PharmaTher Provides Corporate Update on Ketamine Development and Commercial Strategy
PharmaTher Holdings (OTCQB: PHRRF) has announced strategic updates following the sale of its Ketamine Hydrochloride Injection ANDA to a global pharmaceutical company. The company retains ownership of its broader ketamine portfolio, including programs for Parkinson's disease, ALS, and complex regional pain syndrome (CRPS).
The strategic sale provides potential non-dilutive capital tied to U.S. commercial sales and leverages the buyer's established infrastructure for sterile injectables. PharmaTher's next six-month strategy includes pursuing international partnerships, engaging with the FDA for CRPS and Parkinson's disease programs, and exploring pharmaceutical partnerships for its ketamine microneedle patch and wearable pump programs.
PharmaTher Holdings (OTCQB: PHRRF) ha annunciato aggiornamenti strategici dopo la vendita della sua Ketamine Hydrochloride Injection ANDA a una società farmaceutica globale. L'azienda mantiene la proprietà del suo portafoglio più ampio di ketamina, inclusi programmi per malattia di Parkinson, SLA e complesso dolore regionale cronico (CRPS).
La vendita strategica fornisce potenziale capitale non diluitivo legato alle vendite commerciali statunitensi e sfrutta l'infrastruttura consolidata dell'acquirente per gli injectables sterili. La strategia dei prossimi sei mesi di PharmaTher include perseguire partnership internazionali, interfacciarsi con la FDA per i programmi CRPS e Parkinson e esplorare partnership farmaceutiche per il suo patch di ketamina a microneedle e i programmi di pompe indossabili.
PharmaTher Holdings (OTCQB: PHRRF) ha anunciado actualizaciones estratégicas tras la venta de su ANDA de inyección de clorhidrato de ketamina a una compañía farmacéutica global. La empresa conserva la propiedad de su porfolio más amplio de ketamina, incluidos programas para la enfermedad de Parkinson, ELA y el síndrome de dolor regional complejo (CRPS).
La venta estratégica proporciona potencial capital no dilutivo vinculado a las ventas comerciales en EE. UU. y aprovecha la infraestructura ya establecida del comprador para inyectables estériles. La estrategia de PharmaTher para los próximos seis meses incluye buscar asociaciones internacionales, comunicarse con la FDA para los programas de CRPS y Parkinson, y explorar asociaciones farmacéuticas para su parche de ketamina con microneedle y sus programas de bombas portátiles.
PharmaTher Holdings (OTCQB: PHRRF)가 글로벌 제약사에 Ketamine Hydrochloride Injection ANDA를 매각한 후 전략 업데이트를 발표했습니다. 회사는 파킨슨병, ALS 및 복합부위통증증후군(CRPS)을 포함한 보다 광범위한 케타민 포트폴리오에 대한 소유권을 유지합니다.
전략적 매각은 미국 상업 매출과 연계된 비희석형 자본의 가능성을 제공하고, 매수자의 무균 주사제 인프라를 활용합니다. PharmaTher의 향후 6개월 전략은 국제 파트너십 탐색, CRPS와 파킨슨병 프로그램에 대한 FDA와의 협의, 그리고 케타민 마이크로니들 패치 및 웨어러블 펌프 프로그램을 위한 제휴를 모색하는 것을 포함합니다.
PharmaTher Holdings (OTCQB: PHRRF) a annoncé des mises à jour stratégiques suite à la vente de son ANDA d'injection d'hydrochlorure de kétamine à une société pharmaceutique mondiale. L'entreprise conserve la propriété de son portefeuille plus large de kétamine, notamment des programmes pour la maladie de Parkinson, la SLA et le syndrome douloureux régional complexe (CRPS).
La vente stratégique offre un capital potentiellement non dilutif lié aux ventes commerciales américaines et exploite l'infrastructure du acquéreur pour les injectables stériles. La stratégie des six prochains mois de PharmaTher comprend la poursuite de partenariats internationaux, des échanges avec la FDA pour les programmes CRPS et Parkinson et l'exploration de partenariats pharmaceutiques pour son patch microneedle à la kétamine et ses programmes de pompe portable.
