NeuroSense Therapeutics Enters Binding Term Sheet to Advance PrimeC for ALS
NeuroSense Therapeutics (NRSN) has entered into a binding term sheet with a leading global pharmaceutical company for its ALS treatment drug PrimeC. The agreement includes a substantial upfront payment, funding for Phase 3 clinical trials, milestone payments, and tiered double-digit royalties on annual net sales. The pharmaceutical company will receive exclusive rights to distribute, market, promote, and sell PrimeC in certain key territories, while NeuroSense retains rights in other key markets.
PrimeC is a fixed-dose combination of two FDA-approved drugs, designed to target multiple ALS disease pathways. The company's Phase 2b PARADIGM trial has shown positive safety and efficacy results. The definitive agreement is expected to be finalized in Q1 2025.
NeuroSense Therapeutics (NRSN) ha firmato un accordo vincolante con una importante azienda farmaceutica globale per il suo farmaco per il trattamento della SLA, PrimeC. L'accordo comprende un sostanziale pagamento iniziale, finanziamenti per le sperimentazioni cliniche di Fase 3, pagamenti legati ai traguardi e royalties a doppia cifra su vendite nette annuali. L'azienda farmaceutica avrà diritti esclusivi per distribuire, commercializzare, promuovere e vendere PrimeC in alcuni territori chiave, mentre NeuroSense manterrà i diritti in altri mercati importanti.
PrimeC è una combinazione a dose fissa di due farmaci approvati dalla FDA, progettata per colpire diversi percorsi della malattia SLA. La sperimentazione PARADIGM di Fase 2b dell'azienda ha mostrato risultati positivi in termini di sicurezza e efficacia. Si prevede che l’accordo definitivo sarà finalizzato nel primo trimestre del 2025.
NeuroSense Therapeutics (NRSN) ha firmado un acuerdo vinculante con una destacada empresa farmacéutica global para su fármaco de tratamiento de la ELA, PrimeC. El acuerdo incluye un importante pago inicial, financiación para ensayos clínicos de Fase 3, pagos por hitos y regalías de dos dígitos escalonadas sobre las ventas netas anuales. La empresa farmacéutica recibirá derechos exclusivos para distribuir, comercializar, promover y vender PrimeC en ciertos territorios clave, mientras que NeuroSense retiene derechos en otros mercados importantes.
PrimeC es una combinación de dosis fija de dos medicamentos aprobados por la FDA, diseñada para atacar múltiples vías de la enfermedad ELA. El ensayo PARADIGM de Fase 2b de la empresa ha mostrado resultados positivos en seguridad y eficacia. Se espera que el acuerdo definitivo se finalice en el primer trimestre de 2025.
NeuroSense Therapeutics (NRSN)는 ALS 치료 약물 PrimeC의 개발을 위해 세계적 선도 제약회사와 구속력 있는 협약을 체결했습니다. 이 계약에는 상당한 초기 지급금, 3상 임상 시험을 위한 자금, 이정표 지급금, 연간 순매출에 대한 이중 자릿수 비율의 단계적 로열티가 포함되어 있습니다. 제약회사는 특정 주요 지역에서 PrimeC를 독점적으로 배급, 마케팅, 홍보 및 판매할 권리를 가지며, NeuroSense는 다른 주요 시장에서의 권리를 유지합니다.
PrimeC는 두 가지 FDA 승인 약물의 고정 복합 체제로, ALS 질병의 여러 경로를 겨냥하도록 설계되었습니다. 회사의 2b 단계 PARADIGM 시험은 긍정적인 안전성 및 효능 결과를 나타냈습니다. 최종 계약은 2025년 1분기 내에 완료될 것으로 예상됩니다.
NeuroSense Therapeutics (NRSN) a conclu une convention contraignante avec une entreprise pharmaceutique mondiale de premier plan pour son médicament de traitement de la SLA, PrimeC. L'accord inclut un paiement initial substantiel, un financement pour les essais cliniques de Phase 3, des paiements d'étape et des redevances à deux chiffres échelonnées sur les ventes nettes annuelles. L'entreprise pharmaceutique recevra des droits exclusifs pour distribuer, commercialiser, promouvoir et vendre PrimeC dans certains territoires clés, tandis que NeuroSense conserve des droits dans d'autres marchés importants.
PrimeC est une combinaison à dose fixe de deux médicaments approuvés par la FDA, conçue pour cibler plusieurs voies de la maladie SLA. L'essai PARADIGM de Phase 2b de la société a montré des résultats positifs en termes de sécurité et d'efficacité. L'accord définitif devrait être finalisé au premier trimestre 2025.
