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Argent BioPharma Enters Germany - Europe's Largest Market

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Argent BioPharma (ASX: RGT, OTCQB: RGTLF) has announced its entry into the German pharmaceutical market, securing initial purchase orders for CannEpil® and CogniCann® following regulatory approval. Germany, being Europe's largest healthcare market, represents a significant commercial milestone for the company's European expansion strategy.

The clinical-stage biopharmaceutical company has also completed the transfer of its EU GMP-certified manufacturing facilities in Slovenia and Malta to third-party operators. This operational restructuring is expected to generate annual cost savings of over $1 million while maintaining GMP compliance. The freed capital will be directed towards accelerating R&D initiatives and clinical trials across core therapeutic programs.

Argent BioPharma (ASX: RGT, OTCQB: RGTLF) ha annunciato il suo ingresso nel mercato farmaceutico tedesco, assicurandosi i primi ordini di acquisto per CannEpil® e CogniCann® dopo l'approvazione normativa. La Germania, essendo il più grande mercato sanitario d'Europa, rappresenta un traguardo commerciale significativo per la strategia di espansione europea dell'azienda.

La società biofarmaceutica in fase clinica ha inoltre completato il trasferimento dei suoi stabilimenti produttivi certificati EU GMP in Slovenia e Malta a operatori terzi. Questa ristrutturazione operativa dovrebbe generare risparmi annui superiori a 1 milione di dollari, mantenendo la conformità GMP. Il capitale liberato sarà destinato ad accelerare le iniziative di R&S e le sperimentazioni cliniche nei programmi terapeutici principali.

Argent BioPharma (ASX: RGT, OTCQB: RGTLF) ha anunciado su entrada en el mercado farmacéutico alemán, asegurando los primeros pedidos de compra de CannEpil® y CogniCann® tras la aprobación regulatoria. Alemania, siendo el mayor mercado sanitario de Europa, representa un hito comercial importante para la estrategia de expansión europea de la compañía.

La empresa biofarmacéutica en etapa clínica también ha completado la transferencia de sus instalaciones de fabricación certificadas EU GMP en Eslovenia y Malta a operadores externos. Esta reestructuración operativa se espera que genere ahorros anuales superiores a 1 millón de dólares, manteniendo el cumplimiento de GMP. El capital liberado se destinará a acelerar las iniciativas de I+D y los ensayos clínicos en los programas terapéuticos principales.

Argent BioPharma (ASX: RGT, OTCQB: RGTLF)는 규제 승인 후 CannEpil® 및 CogniCann®의 초기 구매 주문을 확보하며 독일 제약 시장에 진출했다고 발표했습니다. 독일은 유럽 최대의 의료 시장으로, 회사의 유럽 확장 전략에 중요한 상업적 이정표를 의미합니다.

임상 단계의 바이오제약 회사인 이 회사는 또한 슬로베니아와 몰타에 있는 EU GMP 인증 제조 시설을 제3자 운영자에게 이전을 완료했습니다. 이 운영 구조 조정은 GMP 준수를 유지하면서 연간 100만 달러 이상의 비용 절감을 기대하고 있습니다. 확보된 자본은 핵심 치료 프로그램의 연구개발 및 임상 시험 가속화에 투입될 예정입니다.

Argent BioPharma (ASX : RGT, OTCQB : RGTLF) a annoncé son entrée sur le marché pharmaceutique allemand, obtenant les premières commandes d'achat pour CannEpil® et CogniCann® après l'approbation réglementaire. L'Allemagne, plus grand marché de la santé en Europe, représente une étape commerciale majeure dans la stratégie d'expansion européenne de l'entreprise.

La société biopharmaceutique en phase clinique a également finalisé le transfert de ses sites de production certifiés EU GMP en Slovénie et à Malte vers des opérateurs tiers. Cette restructuration opérationnelle devrait générer des économies annuelles supérieures à 1 million de dollars tout en maintenant la conformité GMP. Les fonds libérés seront investis pour accélérer les initiatives de R&D et les essais cliniques dans les programmes thérapeutiques clés.

