UroGen Receives New U.S. Patent Allowance for Next-Generation Mitomycin-Based Products Expected to Provide Protection Until December 2041
UroGen Pharma (Nasdaq: URGN) has received a Notice of Allowance from the USPTO for a patent application covering its RTGel® technology combined with medac's lyophilized mitomycin formulation. This patent, set to expire in December 2041, will protect UroGen's UGN-103 and UGN-104 development programs for treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively.
The company believes this combination has potential advantages in production, cost, supply, and patient convenience. UroGen recently entered a licensing agreement with medac for these programs, and the FDA has accepted the IND application for UGN-103. Clinical sites are being onboarded for the UGN-103 study, with a similar study for UGN-104 expected to commence in early 2025.
UroGen Pharma (Nasdaq: URGN) ha ricevuto un Avviso di Concessione dall'USPTO per una domanda di brevetto che copre la sua tecnologia RTGel® combinata con la formulazione di mitomicina liofilizzata di medac. Questo brevetto, che scadrà a dicembre 2041, proteggerà i programmi di sviluppo UGN-103 e UGN-104 di UroGen per il trattamento del carcinoma vescicale non muscolo invasivo a rischio intermedio di basso grado (LG-IR-NMIBC) e del carcinoma uroteliale dell'uretere superiore a basso grado (LG-UTUC), rispettivamente.
La società crede che questa combinazione abbia vantaggi potenziali in termini di produzione, costi, rifornimenti e comodità per i pazienti. UroGen ha recentemente stipulato un accordo di licenza con medac per questi programmi, e la FDA ha accettato la domanda IND per UGN-103. Sono in fase di onboarding i siti clinici per lo studio di UGN-103, con uno studio simile per UGN-104 previsto per l'inizio del 2025.
UroGen Pharma (Nasdaq: URGN) ha recibido un Aviso de Concesión de la USPTO para una solicitud de patente que cubre su tecnología RTGel® combinada con la formulación de mitomicina liofilizada de medac. Esta patente, que vencerá en diciembre de 2041, protegerá los programas de desarrollo UGN-103 y UGN-104 de UroGen para el tratamiento del cáncer de vejiga no muscular invasivo de bajo grado y riesgo intermedio (LG-IR-NMIBC) y del cáncer urotelial de las vías urinarias superiores de bajo grado (LG-UTUC), respectivamente.
La empresa cree que esta combinación tiene posibles ventajas en producción, costos, suministro y comodidad para los pacientes. UroGen firmó recientemente un acuerdo de licencia con medac para estos programas, y la FDA ha aceptado la solicitud IND para UGN-103. Se están incorporando sitios clínicos para el estudio de UGN-103, con un estudio similar para UGN-104 que se espera comience a principios de 2025.
UroGen Pharma (Nasdaq: URGN)는 USPTO로부터 RTGel® 기술과 medac의 리오필라이즈드 미코마이신 제형을 결합한 특허 출원에 대한 허가 공지를 받았습니다. 이 특허는 2041년 12월에 만료될 예정이며, UroGen의 UGN-103 및 UGN-104 개발 프로그램을 저등급 중간 위험 비근육 침습성 방광암 (LG-IR-NMIBC) 및 저등급 상부 요로 유두암 (LG-UTUC) 치료를 위해 보호할 것입니다.
회사는 이 조합의 생산, 비용, 공급 및 환자 편의성 측면에서 잠재적인 이점이 있다고 믿고 있습니다. UroGen은 최근 medac과 이러한 프로그램에 대한 라이센스 계약을 체결했으며, FDA는 UGN-103에 대한 IND 신청서를 수락했습니다. UGN-103 연구를 위한 임상 사이트가 온보딩 중이며, UGN-104에 대한 유사한 연구는 2025년 초에 시작될 것으로 예상됩니다.
UroGen Pharma (Nasdaq: URGN) a reçu un Avis de Permis de l'USPTO pour une demande de brevet couvrant sa technologie RTGel® associée à la formulation de mitomycine lyophilisée de medac. Ce brevet, qui expirera en décembre 2041, protégera les programmes de développement UGN-103 et UGN-104 d'UroGen pour le traitement du cancer de la vessie non invasif à faible grade et risque intermédiaire (LG-IR-NMIBC) et du cancer urotélial des voies urinaires supérieures à faible grade (LG-UTUC), respectivement.
