Medicus Pharma Explores Innovative Treatments with FDA Support

Exciting Progress for Medicus Pharma Ltd.

Medicus Pharma Ltd. (NASDAQ: MDCX) has made significant strides in the veterinary field by receiving Minor Use in Major Species (MUMS) designation from the FDA. This designation pertains to their innovative Doxorubicin-containing microneedle array (D-MNA) patch designed to combat external squamous cell carcinoma (SCC) in horses.

Understanding Minor Use in Major Species Designation

MUMS designation represents a crucial status akin to Orphan Drug status, primarily aimed at facilitating drug development for lesser-known conditions in significant animal populations. This unique status grants Medicus a valuable extended marketing period of seven years once the product gains approval or conditional approval. Achieving this designation showcases the company's commitment to advancing veterinary medicines and demonstrates their potential to shape a profitable market segment.

Strategic Insights from Leadership

Dr. Raza Bokhari, Executive Chairman & CEO of Medicus, articulated the company's vision clearly: "By developing a non-invasive treatment for equine SCC, we are exploring a previously untapped market opportunity we are eager to pursue. The MUMS designation will significantly enhance our market positioning, giving us a first-mover advantage while potentially allowing us to launch a commercially viable product as soon as 2026."

Innovative Approach: The Doxorubicin Microneedle Array

The D-MNA is a novel, patented dissolvable transdermal patch that uses cellulose-based microneedles. These microneedles are designed to penetrate the outer skin layer and deliver doxorubicin directly into the tumor site. This targeted approach may lead to significantly improved outcomes in treating cancerous tumors while minimizing invasiveness.

What is Squamous Cell Carcinoma (SCC)?

SCC is a serious skin tumor affecting horses, especially those with lighter coats. Breeds like Appaloosa, Belgian, American Paint, and Pinto are notably more prone to developing these tumors, often found in areas with minimal pigmentation, such as around the eyes or jaws. The prevalence of SCC in the overall horse population ranges between 2% and 3%, highlighting a considerable need for effective treatment options.

Current Treatment Options and Their Limitations

Presently, horses diagnosed with SCC primarily undergo surgery to remove visible growths. Other common treatments include cryotherapy for smaller tumors and localized injections of chemotherapy drugs. Additionally, topical treatments like creams and drops are sometimes prescribed, particularly for tumors located near sensitive areas such as the eyes. In some instances, oral medications like piroxicam help manage the condition in certain patients.

Looking Ahead: Medicus Pharma's Commitment to Innovation

Beyond the D-MNA patch, Medicus Pharma Ltd. is dedicated to broadening the horizon of treatment options for both human and veterinary medicine. The company's subsidiary, SkinJect Inc., focuses on developing pain-free therapies targeting basal cell skin cancer using innovative microneedle technology.

Recent Developments and Future Plans

SkinJect has recently completed a Phase 1 safety and tolerability study with promising outcomes, suggesting its products may offer significant benefits to patients. A Phase 2 IND clinical protocol was submitted to the FDA, aiming to assess the efficacy of varying D-MNA doses in patients with nodular basal cell carcinoma. This rigorous research aims to enhance treatment protocols and increase the company's portfolio of market-ready therapeutics.

Contact Information for Further Inquiries

For more insights about Medicus Pharma's advancements in veterinary treatment or their innovative technology, please reach out to:

Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com

Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jfeffer@lifesciadvisors.com

Frequently Asked Questions

What is the significance of the MUMS designation for Medicus Pharma?

The MUMS designation allows Medicus Pharma to enjoy an extended period of exclusive marketing for its veterinary drug, enhancing their chances for a successful product launch.

How does the D-MNA patch work to treat SCC in horses?

The D-MNA patch uses microneedles to deliver doxorubicin directly into the tumor, allowing for a targeted and less invasive treatment method.

What are the current treatment options for horses with SCC?

Current treatments include surgery, cryotherapy, topical medications, and oral medications such as piroxicam.

What are the main breeds of horses susceptible to SCC?

Breeds like Appaloosa, Belgian, American Paint, and Pinto are particularly prone to developing squamous cell carcinoma.

What is SkinJect Inc. focusing on in its research?

SkinJect Inc. concentrates on developing non-invasive treatments for basal cell skin cancer using patented dissolvable microneedle patches.

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