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

Executive Summary

• The U.S. FDA announced ketamine as a recipient of its new Commissioner's National Priority Voucher (CNPV) pilot, positioning the drug as a national‑priority anesthesia medicine.
• PharmaTher’s previously disclosed ANDA sale for generic ketamine includes potential payment milestones of up to US $25 million plus an uncapped multi‑year profit‑sharing component, providing significant upside without additional capital outlay.
• The CNPV designation is expected to create a durable U.S. demand tailwind and accelerate PharmaTher’s capital‑light 505(b)(2) strategy for novel ketamine indications (e.g., Parkinson’s LID‑PD, ALS, CRPS).

Key Details

• FDA CNPV Pilot: Ketamine named among the first recipients of the Commissioner's National Priority Voucher program on Oct 16 2025, signaling a national priority for domestic manufacturing of this critical anesthesia drug.
• AND​A Sale Structure:
• Purchaser: sterile‑injectables partner with U.S. manufacturing and regulatory capabilities.
• Payment terms: up to US $25 million in milestones; additional upside via an uncapped, multi‑year profit‑sharing arrangement tied to generic ketamine sales in the U.S.
• Capital Light Execution: The ANDA transaction reduces PharmaTher’s execution risk and capital requirements—no need for new plant construction, inventory holding, or a dedicated national sales force.
• Retention of Rights: PharmaTher retains all rights to non‑generic ketamine applications, including novel formulations, delivery technologies, and 505(b)(2) programs targeting Parkinson’s disease (LID‑PD), ALS, CRPS, and its proprietary brand KETARx™.
• Regulatory Mechanics: CNPV offers a ~1–2 month decision window for complete submissions, aligning with PharmaTher’s strategy to file FDA‑aligned CMC packages and focused clinical “bridge” studies under the 505(b)(2) pathway.
• Real‑World Evidence (RWE): FDA’s growing acceptance of fit‑for‑purpose RWE supports PharmaTher’s use of high‑quality real‑world data to de‑risk timelines and costs for new indications.
• Digital Health AI Synergy: The ketamine market tailwind is expected to boost activity for PharmaTher’s Digital Health AI assets—KetaVault™ (ketamine data repository) and KetAImine™ (indication discovery platform).
• Pipeline Highlight – LID‑PD: Preparing a Pre‑Phase 3 (Type B) FDA package for levodopa‑induced dyskinesia in Parkinson’s disease, with an estimated U.S. market opportunity of US $0.75–2.2 billion and ongoing partner discussions.
• CEO Quote: “The ANDA sale reduces execution risk and capital burden while preserving substantial, non‑dilutive upside… the FDA’s CNPV selection de‑risks our opportunity and positions us to convert these tailwinds into durable value.” – Fabio Chianelli, Founder & CEO

Notable Quotes

• “With the FDA's CNPV spotlight for ketamine, our focus continues on the bigger picture and the path ahead,” — Fabio Chianelli, Founder & CEO, PharmaTher.

Materiality: Material – Positive (the regulatory designation and ANDA transaction together provide a significant upside catalyst for the company).