NeuroSense Therapeutics (NRSN) hat ein verbindliches Vertragsangebot mit einem führenden globalen Pharmaunternehmen für sein ALS-Behandlungsmedikament PrimeC abgeschlossen. Die Vereinbarung umfasst eine beträchtliche Vorauszahlung, Finanzierung für klinische Studien der Phase 3, Meilensteinzahlungen und gestaffelte zweistellige Tantiemen auf die jährlichen Nettoumsätze. Das Pharmaunternehmen erhält exklusive Rechte für den Vertrieb, das Marketing, die Werbung und den Verkauf von PrimeC in bestimmten Schlüsselgebieten, während NeuroSense die Rechte in anderen wichtigen Märkten behält.
PrimeC ist eine Fixdosis-Kombination aus zwei von der FDA zugelassenen Medikamenten, die darauf abzielt, mehrere Krankheitswege der ALS zu bekämpfen. Die Phase 2b PARADIGM-Studie des Unternehmens hat positive Ergebnisse hinsichtlich Sicherheit und Wirksamkeit gezeigt. Der endgültige Vertrag wird voraussichtlich im ersten Quartal 2025 abgeschlossen sein.
- Secured substantial upfront payment and Phase 3 trial funding from a major pharmaceutical company
- Agreement includes milestone payments and double-digit royalties on net sales
- Phase 2b PARADIGM trial demonstrated positive safety and efficacy results
- Retained rights to PrimeC in certain key territories while partnering for others
- Final agreement not yet secured, pending definitive agreement in Q1 2025
- Specific financial terms and territory details not disclosed
Insights
The deal structure includes three critical value-driving components:
- Substantial upfront payment to strengthen the balance sheet
- Fully funded Phase 3 trial, eliminating major capital requirements
- Double-digit royalties providing significant commercial upside
For a microcap biotech with a
PrimeC's unique approach of combining two FDA-approved drugs with enhanced bioavailability represents an intelligent drug development strategy. The synergistic targeting of multiple ALS pathways addresses the complex nature of neurodegeneration, potentially offering superior efficacy compared to single-target approaches.
The positive Phase 2b safety and efficacy data, coupled with the pharmaceutical company's commitment, suggests PrimeC could become a significant advancement in ALS treatment. The current ALS therapeutic landscape is , with only a handful of approved treatments showing modest benefits. A successful Phase 3 trial could position PrimeC as a leading therapy option for this devastating disease.
The binding term sheet structure indicates sophisticated deal-making, balancing risk and reward between parties. The tiered royalty structure with double-digit percentages suggests strong negotiating leverage, likely driven by compelling IP protection and clinical data. While subject to definitive agreement, the binding nature provides significant legal framework and commitment.
Retaining territorial rights while securing development funding demonstrates strategic foresight in maintaining long-term value potential. The Q1 2025 timeline for definitive agreement allows adequate due diligence and detailed term negotiation, reducing execution risk. The non-exclusive research and manufacturing rights maintain operational flexibility while protecting core commercial interests.
- Binding Term Sheet with a leading global pharmaceutical company includes a substantial upfront payment and funding for the Phase 3 study
- Additionally, milestone payments and double-digit royalties on annual net sales
- The transaction is subject to finalization of a definitive agreement, anticipated in Q1 2025
The binding term sheet outlines substantial financial terms from the pharmaceutical company, including:
- A substantial upfront payment upon signing a definitive agreement,
- Funding for the Phase 3 clinical trial,
- Regulatory and net sales milestone payments, and
- A tiered royalty structure reaching double-digit percentage on annual net sales.
The binding term sheet is subject to finalization of a definitive agreement, anticipated in the first quarter of 2025.
The pharmaceutical company would have an exclusive license to distribute, market, promote, sell and develop PrimeC for ALS in certain key markets, and non-exclusive rights for research and manufacturing for PrimeC for ALS, subject to terms and conditions in the definitive agreement.
PrimeC is a proprietary fixed-dose combination of two FDA-approved drugs, uniquely formulated to enhance bioavailability and provide synergistic effects that target multiple ALS disease pathways. Results from NeuroSense's Phase 2b PARADIGM clinical trial demonstrated positive safety and efficacy, strengthening confidence in its potential to address the urgent unmet medical need in ALS.
About ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the
About PARADIGM
PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in
During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation.
Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.
About PrimeC
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include the terms of license and timing of a definitive agreement or if a definitive agreement is executed at all. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that a definitive agreement of the license to the global pharmaceutical company will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that contemplated license agreement, if executed, will not lead to the current anticipated benefits to NeuroSense, the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in
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SOURCE NeuroSense
FAQ
What are the key terms of NeuroSense's (NRSN) PrimeC licensing agreement?
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