Ensysce Biosciences Announces Strategic Partnership for the Development and Commercial Launch of PF614 and PF614-MPAR
Ensysce Biosciences (NASDAQ:ENSC) has announced a strategic partnership with a leading specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR drug products. The partnership includes a $10 million commitment and involves the manufacturer taking an equity position in Ensysce.
The collaboration will provide Ensysce with clinical trial material, drug products for regulatory submissions, and initial commercial batches. The partner will handle the complete manufacturing process, including packaging, labeling, and shipment. This partnership secures key Chemistry Manufacturing and Control (CMC) elements for the New Drug Application (NDA) submission, supporting the company's goal of achieving regulatory approval for their innovative pain relief solutions.
Ensysce Biosciences (NASDAQ:ENSC) ha annunciato una partnership strategica con un importante produttore di farmaci specializzati per lo sviluppo e il lancio commerciale dei prodotti farmacologici PF614 e PF614-MPAR. La collaborazione include un investimento di 10 milioni di dollari e prevede che il produttore assuma una posizione di equity in Ensysce.
La collaborazione fornirà a Ensysce materiale per studi clinici, prodotti farmacologici per le sottomissioni regolatorie e lotti commerciali iniziali. Il partner si occuperà dell'intero processo di produzione, compresi imballaggio, etichettatura e spedizione. Questa partnership garantisce elementi chiave di Chimica, Produzione e Controllo (CMC) per la sottomissione della Nuova Domanda di Farmaco (NDA), supportando l'obiettivo dell'azienda di ottenere l'approvazione regolatoria per le loro innovative soluzioni per il sollievo dal dolore.
Ensysce Biosciences (NASDAQ:ENSC) ha anunciado una asociación estratégica con un importante fabricante de medicamentos especializados para el desarrollo y lanzamiento comercial de los productos farmacéuticos PF614 y PF614-MPAR. La asociación incluye un compromiso de 10 millones de dólares y el fabricante tomará una posición de capital en Ensysce.
La colaboración proporcionará a Ensysce material para ensayos clínicos, productos farmacéuticos para presentaciones regulatorias y lotes comerciales iniciales. El socio se encargará de todo el proceso de fabricación, incluidos el empaque, el etiquetado y el envío. Esta asociación asegura elementos clave de Química, Fabricación y Control (CMC) para la presentación de la Nueva Solicitud de Medicamento (NDA), apoyando el objetivo de la empresa de obtener la aprobación regulatoria para sus innovadoras soluciones de alivio del dolor.
Ensysce Biosciences (NASDAQ:ENSC)는 전문 의약품 제조업체와의 전략적 파트너십을 발표하며 PF614 및 PF614-MPAR 의약품의 개발 및 상업적 출시를 추진합니다. 파트너십에는 1000만 달러의 약속이 포함되어 있으며, 제조업체는 Ensysce의 지분을 인수할 것입니다.
이번 협업은 Ensysce에 임상 시험 물질, 규제 제출을 위한 의약품 및 초기 상업적 배치를 제공할 예정입니다. 파트너는 포장, 라벨링 및 출하를 포함한 전체 제조 과정을 처리할 것입니다. 이 파트너십은 새로운 의약품 신청(NDA) 제출을 위한 핵심 화학, 제조 및 관리(CMC) 요소를 확보하여, 혁신적인 통증 완화 솔루션에 대한 규제 승인을 달성하려는 회사의 목표를 지원합니다.
Ensysce Biosciences (NASDAQ:ENSC) a annoncé un partenariat stratégique avec un important fabricant de médicaments spécialisés pour le développement et le lancement commercial des produits pharmaceutiques PF614 et PF614-MPAR. Le partenariat comprend un engagement de 10 millions de dollars et implique que le fabricant prenne une position en capital dans Ensysce.
La collaboration fournira à Ensysce des matériaux pour essais cliniques, des produits pharmaceutiques pour les soumissions réglementaires, et des lots commerciaux initiaux. Le partenaire s'occupera du processus de fabrication complet, y compris l'emballage, l'étiquetage et l'expédition. Ce partenariat sécurise des éléments clés de chimie, de fabrication et de contrôle (CMC) pour la soumission de la nouvelle demande de médicament (NDA), soutenant l'objectif de l'entreprise d'obtenir l'approbation réglementaire pour ses solutions innovantes de soulagement de la douleur.
