PharmaTher Applauds FDA's Commissioner's National Priority Voucher (CNPV) Selection of Ketamine; Company Highlights Potential Ketamine Opportunity, 505(b)(2) Focus, and Upside from Strategic ANDA Sale
PharmaTher (OTCQB: PHRRF) applauds the FDA's October 16, 2025 selection of ketamine under the Commissioner's National Priority Voucher (CNPV) pilot and says this elevates on‑shore ketamine as a national priority. PharmaTher highlights a reduced regulatory decision window (~1–2 months for complete files), resolution of prior U.S. shortages (Feb 2018–Aug 2025), and potential demand tailwinds for domestic suppliers.
The company cites its previously announced ANDA sale with up to US$25 million in potential payment milestones plus multi‑year profit sharing, retention of non‑generic ketamine rights (505(b)(2) programs including LID‑PD), and a reported U.S. market opportunity of ~US$0.75–$2.2B for LID‑Parkinson's.
PharmaTher (OTCQB: PHRRF) applaude la decisione della FDA del 16 ottobre 2025 di selezionare la ketamina nell'ambito del programma pilota del National Priority Voucher (CNPV) del Commissario e afferma che questo eleva la ketamina domestica a una priorità nazionale. PharmaTher evidenzia una riduzione della finestra decisionale regolatoria (~1–2 mesi per i fascicoli completi), la risoluzione delle precedenti carenze negli Stati Uniti (febbraio 2018–agosto 2025) e potenziali spinte di domanda a favore dei fornitori nazionali.
La società cita la sua vendita ANDA precedentemente annunciata con fino a US$25 milioni in potenziali milestone di pagamento oltre a una condivisione di profitti pluriennale, la conservazione dei diritti non generici sulla ketamina (programmi 505(b)(2) inclusi LID‑PD) e una opportunità di mercato statunitense riportata per LID‑Parkinson's di ~US$0,75–$2,2 miliardi.
PharmaTher (OTCQB: PHRRF) aplaude la selección de la FDA del 16 de octubre de 2025 de la ketamina dentro del piloto de vouchers de prioridad nacional (CNPV) del Comisionado y afirma que esto eleva la ketamina nacional a una prioridad. PharmaTher destaca una ventana de decisión regulatoria reducida (~1–2 meses para expedientes completos), la resolución de las escaseces anteriores en EE. UU. (febrero 2018–agosto 2025) y posibles vientos de demanda para proveedores domésticos.
La compañía cita su venta de ANDA anunciada previamente con hasta US$25 millones en posibles hitos de pago más una participación en pérdidas y ganancias a varios años, la retención de derechos no genéricos de ketamina (programas 505(b)(2) que incluyen LID‑PD) y una oportunidad de mercado en EE. UU. reportada de ~US$0.75–$2.2B para LID‑Parkinson.
PharmaTher (OTCQB: PHRRF)은 2025년 10월 16일 FDA가 케타민을 커미셔너의 국가 우선권 바우처(CNPV) 파일럿에 선정한 것을 환영하며 이것이 국내 케타민을 국가적 우선순위로 올린다고 말합니다. PharmaTher는 전체 파일에 대한 규제 의사결정 창이 단축되는 것(~ 1–2개월)과 미국의 기존 공급 부족 해결(Feb 2018–Aug 2025) 및 국내 공급 업체에 대한 잠재적 수요 증가를 강조합니다.
또한 회사는 이전에 발표한 ANDA 매각과 최대 US$25백만의 잠재적 지급 마일스톤 및 다년간의 이익 공유, 비-제네릭 케타민 권리의 보유(505(b)(2) 프로그램 포함 LID‑PD), LID‑Parkinson에 대한 미국 시장 기회가 ~US$0.75–$2.2B라고 보고된 점을 인용합니다.
PharmaTher (OTCQB: PHRRF) salue la sélection par la FDA du 16 octobre 2025 de la kétamine dans le cadre du pilote National Priority Voucher (CNPV) du Commissaire et affirme que cela élève la kétamine nationale au rang de priorité. PharmaTher met en avant une réduction du délai de décision réglementaire (~1–2 mois pour les dossiers complets), la résolution des pénuries antérieures aux États‑Unis (février 2018–août 2025) et des vents de demande potentiels pour les fournisseurs nationaux.
La société cite sa vente ANDA annoncée précédemment avec jusqu'à US$25 millions en jalons de paiement potentiels plus un partage des profits sur plusieurs années, la rétention des droits non génériques sur la kétamine (programmes 505(b)(2) incluant LID‑PD) et une opportunité de marché américaine signalée pour LID‑Parkinson à environ ~US$0,75–2,2 milliards.
