PharmaTher Announces Sale of Ketamine ANDA with Potential to Generate Over US$25 Million in Milestone and Profit-Sharing Payments

Executive Summary

• PharmaTher entered into a definitive Asset Purchase Agreement to sell its ANDA for Ketamine Hydrochloride Injection USP to a global sterile‑injectables manufacturer.
• The transaction provides an upfront cash payment (amount confidential) and potential milestone and profit‑sharing payments that could total more than US $25 million over seven years.
• Proceeds will enable PharmaTher to focus on advancing next‑generation ketamine therapies, including long‑acting injectables and novel delivery methods for psychiatric, pain, neurological, and orphan indications.

Key Details

• Agreement Parties: PharmaTher Holdings Ltd. (seller) and an undisclosed global pharmaceutical company specializing in sterile injectables and complex generics (buyer).
• Asset Sold: Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP.
• Consideration Structure:
• Confidential upfront cash payment at closing.
• Milestone payments tied to cumulative sales thresholds.
• Ongoing profit‑sharing on net sales for a period of seven years after the first commercial sale.
• Total potential consideration > US $25 million, subject to achievement of performance milestones.
• Strategic Rationale:
• Allows PharmaTher to monetize its ketamine ANDA while retaining upside participation in future sales.
• Frees capital and management focus to advance proprietary next‑generation ketamine programs (long‑acting injectables, novel delivery methods).
• Buyer Profile: FDA‑approved sterile‑injectables manufacturer with a portfolio of >40 approved ANDAs in the U.S., strong commercial capabilities for injectable medicines.
• Closing Conditions: Standard regulatory notifications and customary closing conditions; expected to close in the near term.

Notable Quotes

“This transaction validates the significant value embedded in our ketamine assets… 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.” – Fabio Chianelli, CEO, PharmaTher Holdings Ltd.