L'entreprise pense que cette combinaison présente des avantages potentiels en matière de production, de coût, d'approvisionnement et de commodité pour les patients. UroGen a récemment conclu un accord de licence avec medac pour ces programmes, et la FDA a accepté la demande IND pour UGN-103. Des sites cliniques sont en cours d'intégration pour l'étude UGN-103, une étude similaire pour UGN-104 étant prévue pour début 2025.
UroGen Pharma (Nasdaq: URGN) hat eine Zulassungsmitteilung vom USPTO für einen Patentantrag erhalten, der seine RTGel®-Technologie in Kombination mit der lyophilisierten Mitomycin-Formulierung von medac abdeckt. Dieses Patent, das im Dezember 2041 abläuft, wird die Entwicklungsprogramme UGN-103 und UGN-104 von UroGen zum Behandlung von nicht-muskelinvasivem Blasenkrebs mit niedriggradigem intermediärem Risiko (LG-IR-NMIBC) und nicht-muskelinvasivem Urothelkarzinom der oberen Harnwege (LG-UTUC) schützen.
Das Unternehmen ist der Ansicht, dass diese Kombination potenzielle Vorteile in Bezug auf Produktion, Kosten, Versorgung und Patientenkomfort bietet. UroGen hat kürzlich einen Lizenzvertrag mit medac für diese Programme abgeschlossen, und die FDA hat den IND-Antrag für UGN-103 angenommen. Klinische Standorte werden für die UGN-103-Studie eingearbeitet, wobei eine ähnliche Studie für UGN-104 Anfang 2025 beginnen soll.
- Patent allowance strengthens intellectual property position until December 2041
- Potential advantages in production, cost, supply, and patient convenience
- FDA acceptance of IND application for UGN-103
- Ongoing preparation for UGN-103 clinical study
- Planned UGN-104 study expected to start in early 2025
- None.
This patent allowance significantly bolsters UroGen's intellectual property portfolio, providing important protection for their next-generation mitomycin-based products until December 2041. The extended exclusivity period is a major asset for UroGen, potentially deterring competitors and securing market advantage for nearly two decades.
The patent's scope, covering the combination of UroGen's RTGel® technology with medac's lyophilized mitomycin formulation, is particularly broad and valuable. It encompasses both UGN-103 and UGN-104 programs, targeting different types of urothelial cancers. This comprehensive coverage enhances UroGen's position in the urothelial cancer treatment landscape.
From a strategic perspective, this patent allowance aligns perfectly with UroGen's recent licensing agreement with medac, creating a synergistic effect that could accelerate product development and commercialization efforts.
The potential advantages of UroGen's RTGel® technology combined with medac's lyophilized mitomycin formulation are significant for urothelial cancer treatment. This combination could offer improved drug delivery and increased efficacy compared to current standards of care.
For patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), these developments may lead to more effective and convenient treatment options. The potential for improved production, cost, supply and product convenience could translate to better patient outcomes and quality of life.
The FDA's acceptance of the IND application for UGN-103 and the planned study for UGN-104 indicate promising progress in bringing these innovative treatments to patients. This could represent a significant advancement in the field of urothelial cancer therapy.
This patent allowance strengthens UroGen's market position and potential revenue streams. The extended protection until 2041 provides a long runway for commercialization and return on investment, which is important in the biotech sector where development cycles are lengthy and costly.
The company's strategic moves, including the licensing agreement with medac and the progress of UGN-103 and UGN-104, demonstrate a clear path to value creation. The potential advantages in production, cost and supply could lead to improved margins and competitive pricing.
Investors should note the positive momentum in UroGen's pipeline, with the FDA accepting the IND for UGN-103 and plans for UGN-104 studies. These developments, coupled with the patent protection, could significantly de-risk the company's future revenue potential and make it an attractive target for partnerships or acquisitions in the urothelial cancer space.
