Adial Pharmaceuticals Secures U.S.-Based Manufacturing Through Agreements with Cambrex and Thermo Fisher Scientific for Drug Substance and Drug Product Supply
Adial Pharmaceuticals (NASDAQ: ADIL) has secured strategic manufacturing agreements with Cambrex and Thermo Fisher Scientific for the production of AD04 (0.33 mg ondansetron tablets), its lead drug candidate for Alcohol Use Disorder (AUD). Cambrex will supply the ondansetron HCL drug substance, while Thermo Fisher will handle drug product manufacturing.
The agreements cover manufacturing for upcoming Phase 3 clinical trials and New Drug Application (NDA) submission to the FDA, including demonstration, clinical, registration, and validation batches. The collaboration has already yielded results with the completion of required demonstration batches.
Adial Pharmaceuticals (NASDAQ: ADIL) ha stipulato accordi strategici di produzione con Cambrex e Thermo Fisher Scientific per la realizzazione di AD04 (compresse da 0,33 mg di ondansetron), il suo principale candidato farmaco per il Disturbo da Uso di Alcol (AUD). Cambrex fornirà la sostanza attiva ondansetron HCL, mentre Thermo Fisher si occuperà della produzione del prodotto farmaceutico.
Gli accordi riguardano la produzione per i prossimi studi clinici di Fase 3 e la presentazione della New Drug Application (NDA) alla FDA, includendo batch di dimostrazione, clinici, di registrazione e di convalida. La collaborazione ha già portato risultati con il completamento dei batch di dimostrazione richiesti.
Adial Pharmaceuticals (NASDAQ: ADIL) ha asegurado acuerdos estratégicos de fabricación con Cambrex y Thermo Fisher Scientific para la producción de AD04 (tabletas de ondansetrón de 0,33 mg), su principal candidato a medicamento para el Trastorno por Consumo de Alcohol (AUD). Cambrex suministrará la sustancia activa ondansetrón HCL, mientras que Thermo Fisher se encargará de la fabricación del producto farmacéutico.
Los acuerdos cubren la fabricación para los próximos ensayos clínicos de Fase 3 y la presentación de la Solicitud de Nuevo Medicamento (NDA) a la FDA, incluyendo lotes de demostración, clínicos, de registro y de validación. La colaboración ya ha dado frutos con la finalización de los lotes de demostración requeridos.
Adial Pharmaceuticals (NASDAQ: ADIL)는 알코올 사용 장애(AUD) 치료제 후보인 AD04(0.33mg 온단세트론 정제) 생산을 위해 Cambrex와 Thermo Fisher Scientific과 전략적 제조 계약을 체결했습니다. Cambrex는 온단세트론 HCL 원료 의약품을 공급하며, Thermo Fisher는 완제 의약품 제조를 담당합니다.
이 계약은 다가오는 3상 임상시험 및 FDA에 제출할 신약 신청서(NDA)용 제조를 포함하며, 시연, 임상, 등록, 검증 배치 생산을 포함합니다. 이미 시연 배치 완료를 통해 협력 성과를 내고 있습니다.
Adial Pharmaceuticals (NASDAQ : ADIL) a conclu des accords stratégiques de fabrication avec Cambrex et Thermo Fisher Scientific pour la production d'AD04 (comprimés d'ondansétron de 0,33 mg), son principal candidat médicament pour le trouble lié à l'usage d'alcool (AUD). Cambrex fournira la substance active ondansétron HCL, tandis que Thermo Fisher prendra en charge la fabrication du produit pharmaceutique.
Ces accords couvrent la fabrication pour les prochains essais cliniques de phase 3 et la soumission de la demande de nouveau médicament (NDA) à la FDA, incluant les lots de démonstration, cliniques, d'enregistrement et de validation. La collaboration a déjà porté ses fruits avec l'achèvement des lots de démonstration requis.
Adial Pharmaceuticals (NASDAQ: ADIL) hat strategische Herstellungsvereinbarungen mit Cambrex und Thermo Fisher Scientific für die Produktion von AD04 (0,33 mg Ondansetron-Tabletten), ihrem führenden Wirkstoffkandidaten für Alkoholgebrauchsstörung (AUD), abgeschlossen. Cambrex wird den Wirkstoff Ondansetron HCL liefern, während Thermo Fisher die Herstellung des Arzneimittels übernimmt.
Die Vereinbarungen umfassen die Herstellung für bevorstehende Phase-3-Studien und die Einreichung des New Drug Application (NDA) bei der FDA, einschließlich Demonstrations-, klinischer, Registrierungs- und Validierungschargen. Die Zusammenarbeit hat bereits erste Erfolge mit dem Abschluss der erforderlichen Demonstrationschargen erzielt.
