Pharmather signs definitive deal to sell ketamine ANDA

Executive Summary

• Pharmather Holdings entered into a definitive asset purchase agreement to sell its ketamine hydrochloride injection ANDA (No. 217858) to a global sterile‑injectables manufacturer.
• The transaction includes an undisclosed upfront cash payment and provides for milestone payments and profit‑sharing over seven years, with total potential consideration exceeding US$25 million.
• Proceeds will fund the advancement of Pharmather’s next‑generation ketamine programs while retaining exposure to the broader ketamine market.

Key Details

• Transaction Structure: Sale of ANDA No. 217858 (ketamine hydrochloride injection USP) for a confidential upfront cash payment at closing.
• Milestone & Profit‑Sharing Terms:
• Milestone payments triggered by cumulative sales thresholds (specific amounts not disclosed).
• Ongoing profit sharing on net sales for seven years after the first commercial sale.
• Potential Consideration: More than US$25 million, contingent on product performance; no guarantee that all milestones or profit‑share payments will be realized.
• Buyer Profile: FDA‑approved sterile injectables manufacturer with a portfolio of >40 approved ANDAs in the U.S., operating globally. Buyer remains confidential for strategic reasons.
• Closing Conditions: Subject to customary closing conditions, including required regulatory notifications; expected to close in the near term.
• Use of Proceeds: To fund development of Pharmather’s proprietary next‑generation ketamine therapies (long‑acting injectables and novel delivery methods) targeting psychiatric, pain, neurological, and orphan indications.

Notable Quotes

“This transaction validates the significant value embedded in our ketamine assets,” said Fabio Chianelli, CEO of Pharmather. “It also enables us to leverage the foundation we built with our ketamine program to advance our proprietary next‑generation therapies…”