PharmaTher Announces Sale of Ketamine ANDA with Potential to Generate Over US$25 Million in Milestone and Profit-Sharing Payments
PharmaTher Holdings (OTCQB:PHRRF) has entered into a definitive Asset Purchase Agreement to sell its Ketamine Hydrochloride Injection USP ANDA to a global pharmaceutical company specializing in sterile injectables. The transaction includes an upfront cash payment and potential milestone payments that could exceed US$25 million in total consideration.
The deal structure includes profit-sharing arrangements for seven years following the first commercial sale. The undisclosed buyer is an FDA-approved manufacturer with over 40 approved ANDAs in the U.S. This strategic move allows PharmaTher to maintain exposure to the ketamine market while focusing on developing next-generation ketamine programs, including long-acting injectables and novel delivery methods.
PharmaTher Holdings (OTCQB:PHRRF) ha stipulato un Accordo definitivo di Acquisto di Attività per vendere la sua Ketamine Hydrochloride Injection USP ANDA a una azienda farmaceutica globale specializzata in iniettabili sterili. L'operazione prevede un pagamento iniziale in contanti e potenziali pagamenti legati a traguardi che potrebbero superare US$25 milioni di valore complessivo.
La struttura dell'accordo prevede accordi di condivisione dei profitti per sette anni a partire dalla prima vendita commerciale. L'acquirente non rivelato è un produttore approvato dalla FDA con oltre 40 ANDA approvate negli Stati Uniti. Questa mossa strategica consente a PharmaTher di mantenere l'esposizione al mercato della ketamina pur concentrandosi sullo sviluppo di programmi di ketamina di nuova generazione, inclusi iniettabili a lunga durata e nuovi metodi di somministrazione.
PharmaTher Holdings (OTCQB:PHRRF) ha suscrito un Acuerdo Definitivo de Compra de Activos para vender su Ketamine Hydrochloride Injection USP ANDA a una empresa farmacéutica global especializada en inyectables estériles. La transacción incluye un pago inicial en efectivo y posibles pagos por hitos que podrían superar US$25 millones en compensación total.
La estructura del trato contempla acuerdos de participación en los beneficios durante siete años tras la primera venta comercial. El comprador no divulgado es un fabricante aprobado por la FDA con más de 40 ANDA aprobadas en Estados Unidos. Este movimiento estratégico permite a PharmaTher mantener exposición al mercado de ketamina mientras se centra en desarrollar programas de ketamina de nueva generación, incluyendo inyectables de acción prolongada y nuevos métodos de administración.
PharmaTher Holdings (OTCQB:PHRRF) 는 멸균 주사제 분야를 전문으로 하는 글로벌 제약회사에 킷민하이드로클로라이드 주사제 USP ANDA를 매각하기로 하는 확정 자산매매계약을 체결했습니다. 거래에는 초기 현금 지급과 잠재적 마일스톤 지급이 포함되며, 총 보상은 US$25 백만 달러 이상일 수 있습니다.
거래 구조에는 최초 상업 판매 이후 7년간의 이익 공유 체계가 포함됩니다. 비공개 매수자는 FDA 승인 제조업체로 미국에서 40개 이상의 승인된 ANDA를 보유하고 있습니다. 이 전략적 조치는 PharmaTher가 케타민 시장에 대한 노출을 유지하면서 차세대 케타민 프로그램, 장기 작용 주사제 및 새로운 전달 방법 개발에 집중할 수 있게 해줍니다.
PharmaTher Holdings (OTCQB:PHRRF) a conclu un accord définitif d’achat d’actifs pour vendre son Ketamine Hydrochloride Injection USP ANDA à une société pharmaceutique mondiale spécialisée dans les injectables stériles. La transaction comprend un paiement initial en espèces et des paiements potentiels liés à des jalons qui pourraient dépasser US$25 millions de contrepartie totale.
La structure de l’accord prévoit des accords de partage des bénéfices pour sept ans après la première vente commerciale. L’acheteur non divulgué est un fabricant approuvé par la FDA avec plus de 40 ANDA approuvées aux États‑Unis. Cette démarche stratégique permet à PharmaTher de rester exposé au marché de la kétamine tout en se concentrant sur le développement de programmes de nouvelle génération, y compris des injectables à action prolongée et de nouvelles méthodes d’administration.
PharmaTher Holdings (OTCQB:PHRRF) hat eine endgültige Asset Purchase Agreement unterzeichnet, um seine Ketamine Hydrochloride Injection USP ANDA an ein globales Pharmaunternehmen zu verkaufen, das sich auf sterile Injektionsmittel spezialisiert hat. Die Transaktion umfasst eine sofortige Bargeldzahlung und potenzielle Meilensteinzahlungen, die US$25 Millionen an Gesamtsumme übersteigen könnten.
