Pharmather clarifies sale of one generic ketamine asset

Executive Summary

• Pharmather sold its abbreviated new drug application (ANDA) for generic ketamine hydrochloride injection to a global pharmaceutical partner, generating non‑dilutive capital tied to U.S. sales.
• The transaction does not affect Pharmather’s broader proprietary ketamine pipeline (Parkinson’s disease, ALS, CRPS, microneedle patch, wearable pump).
• Over the next six months the company will pursue international partnerships, engage the FDA on expedited pathways for CRPS and Parkinson’s programs, and position these assets for further partnership or licensing opportunities.

Key Details

• Asset Sold: ANDA No. 217858 for ketamine hydrochloride injection USP (generic).
• Transaction Nature: Strategic sale to a well‑established global pharma company specializing in sterile injectables; terms remain confidential.
• Capital Impact: Provides non‑dilutive financing linked solely to U.S. commercial sales of the generic product.
• Retention of Portfolio: Pharmather retains all other ketamine‑based programs, including:
• Parkinson’s disease program (505(b)(2) pathway).
• Amyotrophic lateral sclerosis (ALS) program.
• Complex regional pain syndrome (CRPS) program.
• Ketamine microneedle patch.
• Wearable pump for mental health, neurological and pain disorders.
• Strategic Rationale: Avoids the high capital, inventory, and sales‑force requirements of launching a generic ketamine injectable; leverages partner’s manufacturing scale, regulatory record, and commercial infrastructure.
• CMC Benefit: The CMC package developed for the ANDA will be reused for future proprietary NDAs, potentially reducing development time and cost.
• Regulatory Constraints: Pharmather will not develop, file, or seek approval for a product identical to the sold ANDA; future products will be differentiated.
• Next‑Six‑Month Initiatives:
• Pursuing new global partnerships for additional non‑dilutive financing.
• Planning FDA meetings to define expedited clinical/regulatory pathways for CRPS and to agree on Phase 3 design for Parkinson’s disease.
• Positioning CRPS and Parkinson’s programs as attractive partnership candidates, alongside microneedle patch and wearable pump technologies.

Notable Quotes

“Our investment in developing the ketamine ANDA was a strategic move, designed not only for near‑term monetization but also to establish a long‑term foundation for our proprietary ketamine pipeline.” – Fabio Chianelli, CEO, Pharmather Holdings Ltd.