Ensysce Biosciences (NASDAQ:ENSC) hat eine strategische Partnerschaft mit einem führenden Hersteller von Spezialmedikamenten für die Entwicklung und den kommerziellen Launch von PF614 und PF614-MPAR Arzneimitteln angekündigt. Die Partnerschaft umfasst ein Engagement von 10 Millionen Dollar und beinhaltet, dass der Hersteller eine Eigenkapitalposition bei Ensysce einnimmt.
Die Zusammenarbeit wird Ensysce mit klinischem Prüfmaterial, Arzneimitteln für regulatorische Einreichungen und ersten kommerziellen Chargen versorgen. Der Partner wird den gesamten Herstellungsprozess, einschließlich Verpackung, Etikettierung und Versand, übernehmen. Diese Partnerschaft sichert wichtige chemische, herstellungs- und kontrolltechnische (CMC) Elemente für die Einreichung der Neuen Arzneimittelanwendung (NDA) und unterstützt das Ziel des Unternehmens, eine regulatorische Genehmigung für ihre innovativen Schmerzlösungen zu erhalten.
- $10 million financial commitment secured from specialty drug manufacturer
- Strategic partnership includes manufacturer taking equity position in company
- Comprehensive manufacturing and distribution support secured for clinical trials and commercialization
- Partnership covers key CMC elements for NDA submission
- None.
Insights
This strategic partnership represents a significant milestone for Ensysce Biosciences, bringing in a
The partnership addresses two critical aspects: financial backing through equity investment and operational execution through manufacturing support. This significantly de-risks the commercialization pathway for PF614 and PF614-MPAR by securing the CMC components needed for FDA approval. The manufacturer's equity stake also demonstrates confidence in Ensysce's technology and aligns interests for long-term success.
The comprehensive nature of the agreement, covering everything from clinical trial materials to commercial production, should reduce capital requirements and accelerate time-to-market. This is particularly valuable given the company's small size and the competitive nature of the pain management market.
The development of PF614 and PF614-MPAR represents an important advancement in addressing the opioid crisis. These drug candidates are designed to provide effective pain relief while incorporating abuse-deterrent properties, a important feature in today's healthcare landscape. The manufacturing partnership is particularly significant as it ensures consistent quality and supply chain reliability for these specialized formulations.
Having a specialty drug manufacturer handle the complete manufacturing process, including the complex CMC requirements, significantly strengthens the regulatory submission package. This is especially important for novel opioid formulations, which face intense FDA scrutiny. The partner's expertise in specialty drug manufacturing could help navigate these regulatory challenges more effectively.
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SAN DIEGO, CA / ACCESSWIRE / December 4, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced the initiation of a strategic partnership with a leading specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR drug products.
This collaboration underscores a shared commitment to achieving swift regulatory approval and efficient development of the Company's innovative drug products. The strategic partnership will provide Ensysce with the clinical trial material, drug products for regulatory submissions, and initial commercial batches of PF614 and PF614-MPAR. The partner's services will also encompass the complete manufacturing process, including packaging, labeling, and shipment of the products, ensuring a seamless transition from regulatory approval to market entry.
As part of this partnership, the specialty drug manufacturer will take an equity position in Ensysce, facilitating resource allocation to clinical trials and commercialization activities. The agreement also secures key Chemistry Manufacturing and Control (CMC) elements of the New Drug Application (NDA) submission.
Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, stated, "This partnership strengthens our ability to deliver quality drug products for clinical and commercial purposes starting with PF614 and PF614-MPAR. It ensures that all aspects of manufacturing, packaging, and distribution are handled efficiently, enabling us to focus on helping patients suffering from severe pain with innovative and safer solutions."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage pharmaceutical company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP TM ) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
Forward-Looking Statements
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.
Ensysce Biosciences Company Contact
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196
Ensysce Biosciences Investor Relations Contact:
MZ Group North America
Shannon Devine
203-741-8811
ENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
View the original press release on accesswire.com
FAQ
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