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$0.75-$2.2B and continues active partner discussions to support registrational development and commercialization.
“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.
