PharmaTher Secures Key US Patent for Ketamine in Amyotrophic Lateral Sclerosis (ALS), Bolstering its Orphan Drug Designated Program and Targeting a Billion Dollar Market
PharmaTher Holdings (OTCQB: PHRRF) has secured a crucial U.S. patent (No. 12,128,012) for using ketamine to treat Amyotrophic Lateral Sclerosis (ALS), valid until May 14, 2041. This patent complements their existing FDA Orphan Drug Designation, strengthening their market position in treating this fatal neurodegenerative disorder.
The company is targeting the global ALS treatment market, projected to reach $1.04 billion by 2030. With approximately 5,000 new ALS cases diagnosed annually in the U.S. and 30,000 current patients, PharmaTher is advancing towards Phase 2 clinical trials, with plans for FDA Fast Track designation and Phase 3 studies in 2026.
The combination of patent protection and Orphan Drug status provides PharmaTher with significant advantages, including seven years of market exclusivity, tax credits for clinical trials, and FDA application fee exemptions worth approximately $2.4 million.
PharmaTher Holdings (OTCQB: PHRRF) ha ottenuto un brevetto statunitense fondamentale (n. 12.128.012) per l'uso della ketamina nel trattamento della Sclerosi Laterale Amiotrofica (SLA), valido fino al 14 maggio 2041. Questo brevetto integra la loro attuale Designazione di Farmaco Orfano FDA, rafforzando la loro posizione nel mercato per il trattamento di questa grave malattia neurodegenerativa.
L'azienda punta al mercato globale dei trattamenti per la SLA, previsto raggiungere 1,04 miliardi di dollari entro il 2030. Con circa 5.000 nuovi casi di SLA diagnosticati ogni anno negli Stati Uniti e 30.000 pazienti attuali, PharmaTher sta avanzando verso la fase 2 degli studi clinici, con piani per la designazione FDA Fast Track e studi di fase 3 nel 2026.
La combinazione della protezione brevettuale e dello status di Farmaco Orfano offre a PharmaTher vantaggi significativi, tra cui sette anni di esclusività di mercato, crediti d'imposta per gli studi clinici ed esenzioni dalle tasse di applicazione FDA per un valore di circa 2,4 milioni di dollari.
PharmaTher Holdings (OTCQB: PHRRF) ha asegurado una patente crucial en EE.UU. (No. 12,128,012) para el uso de ketamina en el tratamiento de la Esclerosis Lateral Amiotrófica (ELA), válida hasta el 14 de mayo de 2041. Esta patente complementa su actual Designación de Medicamento Huérfano por la FDA, fortaleciendo su posición en el mercado para tratar este trastorno neurodegenerativo fatal.
La compañía apunta al mercado global de tratamiento de la ELA, proyectado para alcanzar los 1.04 mil millones de dólares para 2030. Con aproximadamente 5,000 nuevos casos de ELA diagnosticados anualmente en EE.UU. y 30,000 pacientes actuales, PharmaTher avanza hacia ensayos clínicos de fase 2, con planes para la designación Fast Track de la FDA y estudios de fase 3 en 2026.
La combinación de la protección de la patente y el estatus de Medicamento Huérfano proporciona a PharmaTher ventajas significativas, incluyendo siete años de exclusividad en el mercado, créditos fiscales para ensayos clínicos y exenciones en las tarifas de aplicación de la FDA por un valor aproximado de 2.4 millones de dólares.
PharmaTher Holdings (OTCQB: PHRRF)는 근위축성 측삭 경화증(ALS) 치료를 위한 케타민 사용에 관한 중요한 미국 특허(No. 12,128,012)를 확보했으며, 이 특허는 2041년 5월 14일까지 유효합니다. 이 특허는 FDA 희귀의약품 지정과 함께 치명적인 신경퇴행성 질환 치료 시장에서의 입지를 강화합니다.
