enters Into an Exclusive Option and License Agreement With NeuroFront for the Non-opioid Neuropathic Pain Treatment, NRD.E1, for Greater China and Singapore
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.
About NRD.E1 and the treatment of chronic pain
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.
About NeuroFront
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. NeuroFront was established by top-tier 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&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. For more information: www.neurofrontrx.com.
About Novaremed
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 (PDPN). The earlier stage pipeline addressing chronic neuropathic pain includes the development candidates MP-101 (Phase 2 stage), and MP-103 (preclinical stage), targeting the unmet medical need of prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN). Novaremed Ltd (Israel) and Metys Pharmaceuticals AG (Switzerland) are fully owned subsidiaries of Novaremed AG, domiciled in Basel (Switzerland). For more information: www.novaremed.com.
References
[1] Tiecke E., Rainisio M., Guentert T., Müller S., Hochman L., Kaplan E., Mangialaio S. (2022). First-in-human single-ascending-dose, multiple-dose and food interaction studies of NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy. Clinical Pharmacology in Drug Development (CPDD). (https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1103)
[2] Tiecke E., Rainisio M., Eisenberg E., Wainstein J., Kaplan E., Silverberg M., Hochman L., Mangialaio S. (2022). NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy – a randomized proof of concept study. European Journal of Pain. (https://onlinelibrary.wiley.com/doi/10.1002/ejp.1989)
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220721005391/en/
Contact information
Contact for Novaremed
Mark Altmeyer, Executive Member of the Board
mark.altmeyer@novaremed.com
Contact for NeuroFront
Bin Yao, VP of Operations and Commercialization
bin.yao@neurofrontrx.com
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release
H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation
Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release
Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private
Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding
Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår
V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release
V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust
Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release
Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo