NeuroSense Therapeutics Announces Successful Completion of Commercial Manufacturing Scale-Up for PrimeC in Preparation for Potential Canadian Market Launch
NeuroSense Therapeutics (NASDAQ: NRSN) has achieved a crucial milestone in its commercialization strategy by successfully scaling up the production of PrimeC, its potential ALS treatment, to commercial levels. The company has partnered with a global CDMO and implemented comprehensive CMC enhancements to ensure robust manufacturing infrastructure. Key achievements include:
- Qualification of U.S. and Canadian DMF and CEP holders for APIs
- Validation of analytical methods for drug product release and stability
- Confirmation of 36-month room-temperature shelf life
- Patent protection through 2042
NeuroSense is pursuing early market entry in Canada through the NOC/c pathway, with projected peak annual revenue of $100-150 million in the Canadian market. This follows promising efficacy data from the Phase 2b PARADIGM study.
NeuroSense Therapeutics (NASDAQ: NRSN) ha raggiunto un traguardo fondamentale nella sua strategia di commercializzazione, incrementando con successo la produzione di PrimeC, il suo potenziale trattamento per la SLA, fino a livelli commerciali. L'azienda ha collaborato con un CDMO globale e ha implementato miglioramenti completi nel CMC per garantire un'infrastruttura di produzione solida. I principali risultati includono:
- Qualifica dei titolari DMF e CEP negli Stati Uniti e Canada per gli API
- Validazione dei metodi analitici per il rilascio e la stabilità del prodotto farmaceutico
- Conferma di una durata di conservazione a temperatura ambiente di 36 mesi
- Protezione brevettuale fino al 2042
NeuroSense sta puntando a un ingresso anticipato nel mercato canadese tramite la procedura NOC/c, con un fatturato annuo massimo previsto tra 100 e 150 milioni di dollari nel mercato canadese. Questo segue dati promettenti di efficacia dallo studio di Fase 2b PARADIGM.
NeuroSense Therapeutics (NASDAQ: NRSN) ha alcanzado un hito crucial en su estrategia de comercialización al escalar con éxito la producción de PrimeC, su posible tratamiento para la ELA, a niveles comerciales. La compañía se ha asociado con un CDMO global y ha implementado mejoras integrales en CMC para garantizar una infraestructura de fabricación robusta. Los logros clave incluyen:
- Calificación de titulares de DMF y CEP en EE. UU. y Canadá para los API
- Validación de métodos analíticos para la liberación y estabilidad del producto farmacéutico
- Confirmación de una vida útil de 36 meses a temperatura ambiente
- Protección de patente hasta 2042
NeuroSense está buscando una entrada temprana al mercado canadiense a través de la vía NOC/c, con ingresos anuales máximos proyectados de 100 a 150 millones de dólares en el mercado canadiense. Esto sigue a datos prometedores de eficacia del estudio de Fase 2b PARADIGM.
NeuroSense Therapeutics (NASDAQ: NRSN)는 잠재적 ALS 치료제인 PrimeC의 상업적 생산 규모 확대에 성공하며 상업화 전략에서 중요한 이정표를 달성했습니다. 회사는 글로벌 CDMO와 협력하고 강력한 제조 인프라를 보장하기 위해 포괄적인 CMC 개선을 시행했습니다. 주요 성과는 다음과 같습니다:
- 미국 및 캐나다 DMF 및 CEP 보유자 자격 인증
- 의약품 출시 및 안정성 분석 방법 검증
- 실온에서 36개월 유효기간 확인
- 2042년까지 특허 보호
NeuroSense는 NOC/c 경로를 통해 캐나다 시장에 조기 진입을 추진 중이며, 캐나다 시장에서 연간 최고 매출 1억~1억 5천만 달러를 예상하고 있습니다. 이는 2b상 PARADIGM 연구의 유망한 효능 데이터에 따른 것입니다.
NeuroSense Therapeutics (NASDAQ : NRSN) a franchi une étape cruciale dans sa stratégie de commercialisation en réussissant à augmenter la production de PrimeC, son traitement potentiel contre la SLA, à un niveau commercial. L'entreprise s'est associée à un CDMO mondial et a mis en œuvre des améliorations complètes du CMC pour garantir une infrastructure de fabrication solide. Les principales réalisations comprennent :
- Qualification des titulaires de DMF et CEP aux États-Unis et au Canada pour les API
- Validation des méthodes analytiques pour la libération et la stabilité du produit médicamenteux
- Confirmation d'une durée de conservation de 36 mois à température ambiante
- Protection par brevet jusqu'en 2042
NeuroSense vise une entrée précoce sur le marché canadien via la voie NOC/c, avec un chiffre d'affaires annuel maximal prévu entre 100 et 150 millions de dollars sur le marché canadien. Cela fait suite à des données d'efficacité prometteuses issues de l'étude de Phase 2b PARADIGM.