회사는 2030년까지 10억 4천만 달러에 이를 것으로 예상되는 글로벌 ALS 치료 시장을 목표로 하고 있습니다. 미국 내 연간 약 5,000건의 신규 ALS 진단 사례와 30,000명의 현재 환자를 바탕으로 PharmaTher는 2상 임상시험을 진행 중이며, FDA 패스트 트랙 지정과 2026년 3상 연구를 계획하고 있습니다.
특허 보호와 희귀의약품 지위의 결합은 PharmaTher에 7년간의 시장 독점권, 임상시험 세액공제, 약 240만 달러 상당의 FDA 신청 수수료 면제 등 중요한 이점을 제공합니다.
PharmaTher Holdings (OTCQB : PHRRF) a obtenu un brevet américain crucial (n° 12,128,012) pour l'utilisation de la kétamine dans le traitement de la sclérose latérale amyotrophique (SLA), valable jusqu'au 14 mai 2041. Ce brevet complète leur désignation actuelle de médicament orphelin de la FDA, renforçant leur position sur le marché pour traiter cette maladie neurodégénérative mortelle.
L'entreprise vise le marché mondial du traitement de la SLA, dont la valeur devrait atteindre 1,04 milliard de dollars d'ici 2030. Avec environ 5 000 nouveaux cas de SLA diagnostiqués chaque année aux États-Unis et 30 000 patients actuels, PharmaTher progresse vers les essais cliniques de phase 2, avec des plans pour une désignation Fast Track de la FDA et des études de phase 3 en 2026.
La combinaison de la protection par brevet et du statut de médicament orphelin offre à PharmaTher des avantages significatifs, notamment sept ans d'exclusivité sur le marché, des crédits d'impôt pour les essais cliniques et des exonérations des frais de dossier FDA d'une valeur d'environ 2,4 millions de dollars.
PharmaTher Holdings (OTCQB: PHRRF) hat ein wichtiges US-Patent (Nr. 12.128.012) für die Verwendung von Ketamin zur Behandlung der Amyotrophen Lateralsklerose (ALS) erhalten, gültig bis zum 14. Mai 2041. Dieses Patent ergänzt ihre bestehende FDA Orphan Drug Designation und stärkt ihre Marktposition bei der Behandlung dieser tödlichen neurodegenerativen Erkrankung.
Das Unternehmen zielt auf den globalen ALS-Behandlungsmarkt ab, der bis 2030 voraussichtlich 1,04 Milliarden US-Dollar erreichen wird. Mit etwa 5.000 neuen ALS-Diagnosen jährlich in den USA und 30.000 aktuellen Patienten schreitet PharmaTher in Richtung Phase-2-Studien voran, mit Plänen für eine FDA Fast Track-Zulassung und Phase-3-Studien im Jahr 2026.
Die Kombination aus Patentschutz und Orphan-Drug-Status bietet PharmaTher erhebliche Vorteile, darunter sieben Jahre Marktexklusivität, Steuergutschriften für klinische Studien und Befreiungen von FDA-Antragsgebühren im Wert von etwa 2,4 Millionen US-Dollar.
- Secured U.S. patent protection until May 14, 2041 for ketamine use in ALS treatment
- FDA Orphan Drug Designation provides 7 years of market exclusivity and significant financial benefits
- Targeting a growing market projected to reach $1.04 billion by 2030
- FDA accepted investigator-initiated IND for Phase 2 clinical study
- Multiple layers of protection through patent and regulatory exclusivity strengthen market position
- Currently in early clinical stages with Phase 2 trials pending
- Faces competition in a market with existing treatments
- Long development pathway with Phase 3 studies not planned until 2026
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).
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.
“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.”
The Unmet Need in ALS: A Devastating Disease
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.
Market Opportunity and Strategic Advantage
The market for ALS treatments represents a significant commercial opportunity, driven by a high unmet need and a dedicated patient advocacy community.
- 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.
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:
- 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.
Mr. Chianelli added, “Our robust strategy is designed to de-risk the development pathway and maximize the commercial potential of ketamine for ALS. We are now in a strong position to advance our clinical program, pursue strategic partnerships, and ultimately deliver a potentially life-altering therapy to patients.”
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and nine months ended February 28, 2025 dated April 24, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
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