PharmaTher Provides Corporate Update Following FDA Approval of Ketamine (KETARx™)

Core Insights - PharmaTher Holdings Ltd. has received FDA approval for KETARx™, positioning the company for market entry and expansion into rare disorders [2][3] - The company aims to establish a strong ketamine franchise focusing on surgical and diagnostic anesthesia, while also pursuing additional therapeutic applications [2][4] - The global ketamine injectable market is projected to grow from $725 million in 2024 to $3.42 billion by 2034, indicating significant market potential [4] Commercialization Strategy - PharmaTher is implementing a comprehensive strategy for KETARx™ aimed at sustainable growth through strategic partnerships and self-launch capabilities [3][5] - The company is in advanced discussions with specialty pharmaceutical partners to accelerate U.S. and international launches, with a definitive agreement expected by Q4-2025 [5][6] - If no partnership is secured, PharmaTher plans to self-launch KETARx™ leveraging established manufacturing and commercial partners [5] Market Opportunity - The U.S. market has approximately 50-55 million surgical procedures and 23-24 million diagnostic procedures annually that utilize anesthesia, representing high-value access points for KETARx™ [4] - The increasing number of surgical and diagnostic procedures, driven by an aging population and rising chronic diseases, creates robust demand for KETARx™ [4] - The FDA's increasing openness to real-world evidence supports a fast-follower strategy under the 505(b)(2) pathway for rare disorders [4][7] Regulatory Pathway - PharmaTher is pursuing additional FDA approvals for KETARx™ to address rare disorders, leveraging orphan drug designations to enhance market exclusivity [7][8] - The company plans to submit a New Drug Application (NDA) for Complex Regional Pain Syndrome (CRPS) by the end of Q4-2025, with a potential Prescription Drug User Fee Act (PDUFA) date by Q4-2026 [8][9] - PharmaTher holds five FDA orphan drug designations for ketamine, each representing distinct opportunities for market exclusivity [8] Future Plans - The company intends to submit another NDA for KETARx™ to treat a different rare disorder by Q1-2026, with details to be released closer to the filing [10] - PharmaTher is strategically focused on advancing ketamine for rare disorders, avoiding non-orphan indications to maintain competitive advantages [11]