NeuroSense Therapeutics (NASDAQ: NRSN) hat einen wichtigen Meilenstein in seiner Kommerzialisierungsstrategie erreicht, indem es die Produktion von PrimeC, seiner potenziellen ALS-Behandlung, erfolgreich auf kommerzielles Niveau hochgefahren hat. Das Unternehmen hat eine Partnerschaft mit einem globalen CDMO geschlossen und umfassende CMC-Verbesserungen umgesetzt, um eine robuste Produktionsinfrastruktur sicherzustellen. Zu den wichtigsten Errungenschaften gehören:
- Qualifizierung von DMF- und CEP-Inhabern in den USA und Kanada für Wirkstoffe
- Validierung analytischer Methoden für die Freigabe und Stabilität des Arzneimittels
- Bestätigung einer Haltbarkeit von 36 Monaten bei Raumtemperatur
- Patentschutz bis 2042
NeuroSense verfolgt einen frühen Markteintritt in Kanada über den NOC/c-Weg mit einem prognostizierten Spitzenumsatz von 100 bis 150 Millionen US-Dollar im kanadischen Markt. Dies folgt auf vielversprechende Wirksamkeitsdaten aus der Phase-2b-Studie PARADIGM.
- Successfully scaled up PrimeC production to commercial levels
- Secured 36-month room-temperature shelf life stability
- Patent protection extends through 2042
- Projected peak annual revenue of $100-150M in Canadian market
- Established dual-source supply chain with U.S. and Canadian API suppliers
- Still pending regulatory approval from Health Canada
- Limited initial market focus on Canada only
Insights
NeuroSense achieves commercial manufacturing scale-up for ALS drug PrimeC, targeting $100-150M Canadian market with regulatory pathway discussions underway.
NeuroSense has achieved a significant operational milestone by successfully scaling up manufacturing of PrimeC to commercial levels. This preparation positions the company to potentially enter the Canadian ALS treatment market, which they project could reach
The technical aspects of this achievement are noteworthy. The company has secured a global Contract Development and Manufacturing Organization (CDMO) partner that's already producing their clinical batches, ensuring manufacturing continuity. All analytical methods for product release and stability testing have been fully validated - a critical requirement for regulatory submissions. The confirmed 36-month room-temperature shelf life is particularly important for a specialized medication like PrimeC, as it simplifies distribution logistics and improves access for patients with Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease affecting motor neurons.
The company is pursuing Canada's Notice of Compliance with Conditions (NOC/c) pathway, which can expedite market access for treatments addressing serious conditions with significant unmet needs. This regulatory strategy appears designed to generate real-world evidence while establishing commercial operations before potential expansion to larger markets. Their formulation intellectual property protection extends until 2042, providing substantial runway for commercialization if approved.
This manufacturing readiness demonstrates operational execution toward commercialization following their Phase 2b PARADIGM study, though regulatory approval remains the critical next milestone. For a late-stage biotech company, establishing commercial manufacturing capabilities represents essential preparation but is just one component of the path to market.
NeuroSense Announces Global CDMO Selection and Manufacturing Scale-Up, Enabling Rapid Pathway to Commercialization for What is Projected to be a
NeuroSense has strategically bolstered its supply chain by implementing comprehensive Chemistry, Manufacturing, and Controls (CMC) enhancements that positions the company for a robust and expeditious commercial launch. The company has established a resilient manufacturing infrastructure supply chain by fully qualifying
Additionally, the Company is pleased to report that it is partnering with a global Contract Development and Manufacturing Organization (CDMO) that currently manufactures PrimeC clinical batches and will also support its future commercial supply. All analytical methods supporting drug product release and stability have been fully validated, and the manufacturing process has been successfully scaled to commercial levels. Stability data support a shelf life of at least 36 months at room temperature, and formulation IP granted in 2023 provides protection through 2042.
"This manufacturing milestone represents a critical leap forward in our commercialization roadmap," said Alon Ben-Noon, CEO of NeuroSense. "With commercial-scale production validated and a 36-month room-temperature shelf life confirmed, PrimeC is now positioned to rapidly enter the Canadian market upon regulatory approval. This achievement, coupled with our patent protection through 2042, strengthens our ability to deliver PrimeC to ALS patients who urgently need new therapeutic options."
NeuroSense is actively working to advance discussions with Health Canada to pursue early market entry through the Notice of Compliance with Conditions (NOC/c) pathway, a regulatory mechanism designed to expedite access to promising therapies for serious conditions with significant unmet medical needs. While commercial forecasts suggest potential peak annual revenue of
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 that target multiple pathological 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 statements regarding a commercial launch in
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