PharmaTher (OTCQB: PHRRF) lobt die FDA‑Auswahl vom 16. Oktober 2025 von Ketamin im Rahmen des nationalen Priority Voucher Pilotprogramms des Kommissars (CNPV) und sagt, dass dies Ketamin in den USA zu einer nationalen Priorität erhebt. PharmaTher hebt ein reduziertes regulatorisches Entscheidungsfenster hervor (~1–2 Monate für vollständige Unterlagen), die Beilegung früherer Versorgungsengpässe in den USA (Februar 2018–August 2025) sowie potenzielle Nachfrageschwänke für inländische Lieferanten hervor.
Das Unternehmen verweist auf seine zuvor angekündigte ANDA-Verkauf mit bis zu US$25 Millionen an potenziellen Zahlungsmeilensteinen plus mehrjährige Gewinnbeteiligung, Erhalt der nicht‑generischen Ketaminrechte (505(b)(2) Programme einschließlich LID‑PD) und eine gemeldete US‑Marktchance von ~US$0,75–2,2 Mrd. für LID‑Parkinson.
PharmaTher (OTCQB: PHRRF) يثني على اختيار FDA في 16 أكتوبر 2025 لـ الكيتامين ضمن تجربة برنامج القسيمة الوطنية الأولوية (CNPV) للمفوّض، ويقول إن ذلك يرفع الكيتامين المحلي إلى أولوية وطنية. تؤكد PharmaTher على تقليل نافذة القرار التنظيمي (~1–2 أشهر للملفات الكاملة)، وحل النقص السابق في الولايات المتحدة (فبراير 2018–أغسطس 2025)، وفرص طلب محتملة للموردين المحليين.
وتستشهد الشركة بإعلانها السابق عن صفقة ANDA مع حتى US$25 مليون كخطوات دفع محتملة بالإضافة إلى تقاسم الأرباح على مدى سنوات، واحتفاظها بحقوق الكيتامين غير الجنيريكية (برامج 505(b)(2) بما في ذلك LID‑PD)، وفرصة سوق أمريكية لـ LID‑Parkinson تبلغ نحو ~US$0.75–$2.2 مليار.
PharmaTher (OTCQB: PHRRF) 称赞 FDA 于 2025 年 10 月 16 日 在 委员会 的 国家优先券试点 (CNPV) 下 选择 氯胺酮，并表示这将本土氯胺酮提升为国家级优先事项。PharmaTher 强调监管决策窗口缩短（大约 1–2 个月，适用于完整档案）、解决此前美国的短缺（2018 年 2 月–2025 年 8 月）以及对国内供应商的潜在需求增长。
公司还引用其早前宣布的 ANDA 出售，最高可能达到 US$25 百万 的支付里程碑以及多年的利润分享、保留非仿制氯胺酮的权利（包括 LID‑PD 的 505(b)(2) 项目），并报道了 LID‑Parkinson 的美国市场机会约为 ~US$0.75–$2.2B。
- Potential payment milestones of up to US$25 million from ANDA sale
- ANDA sale includes multi‑year profit sharing enabling upside without capital plant spend
- CNPV offers ~1–2 month decision window for complete filings
- Company reports U.S. LID‑PD market ~US$0.75–$2.2B
- U.S. generic ketamine economics depend on purchaser meeting milestone triggers (payments tied to achievement)
- PharmaTher relies on partner for U.S. sterile‑injectable manufacturing, regulatory, and commercial execution
Toronto, Ontario--(Newsfile Corp. - October 17, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today applauds the U.S. Food and Drug Administration's ("FDA") announcement on October 16, 2025 of the first-ever recipients of the new Commissioner's National Priority Voucher ("CNPV") pilot program, which include "ketamine for domestic manufacturing of a critical drug for general anesthesia." The pilot elevates ketamine as a national priority.
The CNPV is expected to a catalyst for the ketamine market—and PharmaTher is positioned at the forefront. By prioritizing ketamine, the FDA is signaling to hospitals, GPOs, and public buyers that on-shore, quality-assured supply is a national objective, potentially amplifying demand for reliable U.S. sources. At the same time, the program's team-based review and ~1-2 month decision window reduce regulatory friction for aligned, complete filings, enabling faster conversion of supply into sales. Finally, ecosystem signals—public announcements referencing ketamine API under CNPV and the resolution of multi-year U.S. shortages (February 2018 to August 2025)—point to sustained momentum for ketamine.
Strategic Highlights — What This Means for PharmaTher
- CNPV fuels PharmaTher's Momentum. FDA's naming of ketamine as a national-priority anesthesia medicine creates a durable U.S. demand tailwind precisely where PharmaTher can participate economically via its previously announced ANDA sale.
- Economic participation without heavy spend. The Company's sterile-injectables partner (the purchaser of the ANDA) brings experienced manufacturing and U.S. regulatory/commercial capabilities. The transaction provides potential payment milestones of up to US
$25 million and is not limited to US$25 million due to a multi-year profit-sharing component—enabling upside participation without building plants, carrying inventory, or funding a national sales force. - Reinforcing PharmaTher's Opportunity. The previously announced ketamine ANDA sale reduces PharmaTher's execution risk and capital requirements, while preserving significant long-term upside linked to potential U.S. ketamine growth. Importantly, the ANDA sale applies only to generic ketamine sales in the U.S.; PharmaTher retains all rights to non-generic applications of ketamine—including new indications, novel formulations and delivery technologies, and its 505(b)(2) programs, which include Parkinson's disease (LID-PD), ALS, CRPS, and the Company's proposed brand, KETARx™.