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Once issued, this patent provides
U.S. intellectual property coverage of UroGen’s RTGel® technology with medac lyophilized mitomycin formulation, covering UGN-103 and UGN-104 development programs until December 2041
The allowed claims relate to the combination of UroGen’s RTGel® technology with medac’s licensed proprietary lyophilized mitomycin formulation and cover the use of UroGen’s UGN-103 and UGN-104 development programs in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively. The
“Allowance of this patent application strengthens our intellectual property position for our next-generation investigational programs for patients with urothelial cancers,” said Liz Barrett, President and CEO of UroGen. “We believe that the combination of UroGen’s RTGel® technology with medac’s patent-protected lyophilized mitomycin has the potential to provide advantages related to production, cost, supply, and product convenience for patients. Our vision remains to develop innovative medicines that advance the care of patients, and this patent allowance is a key element of our strategy to build a long-term growth company.”
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for LG-IR-NMIBC and UGN-104 for LG-UTUC. In April 2024, the FDA accepted UroGen’s IND application for UGN-103 and the company is currently onboarding clinical sites for the study. The company anticipates commencing a similar study for UGN-104, which is expected in early 2025.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission for UGN-102 in August 2024, ahead of schedule. UroGen anticipates potential FDA approval in early 2025 if the NDA is accepted for filing by the FDA and priority review is granted.
About UGN-103 and UGN-104
UGN-103 and UGN-104 are innovative mitomycin formulations in development by UroGen for the treatment of LG-IR-NMIBC and LG-UTUC, respectively. UGN-103 aims to streamline manufacturing and reconstitution processes while providing intellectual property coverage until December 2041; it utilizes UroGen’s RTGel® technology for prolonged mitomycin exposure. UGN-104, also leveraging RTGel® technology, is designed for treating low-grade upper tract urothelial cancer and is anticipated to enter Phase 3 trials in early 2025, offering a non-surgical treatment option with similar intellectual property protection.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained-release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in
About medac
At medac group, we believe that health is humanity’s most valuable resource. Since 1970, our mission has been to improve patients’ quality of life worldwide by making the best medical treatments available. As a globally operating pharmaceutical company headquartered in
Our products are manufactured in
We are constantly working to improve authorized medicines and to develop innovative therapies in the fields of rheumatology, urology, hematology, and oncology. Part of our mission is to provide safe, high-quality and innovative original products, as well as generics and biosimilars. In this way, we make vital treatments accessible to those affected.
Further information on the company can be found online at www.medac-group.com.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: anticipated intellectual property protection; the potential for UGN-103 and UGN-104 to combine UroGen’s RTGel® technology with medac’s proprietary formulation to introduce new non-surgical treatment options for LG-IR-NMIBC and LG-UTUC, respectively; the belief that the combination of UroGen’s RTGel® technology with medac’s proprietary formulation could provide several advantages related to production, cost, supply, and product convenience; the timing for the planned Phase 3 trial of UGN-103 and UGN-104 and the potential approval of both drug candidates; the anticipated approval of UGN-102 and the timing thereof; the potential for UGN-102 to introduce a new non-surgical treatment option for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel® technology to improve therapeutic profiles of existing drugs and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options; and other statements that are not historical fact. Words such as “anticipate,” “believe,” “could,” “if,” “intend,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the anticipated advantages of UGN-103 and UGN-104 have not yet been demonstrated or achieved, as applicable, and it is possible one or more of these anticipated advantages will not be realized; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of initiating and progressing clinical trials, reporting data and initiating product launches; the ability to obtain regulatory approval within the timeframe expected, or at all; even if an NDA for UGN-102 is accepted for filing by the FDA, there is no guarantee that such NDA will be given priority review or that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the ability to maintain regulatory approval; the ability to obtain and maintain adequate intellectual property rights and adequately protect and enforce such rights; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and UroGen’s financial condition and need for additional capital in the future. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 13, 2024 (which is available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240916912176/en/
INVESTORS:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@urogen.com
609-460-3588 ext. 1093
MEDIA:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
FAQ
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