Argent BioPharma (ASX: RGT, OTCQB: RGTLF) hat seinen Eintritt in den deutschen Pharmamarkt bekannt gegeben und erste Bestellungen für CannEpil® und CogniCann® nach behördlicher Zulassung gesichert. Deutschland, als größter Gesundheitsmarkt Europas, stellt einen bedeutenden kommerziellen Meilenstein für die europäische Expansionsstrategie des Unternehmens dar.

Das biopharmazeutische Unternehmen in der klinischen Entwicklungsphase hat zudem die Übertragung seiner EU-GMP-zertifizierten Produktionsanlagen in Slowenien und Malta an Drittanbieter abgeschlossen. Diese operative Umstrukturierung soll jährliche Kosteneinsparungen von über 1 Million US-Dollar ermöglichen und gleichzeitig die GMP-Konformität gewährleisten. Das freigesetzte Kapital wird zur Beschleunigung von F&E-Initiativen und klinischen Studien in den Kerntherapieprogrammen verwendet.

Positive
  • Entry into Germany, Europe's largest healthcare market
  • Secured initial purchase orders for CannEpil® and CogniCann®
  • Over $1 million annual cost savings from manufacturing facilities transfer
  • Maintained GMP compliance while reducing infrastructure overhead
Negative
  • Divestment of manufacturing control through transfer to third-party operators

Strategic Expansion Paired with Over $1M in Annual Cost Savings from Operational Restructuring

PERTH, Australia, April 23, 2025 /PRNewswire/ -- Argent BioPharma Ltd. (ASX: RGT) (OTCQB: RGTLF), a clinical-stage biopharmaceutical company specializing in neuroimmune therapies, is pleased to announce its official entry into the German pharmaceutical market with the receipt of initial purchase orders for CannEpil® and CogniCann®, following recent regulatory approval. Germany, as the largest healthcare market in Europe, represents a significant commercial milestone and a strategic beachhead for Argent's broader European expansion.

In parallel, the Company has successfully completed the transfer of its EU GMP-certified manufacturing facilities in Slovenia and Malta to trusted third-party operators. This strategic operational shift allows Argent to maintain GMP compliance while reducing infrastructure overhead, resulting in annual operational cost savings exceeding USD $1 million. These efficiencies free up capital to further accelerate R&D initiatives and clinical trials across core therapeutic programs.

These achievements reflect Argent BioPharma's broader transformation strategy—centered on fully proprietary, neuroimmune drug development, in-house innovation, and sustainable global scalability. The Company remains focused on advancing its therapeutic pipeline while deepening market penetration across high-value regions.

About Argent BioPharma
Argent BioPharma Ltd. (ASX: RGT) develops proprietary therapeutics targeting central nervous system (CNS) and autoimmune disorders using its Neuro-Immune Modulatory (NIM) platform. Lead assets include CannEpil®, CogniCann®, and CimetrA®, which are now entering major European markets as part of a targeted international growth plan.

Contact:
Roby Zomer
CEO & Managing Director
+61 8 6555 2950
info@argentbiopharma.com

Rowan Harland
Company Secretary
+61 8 6555 2950
info@argentbiopharma.com

Cision View original content:https://www.prnewswire.com/news-releases/argent-biopharma-enters-germany--europes-largest-market-302435972.html

SOURCE Argent BioPharma Ltd.

FAQ

What is the expected annual cost savings for Argent BioPharma (RGTLF) from its operational restructuring?

Argent BioPharma expects to achieve annual operational cost savings exceeding USD $1 million through the transfer of its EU GMP-certified manufacturing facilities to third-party operators.

Which products has Argent BioPharma (RGTLF) received purchase orders for in Germany?

Argent BioPharma has received initial purchase orders for CannEpil® and CogniCann® in the German market.

How will RGTLF use the cost savings from its manufacturing facilities transfer?

The cost savings will be used to accelerate R&D initiatives and clinical trials across core therapeutic programs.

Which manufacturing facilities has Argent BioPharma (RGTLF) transferred to third-party operators?

Argent BioPharma has transferred its EU GMP-certified manufacturing facilities in Slovenia and Malta to third-party operators.
Argent BioPharma

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