- From supply tailwind to pipeline compounding. The same policy focus that lifts ketamine supply also reinforces the Company's capital-light 505(b)(2) strategy—creating a pathway to additional potential NDAs that can compound value beyond the ANDA economics.
How CNPV potentially accelerates PharmaTher's capital-light ketamine-based 505(b)(2) strategy
- Regulatory mechanics favor completeness and speed. CNPV encourages robust CMC pre-submission and a senior, multidisciplinary review that can deliver ~1-2 month decisions once the file is complete—aligning with the Company's approach to submit its FDA-aligned CMC, while executing focused clinical "bridges" suitable for 505(b)(2).
- CMC leverage from PharmaTher's ketamine experience. The Company's FDA-aligned ketamine CMC know-how (validated methods, specifications, stability programs) from its recent ANDA approval now supports future 505(b)(2) filings.
- RWE acceptance strengthens PharmaTher's model. FDA's growing framework for fit-for-purpose Real-World Evidence supports using high-quality RWD/RWE to complement efficient clinical packages for already-approved drugs seeking new indications—further de-risking timelines and cost.
- CNPV recognition of ketamine signals a constructive FDA outlook for the category. PharmaTher intends to evaluate potential future CNPV nominations and, where appropriate, pursue other expedited programs (e.g., Fast Track, Breakthrough Therapy) for differentiated ketamine assets.
Partner momentum: a stronger case to commercialize novel ketamine products
CNPV's explicit focus on domestic, reliable ketamine supply strengthens the rationale for pharmaceutical partners to engage in the development and commercialization of novel ketamine products for new indications. Consistent with its October 2, 2025 corporate update, PharmaTher continues active discussions and is positioned first in line to collaborate with U.S.-focused manufacturers and commercial organizations seeking differentiated ketamine programs under the 505(b)(2) pathway.
PharmaTher's Digital Health AI for ketamine tailwind
With ketamine now elevated under CNPV, PharmaTher expects increased data and partnering activity to unlock its ketamine-based pipeline and act as a potential growth driver for its Digital Health AI division, which comprises KetaVault™ (the Company's proprietary ketamine data repository) and the KetAImine™ platform for indication discovery, prioritization, and regulator-aligned program design.
LID-Parkinson's: Phase 3-Ready package under 505(b)(2)
PharmaTher is preparing a Pre-Phase 3 (Type B) FDA package to align on a single, well-controlled registrational trial for LID-PD, consistent with prior Agency feedback. The Company has communicated a U.S. market opportunity of ~US
"With the FDA's CNPV spotlight for ketamine, our focus continues on the bigger picture and the path ahead," said Fabio Chianelli, Founder & CEO of PharmaTher. "By design, the ANDA sale reduces execution risk and capital burden while preserving substantial, non-dilutive upside through sales milestones and uncapped profit sharing. Coupled with the FDA's CNPV selection for ketamine and the FDA's expanding guidance around RWE, we see a larger, de-risked opportunity in front of PharmaTher. Our capital-light 505(b)(2) approach—grounded in FDA-aligned ketamine CMC know-how—positions us to convert these tailwinds into durable value and pharma partnerships."
For additional information visit www.pharmather.com and download PharmaTher's latest corporate presentation (here).
Note: PharmaTher is not asserting that it—or any partner—is a CNPV recipient. The Company is commenting on the program's explicit inclusion of ketamine, the potential implications for the U.S. market, and for PharmaTher.
About PharmaTher
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine. 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
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that the Company will proceed with the clinical development and that the FDA will support any potential request for an expedited path to approval. These risks include, among others, the commercial performance of the ANDA product, FDA acceptance of the regulatory plan, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company programs being partnered. 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 "aim", "anticipate", "before", "believe", "closer", "confident", "could", "eligible", "enable", "ensure", "estimated", "expect", "intend", "lead", "leverage", "makes", "may", "mitigate", "plan", "position", "potential", "prior", "promise", "projected", "proposed", "provide", "purpose", "ready", "significant", "strong", "toward", "will", "would", 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 the 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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FAQ
What did PharmaTher announce after the FDA named ketamine to the CNPV on October 16, 2025 (PHRRF)?
How does the PharmaTher ANDA sale affect PHRRF shareholders and revenue potential?
Does PharmaTher keep rights to non‑generic ketamine programs after the ANDA sale (PHRRF)?
What near‑term regulatory advantage does CNPV offer PHRRF's ketamine programs?
What commercial opportunity did PharmaTher cite for LID‑Parkinson's in its update (PHRRF)?
