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TORONTO, June 24, 2025 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (“PharmaTher” or the “Company”), a company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,128,012, expiring May 14, 2041, for the use of ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS).
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This newly issued patent significantly strengthens the Company’s intellectual property portfolio and provides robust protection for its clinical development program for ketamine in ALS. This achievement complements PharmaTher’s existing Orphan Drug Designation (ODD) for ketamine, granted by the U.S. Food and Drug Administration (FDA), creating a powerful strategic advantage in addressing this devastating neurodegenerative disease.
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“The grant of this U.S. patent is a monumental achievement for PharmaTher and a critical step in solidifying our leadership position in developing novel ketamine therapies for severe neurological disorders,” said Fabio Chianelli, CEO of PharmaTher. “Combined with our Orphan Drug Designation, we have built a formidable moat around our ketamine program for ALS. This dual protection of intellectual property and regulatory exclusivity is a cornerstone of our strategy to unlock significant shareholder value as we advance towards clinical development and potential commercialization for a patient population with an urgent unmet medical need.”
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The Unmet Need in ALS: A Devastating Disease
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Amyotrophic Lateral Sclerosis, often known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder that affects nerve cells in the brain and spinal cord. ALS leads to the gradual loss of muscle control, impacting the ability to speak, eat, move, and eventually breathe. Currently, there is no cure for ALS, and existing treatments offer only modest benefits in slowing disease progression, highlighting a desperate need for new and more effective therapeutic options.
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Market Opportunity and Strategic Advantage
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The market for ALS treatments represents a significant commercial opportunity, driven by a high unmet need and a dedicated patient advocacy community.
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- Incidence & Population: Approximately 5,000 new cases of ALS are diagnosed each year in the U.S., with an estimated 30,000 people currently living with the disease in the United States alone.
- Market Size: The global ALS treatment market is projected to reach over USD $1.04 billion by 2030, according to projections from Precedence Research, with the potential to grow substantially with the introduction of novel, disease-modifying therapies.
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PharmaTher’s strategy is uniquely positioned to capture this market. The combination of the new patent and the FDA Orphan Drug Designation creates a powerful value proposition:
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- Patent Protection: The newly granted patent provides long-term (patent expiry May 14, 2041), defensible intellectual property rights for the Company’s specific method of using ketamine to treat ALS.
- FDA Orphan Drug Designation (ODD): The ODD provides powerful incentives, including:
- Seven years of market exclusivity in the U.S. following drug approval.
- Tax credits for qualified clinical trials.
- Exemption from FDA application fees of approximately $2.4 million
- Regulatory guidance and assistance from the FDA.
- FDA Fast Track Designation and Clinical Study: The FDA had accepted an investigator-initiated IND to proceed with a Phase 2 clinical study evaluating ketamine for ALS. The study’s primary investigator is Dr. Richard Barohn, M.D. Upon completion of the study, the Company will seek FDA Fast Track designation and meeting for a proposed Phase 3 study in 2026.
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