Medicus Pharma Ltd. Announces Submission of Product Development Plan to the Food and Drug Administration (FDA) to Treat External Squamous Cell Carcinoma (SCC) in Horses

Core Viewpoint - Medicus Pharma Ltd. has submitted a comprehensive product development plan to the FDA to treat external squamous cell carcinoma (SCC) in horses using a novel Doxorubicin-containing microneedle array (D-MNA) patch, aiming for orphan drug designation and a potential market opportunity of $250 million in veterinary oncology [1][5]. Company Developments - The company received a Minor Use in Major Species Designation (MUMS) for its D-MNA in December 2024, which allows for an extended 7-year exclusive marketing period post-approval [2][3]. - The D-MNA is a patented dissolvable transdermal patch designed to deliver Doxorubicin directly to tumors, providing a non-invasive treatment option for equine SCC [4]. Market Opportunity - The veterinary oncology market for treating equine SCC is estimated to be around $250 million, highlighting a significant unmet need in a field with limited approved oncology drugs [5]. Clinical Study Details - The clinical study SKNJCT-004 will enroll up to 50 horses with external SCC, comparing two dose levels of D-MNA against a placebo over a six-month period [9]. - The study will assess the primary effectiveness variable based on a veterinarian's assessment of complete clinical response at day 90 [9]. Previous Clinical Trials - The company previously completed a Phase 1 safety and tolerability study (SKNJCT-001) in humans, which demonstrated good tolerability and efficacy, with 6 out of 13 participants showing complete responses [11]. - A Phase 2 clinical study (SKNJCT-003) is currently underway in the U.S. and has shown promising interim results with over 60% clinical clearance [12]. Expansion Plans - The company is also expanding its clinical trials to Europe and has initiated a study in the UAE, indicating a broader geographical reach for its clinical programs [13][12]. Acquisition Plans - Medicus Pharma has entered into a binding letter of intent to acquire Antev Ltd., a UK-based biotech company, which is developing a next-generation GnRH antagonist for advanced prostate cancer [14][18].