PharmaTher Holdings (OTCQB: PHRRF) hat strategische Aktualisierungen angekündigt, nachdem der Ketamine-Hydrochlorid-Injection ANDA an ein globales Pharmaunternehmen verkauft wurde. Das Unternehmen behält das Eigentum an seinem breiteren Ketamin-Portfolio, einschließlich Programme für Parkinson-Krankheit, ALS und CRPS (komplexes regionales Schmerzsyndrom).
Der strategische Verkauf bietet potenziell nicht verwässerndes Kapital, das an US-Vertriebsumsätze gebunden ist, und nutzt die etablierte Infrastruktur des Käufers für sterile Injektionspräparate. Die nächste sechsmonatige Strategie von PharmaTher umfasst internationale Partnerschaften zu verfolgen, sich mit der FDA für CRPS- und Parkinson-Programme abzustimmen und pharmazeutische Partnerschaften für seinen Ketamin-Microneedle-Patch und Wearable-Pump-Programme zu prüfen.
PharmaTher Holdings (OTCQB: PHRRF) قد أعلنت عن تحديثات استراتيجية عقب بيع موافقتها على Ketamine Hydrochloride Injection ANDA لشركة أدوية عالمية. تحتفظ الشركة بملكيتها لمحفظة الكيتامين الأوسع، بما في ذلك البرامج الخاصة بمرض باركنسون وALS ومتلازمة الألم الإقليمي المعقدة (CRPS).
يوفر البيع الاستراتيجي رأس مال غير مخفّض محتمل مرتبط بمبيعات الولايات المتحدة التجارية ويستفيد من البنية التحتية للمشتري في المنتجات المحقونة المعقمة. تتضمن استراتيجية PharmaTher خلال الأشهر الستة المقبلة السعي إلى شراكات دولية، والتواصل مع FDA بشأن برامج CRPS ومرض باركنسون، واستكشاف شراكات صيدلانية للاصقة Ketamine microneedle وبرامج المضخات القابلة للارتداء.
PharmaTher Holdings (OTCQB: PHRRF) 已宣布在将其氯胺盐注射剂的 ANDA 出售给全球制药公司后所作的战略更新。公司保留其更广泛的氯胺产品组合的所有权，包括用于<帕金森病、ALS 与复杂性区域性疼痛综合征（CRPS）的项目。
这项战略性出售为与美国商业销售相关的潜在非摊薄资金提供了机会，并利用买方在无菌注射剂方面已建立的基础设施。PharmaTher 未来六个月的策略包括 寻求国际合作伙伴关系、与 FDA 就 CRPS 与帕金森病项目进行沟通，以及为其氯胺微针贴片和可穿戴泵项目探索制药合作伙伴关系。
- Strategic sale of Ketamine ANDA provides non-dilutive capital from U.S. commercial sales
- Retained ownership of valuable ketamine portfolio for Parkinson's, ALS, and CRPS
- Validated CMC package from ANDA development can be leveraged for future NDAs
- Partnership with established pharmaceutical company enhances market penetration potential
- Company lacks infrastructure for independent generic ketamine injectable commercialization
- Specific terms of the pharmaceutical partnership remain confidential
- Phase 3 study design for Parkinson's disease still requires FDA agreement
TORONTO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to provide a corporate update following its recently announced sale of the Company’s Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP (the “Ketamine ANDA”). The transaction was a strategic sale of a single generic ketamine asset and the sale did not include PharmaTher’s broader ketamine portfolio. The Company continues to own its ketamine-based programs, including for Parkinson’s disease, amyotrophic lateral sclerosis (ALS), complex regional pain syndrome (CRPS), as well as its ketamine microneedle patch and wearable pump programs for mental health, neurological, and pain disorders.