Die Deal-Struktur sieht Gewinnbeteiligungsvereinbarungen für sieben Jahre nach dem ersten kommerziellen Verkaufszeitpunkt vor. Der undisclosed Käufer ist ein FDA-angepasster Hersteller mit über 40 genehmigten ANDAs in den USA. Diese strategische Bewegung ermöglicht PharmaTher, seine Exposition gegenüber dem Ketaminmarkt zu behalten, während es sich auf die Entwicklung von Ketamin-Nachfolgeprogrammen konzentriert, einschließlich lang wirkender Injektionsmittel und neuartiger Verabreichungsmethoden.
PharmaTher Holdings (OTCQB:PHRRF) أبرمت اتفاقية أساسية لشراء أصول لبيع Ketamine Hydrochloride Injection USP ANDA إلى شركة أدوية عالمية متخصصة في الحقن المعقمة. تشمل الصفقة دفعة نقدية مقدمة وإمكانات دفعات لقاء أهداف قد تتجاوز US$25 مليون كإجمالي الاعتبار.
تعتمد هيكلة الصفقة على اتفاقيات تقاسم الأرباح لمدة سبع سنوات بعد أول بيع تجاري. المشتري غير المُعلن عنه هو مصنع معتمد من FDA ويملك أكثر من 40 ANDA معتمدة في الولايات المتحدة. هذه الخطوة الاستراتيجية تتيح لـ PharmaTher الحفاظ على تعرضه لسوق الكيتامين بينما يركز على تطوير برامج كيتامين من الجيل التالي، بما في ذلك الحقن طويلة المفعول وطرق التوصيل الجديدة.
PharmaTher Holdings (OTCQB:PHRRF) 已签署一项资产购买协议，拟将其 Ketamine Hydrochloride Injection USP ANDA 出售给一家专注于无菌注射剂的全球制药公司。交易包括一笔前期现金支付以及可能的里程碑付款，总对价可能超过US$25 million。
交易结构包括在首次商业销售后七年内的利润分享安排。该买家为未披露的FDA批准制造商，在美国拥有超过40个已批准的ANDAs。此举使 PharmaTher 能继续参与氯胺市场，同时专注于开发下一代氯胺项目，包括长效注射剂和新型给药方式。
- Potential to generate over US$25 million in milestone and profit-sharing payments
- Seven-year profit-sharing agreement following first commercial sale
- Partnership with established FDA-approved manufacturer having 40+ approved ANDAs
- Allows company to focus on developing next-generation ketamine programs
- Maintains exposure to growing ketamine market while monetizing current assets
- Actual milestone payments are contingent on product performance with no guarantees
- Upfront payment amount remains confidential
- Deal closing subject to regulatory approvals and conditions
TORONTO, Oct. 01, 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 announce that it has entered into a definitive Asset Purchase Agreement (the “Agreement”) for the sale of its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a well-established global pharmaceutical company specializing in sterile injectables and complex generics (the “Buyer”).
“This transaction validates the significant value embedded in our ketamine assets,” said Fabio Chianelli, Chief Executive Officer of PharmaTher. “We are excited to announce this agreement with a leading global sterile-injectables company, structured to allow PharmaTher to share in the upside of future sales of the growing ketamine market. Importantly, it also enables us to leverage the foundation we built with our ketamine program to advance our proprietary next-generation therapies, which we believe represent multiple high-value opportunities for both patients and shareholders.”
Transaction Terms
Under the terms of the Agreement, PharmaTher will receive a confidential upfront cash payment at closing and is eligible for milestone payments based on cumulative sales thresholds, along with ongoing profit-sharing for a period of seven years following the first commercial sale. In total, the Agreement contemplates potential consideration of more than US
The Buyer has requested confidentiality at this time for strategic business reasons, including competitive positioning in the U.S. ketamine and sterile injectable generics market. Investors should note that the Buyer is a credible, FDA-approved sterile-injectables manufacturer with an established track record of securing multiple ANDA approvals. Through its rapidly growing U.S. subsidiary, the Buyer is actively commercializing a portfolio of more than 40 approved ANDAs across the U.S., in addition to global operations. Its demonstrated expertise in developing, manufacturing, and commercializing of injectable medicines makes it a strong partner to unlock the commercial potential of ketamine in the U.S.
The Agreement enables PharmaTher to participate in the potential long-term commercial success of the ANDA while maintaining meaningful exposure to the global ketamine market. It also allows the Company to focus on advancing next-generation ketamine programs, including long-acting injectables and novel delivery methods for potential psychiatric, pain, neurological, and orphan drug indications.
The Agreement is subject to customary closing conditions, including required regulatory notifications, with the effective date of closing expected to occur in the near term.
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.
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