- Strategic partnerships secured with established US-based manufacturers Cambrex and Thermo Fisher
- Manufacturing agreements cover both clinical trials and NDA submission requirements
- Demonstration batches already completed, showing immediate progress
- US-based manufacturing helps avoid potential tariff implications
- None.
Insights
Adial secures critical manufacturing partnerships with Cambrex and Thermo Fisher for AD04, demonstrating tangible progress toward Phase 3 trials and FDA submission.
Adial's manufacturing agreements with Cambrex and Thermo Fisher Scientific represent a significant operational milestone in the development of AD04 for Alcohol Use Disorder (AUD). These partnerships establish a complete supply chain infrastructure covering both drug substance (ondansetron HCl from Cambrex) and drug product (0.33 mg tablets from Thermo Fisher) manufacturing for the upcoming Phase 3 registrational trials and eventual NDA submission.
The selection of US-based manufacturers demonstrates strategic foresight, particularly considering potential tariff implications that could affect pharmaceutical supply chains. Both partners are established CDMOs with proven track records, which reduces execution risk in the critical CMC (Chemistry, Manufacturing, and Controls) component of the regulatory pathway.
What's particularly notable is the company's report that demonstration batches – a prerequisite for registration and clinical batches – are already in progress. This suggests the manufacturing process development is advancing on schedule, which is crucial for maintaining the timeline to initiation of the planned Phase 3 program.
For a clinical-stage biopharmaceutical company, securing reliable manufacturing is a fundamental requirement before conducting pivotal trials. The agreements signal that Adial is methodically addressing the operational foundations needed for late-stage clinical development of AD04, their lead candidate targeting AUD in genetically-identified heavy drinking patients. These manufacturing partnerships are tangible evidence of the company's transition from early development toward potential commercialization.
Scope of Agreement with Cambrex to Provide Ondansetron HCL Drug Substance Under FDA Approved Drug Master File
Scope Of Agreement With Thermo Fisher to Provide Manufacturing Services Including Demonstration, Clinical, Registration And Validation Batches of AD04 for US Clinical Trials And NDA Submission
GLEN ALLEN, Va., June 25, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the recent execution of agreements for the production of AD04 (0.33 mg ondansetron tablets), supporting both the completion of upcoming clinical trials and the planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the treatment of Alcohol Use Disorder (AUD) in the US. AD04 is the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients.
The strategic collaboration with Thermo Fisher Scientific as the Contract Development and Manufacturing Organization (CDMO) for AD04 Drug Product, and Cambrex, a drug substance CDMO and supplier of Ondansetron API, has begun and is already seeing results in completion of the demonstration batches required prior to the conduct of the registration and clinical batches. The importance of choosing CDMOs with both drug substance development and manufacturing capabilities with successful track records was a key element to the signing of the agreements. The agreements include all phases of manufacturing for both the clinical supplies needed to conduct the upcoming clinical studies for AD04, as well as the Chemistry, Manufacturing, and Controls (CMC) module documentation required for the submission of the NDA to the FDA.
Cary Claiborne, President and Chief Executive Officer of Adial commented, “As our readiness in planning the future Phase 3 registrational study program for AD04 continues, these agreements with Thermo Fisher and Cambrex are another key component in our planning for the upcoming conduct of the AD04 clinical trial program and to meet our requirements for the FDA. The combination of Thermo Fisher and Cambrex makes for a strong collaboration for Adial in our quest to develop AD04 for the treatment of AUD. Choosing a contract manufacturer which can meet our timelines for starting the clinical program is paramount. It was important for the CDMOs to be on sound financial footing, but also to have drug substance manufacturing as well as drug product manufacturing in the US to meet the eventual commercial demands of AD04 given recent tariff implications for our industry. It is equally important to have confidence in the drug substance manufacturer and their ability to consistently supply the needs of Adial. We believe these relationships will be invaluable as we move forward with the initiation of our Phase 3 trials.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.
About Cambrex Corporation
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. For more information, please visit www.cambrex.com
For more information, please visit www.cambrex.com
Forward-Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the upcoming clinical trials and the planned NDA submission to the FDA for the treatment of AUD in the US, developing AD04 for the treatment of AUD, meeting the eventual commercial demands of AD04, the relationships with CDMOs being invaluable the Company moves forward with the initiation of Phase 3 trials and the potential of AD04 to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com
FAQ
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