Building Value Beyond the Ketamine ANDA
The sale of the Ketamine ANDA was a strategic decision that provides PharmaTher with potential non-dilutive capital tied to U.S. commercial sales only. Successfully launching and scaling a generic ketamine injectable on its own would require significant capital, inventory commitments, sales infrastructure, and specialized expertise. By partnering with a well-established global pharmaceutical company specializing in sterile injectables and complex generics, as well as having a growing U.S. commercial division, the Ketamine ANDA would have a better chance of achieving its commercial potential. The pharmaceutical partner has the manufacturing scale, regulatory track record, and commercial infrastructure to compete directly with existing generic ketamine competitors in the U.S. market.
Importantly, the investment made in developing the Ketamine ANDA was also intended to support and strengthen PharmaTher’s broader ketamine strategy, advancing its other proprietary ketamine-based programs. The work completed to secure the Ketamine ANDA also provides a validated CMC (Chemistry, Manufacturing and Controls) package that would be leveraged for future New Drug Applications (NDAs) via the 505(b)(2) regulatory pathway, potentially saving substantial time and development costs since the foundational work has already been reviewed by the FDA.
The Ketamine ANDA sale does not limit PharmaTher’s ability to research, develop, manufacture, and commercialize any strengths, dosage forms, or formulations of ketamine for any indications in any territories worldwide, including the U.S., provided that the Company does not, directly or indirectly, develop, file, or seek regulatory approval for the exact same product approved under the Ketamine ANDA, which the Company would not seek since future ketamine products will be differentiated and non-generic. The pharmaceutical partner has requested that specific terms remain confidential at this time for competitive and regulatory reasons.
Next Steps
Over the next six months, PharmaTher is concentrating on several key initiatives aimed at realizing the commercial potential of its ketamine portfolio.
- International Partnerships: The Company is actively pursuing new global partnerships that could provide additional non-dilutive funding and accelerate the development and commercialization of its ketamine-based products.
- Regulatory Engagements: PharmaTher is planning meetings with the U.S. FDA to define an expedited clinical and regulatory path for ketamine in CRPS and to seek agreement on a Phase 3 study design for Parkinson’s disease.
- Pharma Opportunities: Both the CRPS and Parkinson’s programs, if supported by positive FDA guidance and outcomes, would be positioned as attractive candidates for potential partnerships with larger pharmaceutical companies, as well as for the Company’s ketamine microneedle patch and wearable pump programs.
Fabio Chianelli, CEO of PharmaTher, stated:
“Our investment in developing the Ketamine ANDA was a strategic move, designed not only for near-term monetization but also to establish a long-term foundation for our proprietary ketamine pipeline. The sale of the Ketamine ANDA allows us to capitalize on the generic injectable ketamine market while simultaneously advancing our proprietary ketamine-based programs into larger market opportunities. We've partnered with a pharmaceutical company that possesses the necessary scale and infrastructure to effectively compete with existing generic ketamine competitors in the U.S. market. Concurrently, we are pursuing international partnerships to fully realize the global potential of our ketamine portfolio.”
About PharmaTher
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on unlocking the pharmaceutical potential of ketamine for mental health, pain, and neurological disorders. For more information, visit PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary and Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding potential milestone and profit-sharing payments, the commercial success of the ANDA, and the Company’s ability to advance next-generation ketamine programs. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, among others, the commercial performance of the ANDA product, regulatory approvals, market acceptance, competition, and the Buyer’s and Company’s ability to execute its business strategy. Readers are cautioned not to place undue reliance on forward-looking statements. PharmaTher disclaims any obligation to update or revise forward-looking statements except as required by law. In addition, this press release contains cautionary and forward looking statements and information within the meaning of applicable Canadian securities legislation. These relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", “eligible”, “ensure”, “enable”, "believe", "will", "projected", "estimated", "potential", “promise”, “strong”, "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, “position”, “leverage”, “mitigate”, “makes”, “before”, “prior”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the year ended May 31, 2025 dated September 26, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
FAQ
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