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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
Company Is Advancing Use of Novel Doxorubicin-containing Microneedle Array (D-MNA) Patch in Veterinary Oncology as an Orphan Drug Philadelphia,
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"Company Is Advancing Use of Novel Doxorubicin-containing Microneedle Array (D-MNA) Patch in Veterinary Oncology as an Orphan Drug\nPhiladelphia, Pennsylvania--(Newsfile Corp. - June 9, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) (\"Medicus\" or the \"Company\") is pleased to announce submission of a comprehensive product development plan to treat external squamous cell carcinoma (SCC) under Investigational New Animal Drug (INAD File No.013880).\nThe Company, in December 2024, received a Minor Use in Major Species Designation (MUMS) for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. The product development plan is designed to seek concurrence of the FDA under MUMS designation.\nMUMS is a status similar to Orphan Drug status for human drugs. It entitles the Company to an extended 7-year period of exclusive marketing following approval or conditional approval, provided that the Company meets all requirements for maintaining the designation.\nDoxorubicin-containing microneedle array (D-MNA) is a patent protected dissovable transdermal patch with cellulose based microneedle arrays that are tip-loaded with doxorubicin. After application, the microneedles function by penetrating the strateum corneum layer of the skin, create a temporary microchannel, penetrate the tumor, dissolve and release doxorubicin into the target tumor, and eradicate the cancer cells.\n\"In Veterinary Medicine, where there are only a handful of approved oncology drugs, we believe developing a non-invasive treatment for equine SCC represents an untapped and unmet market opportunity potentially in the range of $250 million,\" stated Dr. Raza Bokhari, Executive Chairman & CEO. \"The submission to the FDA of a novel product development program may provide us a first mover advantage and sets the stage to consider other companion animal species and types of cancer.\"\nSquamous Cell Carcinoma (SCC) in Horses\nSCC is a mucocutaneous skin tumor in horses, primarily affecting adult or aged horses with white or partially white coats. Breeds like Appaloosa, Belgian, American Paint, and Pinto are particularly susceptible. SCC often develops in areas with minimal pigmentation and sparse hair, notably around mucous membranes. More specifically, tumors are mainly seen around the eyes, lips, nose, anus, and...