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
21.7.2022 10:58:00 EEST | Business Wire | Press release
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
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Oscilloquartz delivers assured timing for mission-critical harsh environments with ruggedSync ™ Series OSA 55101.6.2026 15:00:00 EEST | Press release
Oscilloquartz today launched its ruggedSync™ Series OSA 5510, a ruggedized timing and synchronization platform engineered for defense and other harsh, mission-critical environments. Designed for deployment in tactical communications networks, mobile command centers (MCCs), aviation systems and other highly demanding operational environments, the OSA 5510 combines PTP grandmaster and NTP server functionality with synchronization assurance and resilient holdover in a compact MIL-qualified platform. Multi-band GNSS support, encrypted and authenticated timing options and environmental protection enable operation in contested and GNSS-denied environments where trusted synchronization must be maintained. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601763766/en/ Oscilloquartz’s ruggedSync™ Series OSA 5510 delivers resilient, high-precision timing for mission-critical defense networks. “Our new ruggedSync™ Series OSA 5510 exte
Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy1.6.2026 15:00:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) submission for povetacicept, an investigational engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in adults with immunoglobulin A nephropathy (IgAN). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. If approved, povetacicept will become the first commercialized therapy in Vertex’s emerging nephrology franchise. “The Phase 3 RAINIER trial is the largest conducted in IgAN and achieved full enrollment faster than any contemporary IgAN trial, reflecting the significant unmet need in IgAN and our urgency to bring povetacicept to patients with this serious disease,” said Nia Tatsis, Ph.D., Executive Vice President and Chief Regulatory and Quality Officer at Vertex. “With today’s FDA accepta
Winston Taylor Completes Historic Transatlantic Combination1.6.2026 14:01:00 EEST | Press release
Winston Taylor announces today that Winston & Strawn and Taylor Wessing’s U.K.-led business have officially launched as a single combined firm, creating a premier transatlantic law firm built for the needs of the businesses, people, and markets driving capital and innovation. One of the largest transatlantic firms, with more than 1,400 lawyers spanning the United States, the United Kingdom, Europe, Latin America, and the Middle East, Winston Taylor is built to meet clients’ evolving global needs for counsel. “As Winston Taylor, we are centered on a client-first approach and will be working shoulder to shoulder with our clients at the cutting edge of industry and ingenuity,” said Chairman Steve D’Amore. “With that common purpose, we are leveraging both strength and scale by integrating our teams and offices at record speed, working at pace to create a firm that is aligned, focused, and built for the day-to-day needs of our clients as well as their breakthrough moments.” Winston Taylor o
Kinaxis Appoints Kristin Russel as Chief Marketing Officer1.6.2026 14:00:00 EEST | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced the appointment of Kristin Russel as Chief Marketing Officer (CMO). Russel will lead Kinaxis’ global marketing organization, overseeing marketing strategy, corporate and market positioning, digital and brand marketing, communications and go-to-market initiatives. Russel will also take the main stage at Kinexions, where she will discuss practical steps organizations can take to move from decisions to outcomes in an increasingly complex operating environment. A tenured marketing executive and recognized industry leader, Russel brings deep experience scaling technology companies and building high impact brands. She joins Kinaxis from symplr, where she served as Chief Marketing Officer and led the development and execution of the company’s comprehensive marketing strategy across branding, digital and product marketing, public relations, community outreach programs, channel partne
Samsung Electronics Begins Shipment of Industry-First HBM4E Samples1.6.2026 13:57:00 EEST | Press release
Samsung Electronics, a global leader in advanced memory technology, has begun shipping the industry's first 12-layer HBM4E samples to major global customers, further strengthening its leadership in the next-generation HBM market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601979564/en/ Samsung's 12-layer HBM4E Following the industry’s first mass production and commercial shipment of its industry-leading HBM4 earlier this year, Samsung now extends its HBM roadmap with the introduction of HBM4E samples, addressing the rapidly evolving demands of AI computing and hyperscale infrastructure. "Following the successful mass production of HBM4, Samsung has once again demonstrated its distinct technological edge with HBM4E," said Sang Joon Hwang, Executive Vice President and Head of Memory Development at Samsung Electronics. "Through our advanced manufacturing capabilities and preemptive infrastructure investments, we will con
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom