UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers
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Insights
The licensing agreement between UroGen Pharma and medac GmbH to develop UGN-103, a mitomycin-based formulation for urothelial cancers, signifies a strategic move in the biotech industry. Mitomycin is a chemotherapy drug that has been used in the treatment of various cancers and its combination with UroGen's proprietary RTGel® technology could offer a novel non-surgical treatment option for patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The focus on this specific patient population addresses a current treatment gap, as many patients are either ineligible for surgery or seek alternatives to avoid its risks and complications.
From a research perspective, the initiation of a Phase 3 study is a critical step in the drug development process, representing a transition from early clinical testing to large-scale testing for efficacy and safety. The anticipated benefits related to production, cost, supply and product convenience are significant, as they could lead to better patient adherence and potentially lower healthcare costs. However, the actual impact on the market will depend on the clinical trial results, regulatory approval and the competitive landscape at the time of potential launch.
The announcement of a licensing agreement for a next-generation cancer treatment could have a positive impact on UroGen Pharma's stock performance, particularly if investor sentiment is buoyed by the potential for extended intellectual property protection until December 2041. This extended protection timeline, resulting from the combination of medac's intellectual property and UroGen's pending U.S. patent applications, could offer a competitive advantage and long-term revenue potential for UroGen Pharma.
Investors will likely monitor the progress of UGN-103 closely, especially as the Phase 3 study approaches. The development costs, potential market size and pricing strategy will be key factors in determining the financial impact of UGN-103 on UroGen's bottom line. It's important to note that while the licensing agreement and the planned study are positive steps, the actual financial impact will only materialize if the product receives FDA approval and successfully penetrates the market.
The strategic alliance between UroGen Pharma and medac GmbH is poised to potentially disrupt the urothelial cancer treatment market. Current treatments for LG-IR-NMIBC often involve surgery and intravesical therapy, which can be invasive and have limitations. A next-generation formulation like UGN-103 could meet an unmet need by providing a non-surgical treatment option that improves convenience and reduces treatment burden for patients.
Market adoption of UGN-103, should it be approved, will depend on several factors, including efficacy, safety profile, ease of use and cost-effectiveness compared to existing treatments. Additionally, the ability to secure favorable reimbursement from insurance providers will be crucial for widespread patient access. The potential market size for UGN-103 could be substantial, given the prevalence of bladder cancer and the demand for less invasive treatment options.
UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow the anticipated
"The strategic alliance with medac fortifies our commitment to continuously innovate novel, non-surgical treatments for patients with urothelial cancers, including LG-IR-NMIBC,” said Liz Barrett, President and CEO of UroGen. "The 80 mg formulation of mitomycin from medac is specifically designed to be mixed with our RTGel® technology, which may provide advantages for patients looking for non-surgical treatments for urothelial cancer. With medac's intellectual property protection for this next-generation mitomycin formulation lasting until June 2035 and our pending
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. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024 and an FDA decision in 2025.
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 GmbH
medac is a privately-owned German pharmaceutical company with sites in Wedel and Tornesch. medac’s medicinal products are used worldwide to help doctors and patients manage acute and chronic diseases in the fields of oncology and haematology, urology, and autoimmune diseases. medac also develops and distributes specialist diagnostic systems. Since 1970, medac has been committed to its approach of uniting therapeutic and diagnostic products under one roof. Further information on the company and its products can be found online at www.medac.de.
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: the anticipated approval and launch of UGN-102; the timing for the planned Phase 3 trial of UGN-103 and the potential approval of UGN-103; the potential advantages of UGN-103; anticipated intellectual property protection; the anticipated submission of an NDA for UGN-102 and the timing thereof; the anticipated timing for an FDA decision on the UGN-102 NDA; the potential for UGN-102 to introduce a new non-surgical treatment option for LG-IR-NMIBC; and 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. Words such as “anticipate,” “believe,” “could,” “expect,” “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: preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials, reporting data and initiating product launches; the ability to obtain regulatory approval within the timeframe expected, or at all; the findings from the durability of response endpoint from the ENVISION Phase 3 study may not be positive, and in such event, our NDA pathway could be negatively impacted; even if the durability of response endpoint data from the ENVISION Phase 3 study are positive, there is no guarantee that our NDA for UGN-102 will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; UroGen’s pending patent applications may not be successful and in such event the duration of our intellectual property protection would be more limited; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property; the size and growth of the market(s) for our product and product candidates and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; UroGen’s ability to attract or retain key management, members of the board of directors and personnel; UroGen’s RTGel technology may not perform as expected; 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 September 30, 2023, filed with the SEC on November 14, 2023 (which is available at http://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.
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INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@urogen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
FAQ
What is the licensing agreement announced by UroGen Pharma Ltd. (URGN)?
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