Medicus Pharma Ltd. Announces Minor Use (MUMS) Designation from the FDA for Doxorubicin-Containing Microneedle Array (D-MNA) Patch
Medicus Pharma (NASDAQ: MDCX) has received Minor Use in Major Species (MUMS) Designation from the FDA for its Doxorubicin-containing microneedle array (D-MNA) patch to treat external squamous cell carcinoma (SCC) in horses. The MUMS status, similar to Orphan Drug designation for human drugs, grants a 7-year exclusive marketing period post-approval.
The D-MNA is a patent-protected dissolvable transdermal patch using cellulose-based microneedles loaded with doxorubicin to penetrate and treat skin tumors. The company plans to target the equine SCC market, which affects 2-3% of the US horse population of 6.6-7.25 million horses, particularly in breeds with white or partially white coats. Medicus aims to have a commercially viable product by 2026.
Medicus Pharma (NASDAQ: MDCX) ha ricevuto la designazione Minor Use in Major Species (MUMS) dalla FDA per il suo cerotto a microneedle contenente Doxorubicina (D-MNA) per il trattamento del carcinoma squamoso esterno (SCC) nei cavalli. Lo stato MUMS, simile alla designazione di Farmaco Orfano per i farmaci umani, concede un periodo esclusivo di commercializzazione di 7 anni dopo l'approvazione.
Il D-MNA è un cerotto transdermico dissolvibile protetto da brevetto, che utilizza microneedle a base di cellulosa caricate di doxorubicina per penetrare e trattare i tumori cutanei. L'azienda prevede di indirizzarsi al mercato del SCC equino, che colpisce il 2-3% della popolazione equina statunitense di 6.6-7.25 milioni di cavalli, in particolare nelle razze con mantello bianco o parzialmente bianco. Medicus punta ad avere un prodotto commercialmente valido entro il 2026.
Medicus Pharma (NASDAQ: MDCX) ha recibido la designación de Uso Menor en Especies Mayores (MUMS) por parte de la FDA para su parche de microagujas que contiene Doxorubicina (D-MNA) para tratar el carcinoma de células escamosas externas (SCC) en caballos. El estado MUMS, similar a la designación de Medicamento Huérfano para medicamentos humanos, otorga un periodo exclusivo de comercialización de 7 años tras la aprobación.
El D-MNA es un parche transdérmico disoluble protegido por patente que utiliza microagujas a base de celulosa cargadas de doxorubicina para penetrar y tratar tumores cutáneos. La empresa planea dirigirse al mercado de SCC equino, que afecta al 2-3% de la población de caballos en EE. UU. de 6.6-7.25 millones, en particular en razas con pelajes blancos o parcialmente blancos. Medicus tiene como objetivo tener un producto comercialmente viable para 2026.
메디커스 파마 (NASDAQ: MDCX)는 FDA로부터 말의 외부 편평 세포 암종(SCC) 치료를 위한 독소루비신이 포함된 마이크로니들 패치(D-MNA)에 대한 소규모 사용(청취대상) 지정(MUMS)을 받았습니다. MUMS 상태는 인간 약물의 고아약 지정과 유사하며, 승인이 난 후 7년간의 독점 판매 기간을 부여합니다.
D-MNA는 독소루비신을 주입하여 피부 종양을 침투하고 치료하기 위해 셀룰로오스 기반의 마이크로니들로 구성된 특허 보호받는 용해성 경피 패치입니다. 이 회사는 660만에서 725만 마리의 미국 말 인구 중 2-3%에 영향을 미치는 말 SCC 시장을 겨냥할 계획이며, 특히 흰색 또는 부분적으로 흰색 코트를 가진 품종에 집중할 것입니다. 메디커스는 2026년까지 상업적으로 유효한 제품을 갖출 계획입니다.
Medicus Pharma (NASDAQ: MDCX) a reçu la désignation d'Usage Mineur dans des Espèces Majeures (MUMS) de la FDA pour son patch à microneedles contenant de la Doxorubicine (D-MNA) destiné à traiter les carcinomes épidermoïdes externes (SCC) chez les chevaux. Le statut MUMS, similaire à la désignation de Médicament Orphelin pour les médicaments humains, accorde une période de commercialisation exclusive de 7 ans après l'approbation.
Le D-MNA est un patch transdermique soluble protégé par un brevet, utilisant des microneedles à base de cellulose chargées de doxorubicine pour pénétrer et traiter les tumeurs cutanées. L'entreprise prévoit de cibler le marché des SCC équins, qui affecte 2-3% de la population de chevaux aux États-Unis, soit 6,6 à 7,25 millions de chevaux, en particulier chez les races ayant des pelages blancs ou partiellement blancs. Medicus vise à avoir un produit commercialement viable d'ici 2026.
Medicus Pharma (NASDAQ: MDCX) hat von der FDA die Klassifizierung als Minor Use in Major Species (MUMS) für sein Doxorubicin-haltiges Mikronadel-Patch (D-MNA) zur Behandlung von externem Plattenepithelkarzinom (SCC) bei Pferden erhalten. Der MUMS-Status, der dem Orphan Drug-Status für menschliche Arzneimittel ähnelt, gewährt eine exklusive Vermarktungsdauer von 7 Jahren nach der Genehmigung.
Das D-MNA ist ein patentgeschütztes, lösliches transdermales Pflaster, das mit Doxorubicin beladene, aus Cellulose bestehende Mikronadeln verwendet, um Hauttumore zu durchdringen und zu behandeln. Das Unternehmen plant, den Markt für equines SCC anzusprechen, der 2-3% der US-Pferdepopulation von 6,6-7,25 Millionen Pferden betrifft, insbesondere bei Rassen mit weißem oder teilweise weißem Fell. Medicus strebt an, bis 2026 ein marktfähiges Produkt zu haben.
- Received MUMS designation granting 7-year market exclusivity
- Patent protection for D-MNA technology
- Potential market size of 132,000-217,500 horses (2-3% of US horse population)
- Targeted commercial launch by 2026
- Product still requires FDA approval/conditional approval
- to veterinary application in horses only
Insights
The FDA's MUMS designation for Medicus Pharma's D-MNA patch represents a significant regulatory milestone in the veterinary medicine space. The designation, analogous to Orphan Drug status in human therapeutics, provides 7 years of market exclusivity post-approval - a substantial competitive advantage in the equine SCC treatment market.
The technology's potential market reach is noteworthy, with SCC affecting 2-3% of the US horse population of 6.6-7.25 million. Current treatment options are invasive or have efficacy, making this non-invasive patch technology particularly promising. The
The MUMS designation significantly enhances Medicus Pharma's market position in the veterinary oncology space. With potential commercialization by 2026, the company is establishing a first-mover advantage in an untapped market segment. The addressable market is substantial - considering the US horse population and SCC incidence rate, this represents approximately 130,000-217,500 potential cases.
For a company with a market cap of
Company to Submit Product Development Plan to Treat External Squamous Cell Carcinoma (SCC) in Horses
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 9th 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
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.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FAQ
What is the market potential for MDCX's D-MNA patch for equine SCC treatment?
When does Medicus Pharma (MDCX) expect to launch its D-MNA patch commercially?
What benefits does the MUMS designation provide to MDCX?
How does MDCX's D-MNA patch technology work for treating horse SCC?
