Medicus Pharma's Doxorubin microneedle array received FDA's MUMS designation for treating squamous cell carcinoma in horses.
Quiver AI Summary
Medicus Pharma Ltd. has announced that its Investigational New Animal Drug for a dissolvable Doxorubicin-containing microneedle array (D-MNA) has received Minor Use in Major Species Designation (MUMS) from the FDA, allowing the company exclusive marketing rights for up to seven years upon approval for treating external squamous cell carcinoma (SCC) in horses. This designation, notified on December 9, 2024, is a significant step in Medicus's clinical development efforts and positions the company to capitalize on an underserved market for non-invasive equine SCC treatment. The D-MNA functions by creating microchannels in the skin to deliver chemotherapy directly to tumors. The MUMS designation is seen as a catalyst for Medicus to potentially launch a commercially viable product as early as 2026.
Potential Positives
- Medicus Pharma Ltd. received Minor Use in Major Species Designation (MUMS) from the FDA for its innovative dissolvable Doxorubin-containing microneedle array, enhancing its market position in veterinary medicine.
- The MUMS designation provides a 7-year period of exclusive marketing rights, potentially leading to significant revenue generation once the product is approved.
- The company positions itself as a first mover in a largely untapped market opportunity for treating squamous cell carcinoma in horses, which is estimated to affect 2-3% of the U.S. horse population.
- Encouraging results from previous clinical studies support the efficacy and safety of the D-MNA treatment, paving the way for successful future trials and market introduction.
Potential Negatives
- The press release heavily relies on forward-looking statements, which come with uncertainties and significant risks that could impact the company's future results and stock performance.
- There is no guaranteed timeline for bringing the D-MNA product to market by 2026, and failure to meet this or any other expectations could lead to loss of investor confidence.
- The company mentions ongoing patient recruitment for clinical studies, but does not provide specifics on progress or potential challenges, leaving stakeholders uncertain about the clinical development timeline.
FAQ
What is the MUMS designation received by Medicus Pharma?
The Minor Use in Major Species Designation from the FDA allows extended marketing exclusivity for their D-MNA product in horses.
How does the D-MNA microneedle array work?
The D-MNA penetrates the skin, creates a microchannel, and releases doxorubicin directly into the tumor to treat SCC.
What types of horses are affected by SCC?
SCC primarily affects adult or aged horses with white or partially white coats, especially breeds like Appaloosa and Belgian.
What is the significance of the FDA notification date?
The FDA notified Medicus Pharma about the MUMS designation on December 9, 2024, marking a key milestone for the company.
What are the expected benefits of D-MNA for horses with SCC?
The D-MNA offers a non-invasive treatment option that targets tumors effectively, potentially improving outcomes for horses with SCC.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
TORONTO and PHILADELPHIA, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (TSXV: MDCX) ("Medicus" or the "Company") is pleased to announce that its Investigational New Animal Drug (INAD File No.013880) has received Minor Use in Major Species Designation (“MUMS”) from the U.S. Food and Drug Administration (“FDA”) for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. The company received a notification from the FDA on December 9
th
2024.
MUMS 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.
“In a relatively short period of time, we have made remarkable progress with the FDA in advancing the clinical development program of the veterinary application of our novel D-MNA patch in treating SCC in horses,” stated Dr. Raza Bokhari, Executive Chairman & CEO. “Developing a non-invasive treatment for equine SCC represents an untapped market opportunity that we are excited to pursue. The MUMS designation is an important catalyst to provide us a first mover advantage and also position us to possibly have a commercially viable product as early as 2026.”
Doxorubicin-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.
Squamous Cell Carcinoma (SCC) in Horses
SCC 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 external genitalia. The overall incidence of SCC is 2-3% and recent estimates of the US horse population range from 6.6 to 7.25 million horses.
Current treatment includes surgery to remove the largest mass, cryotherapy of the smaller mass, and local injection of a chemotherapy drug. In some cases, a topical chemotherapeutic drug will be prescribed in the form of drops (tumors near the eye) or cream (tumors in other parts of body). Additionally, some horses are put on an oral drug called piroxicam that may slow the return of the cancerous cells.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jfeffer@lifesciadvisors.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (Nasdaq: MDCX, TSXV: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company submitted a Phase 2 IND clinical protocol to the FDA in January 2024 for a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) that is expected to randomize up to 60 patients. The study is designed to evaluate the efficacy of two dose of two dose levels (100 and 200 ug) of D-MNA compared to placebo (P-MNA) in subjects with nodular BCC. Patient recruitment is currently underway in nine sites across the United States.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company’s plans and expectations concerning, and future outcomes relating to, its product development plans and clinical development programs, including improvements thereto and the timing thereof, and approval from the FDA and the timing thereof. Forward-looking statements are often but not always, identified by the use of such terms as "may", "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on SEDAR+ and on EDGAR, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Readers are cautioned that the foregoing list is not exhaustive and readers are encouraged to review the Company’s long form prospectus accessible on the Company's profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
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