PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers..

新泽西州普林斯顿市（商业新闻短讯）--UroGen Pharma Ltd.（纳斯达克：URGN）是一家致力于开发和商业化治疗尿路上皮癌和特殊癌症的新型解决方案的生物技术公司，今天宣布与medac GmbH签订许可协议，开发下一代基于丝裂霉素的尿路上皮癌新型制剂。。

UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow the anticipated U.S. Food and Drug Administration approval and launch of UGN-102. UGN-103 is expected to provide advantages related to production, cost, supply, and product convenience if approved.

UGN-103是UroGen的RTGel®技术与medac的许可丝裂霉素相结合的下一代制剂，计划遵循预期的美国食品和药物管理局批准和推出UGN-102。如果获得批准，UGN-103有望在生产、成本、供应和产品便利性方面提供优势。

UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC..

UroGen计划于2024年启动一项3期研究，以探索UGN-103在LG-IR-NMIBC中的安全性和有效性。。

'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.

UroGen总裁兼首席执行官利兹·巴雷特（LizBarrett）说：“与medac的战略联盟强化了我们对尿路上皮癌患者（包括LG-IR-NMIBC）不断创新新型非手术治疗的承诺。”medac的80 mg丝裂霉素制剂专门设计用于与我们的RTGel®技术混合，这可能为寻求尿路上皮癌非手术治疗的患者提供优势。

With medac's intellectual property protection for this next-generation mitomycin formulation lasting until June 2035 and our pending U.S. patent applications, we foresee potential intellectual property protection until December 2041.'.

随着medac对这种下一代丝裂霉素制剂的知识产权保护持续到2035年6月，以及我们正在申请的美国专利申请，我们预计潜在的知识产权保护将持续到2041年12月。”。

About UGN-102

关于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.

用于膀胱内溶液的UGN-102（丝裂霉素）是丝裂霉素的创新药物制剂，目前处于用于治疗LG-IR-NMIBC的3期开发中。UGN-102利用UroGen专有的RTGel®技术（一种基于水凝胶的缓释制剂）设计用于使膀胱组织更长时间暴露于丝裂霉素，从而能够通过非手术手段治疗肿瘤。

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..

UGN-102在门诊使用标准导尿管输送给患者。假设ENVISION 3期研究的反应终点的持久性得到了积极的发现，UroGen预计将于2024年提交UGN-102的新药申请（NDA），并于2025年提交FDA的决定。。

About UroGen Pharma Ltd.

关于UroGen制药有限公司

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是一家生物技术公司，致力于开发和商业化治疗尿路上皮癌和特殊癌症的创新解决方案，因为患者应该得到更好的选择。UroGen开发了RTGel®反向热水凝胶，这是一种专有的缓释水凝胶平台技术，有可能改善现有药物的治疗效果。

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的缓释技术旨在使泌尿道组织更长时间暴露于药物，使局部治疗成为潜在的更有效的治疗选择。我们的第一个治疗LG-UTUC的产品和用于低级别非肌肉浸润性膀胱癌患者膀胱内溶液的研究性治疗UGN-102（丝裂霉素）旨在通过非手术手段消融肿瘤。

UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X (Twitter), @UroGenPharma..

UroGen总部位于新泽西州普林斯顿，在以色列运营。访问www.urogen.com了解更多信息，或在X（推特），@UroGenPharma上关注我们。。

About medac GmbH

关于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.

medac是一家私人拥有的德国制药公司，在Wedel和Tornesch设有办事处。medac的医药产品在全球范围内用于帮助医生和患者管理肿瘤学和血液学、泌尿学和自身免疫性疾病领域的急慢性疾病。medac还开发和分发专家诊断系统。

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..

自1970年以来，medac一直致力于将治疗和诊断产品结合在一起。有关该公司及其产品的更多信息，请访问www.medac.de。。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的前瞻性声明，包括但不限于以下声明：UGN-102的预期批准和发布；计划的UGN-103第三阶段试验的时间安排以及UGN-103的潜在批准；UGN-103的潜在优势；预期的知识产权保护；UGN-102 NDA的预期提交及其时间安排；FDA对UGN-102 NDA作出决定的预期时间；UGN-102为LG-IR-NMIBC引入新的非手术治疗选择的潜力；以及UroGen专有的RTGel®技术改善现有药物治疗效果的潜力，以及UroGen的缓释技术，与其他治疗方案相比，局部给药可能更有效。

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 endpo.

诸如“预期”、“相信”、“可以”、“期望”、“计划”、“潜力”、“意愿”等词语，或其他表达未来事件或结果不确定性的词语，以识别这些前瞻性陈述。这些报表受到许多风险、不确定性和假设的影响，包括但不限于：初步结果可能不表明未来可能观察到的结果；临床试验的时机和成功以及潜在的安全性和其他并发症；可能影响临床试验进展，报告数据和启动产品发布时间的不可预见的延迟；能够在预期的时间范围内或根本无法获得监管部门的批准；ENVISION第3阶段研究的反应终点持久性的发现可能不是积极的，在这种情况下，我们的NDA途径可能会受到负面影响；即使响应endpo的耐久性。