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 that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S.

新泽西州普林斯顿——（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，它已向美国特拉华州地方法院提起诉讼，指控Teva Pharmaceuticals，Inc.，Teva Pharmaceuticals USA，Inc。和Teva Pharmaceutical Industries，Ltd.侵犯美国。

Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”). Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution.

专利号9040074（“074专利”）和9950069（“069专利”）。这两项专利均列在美国食品和药物管理局（“FDA”）批准的药物产品中，并对用于肾盂肾溶液的JELMYTO®（丝裂霉素）进行了治疗等效性评估（通常称为橙皮书）。

JELMYTO® is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology..

JELMYTO®适用于治疗成人低度上尿路上皮癌（“LG-UTUC”），并利用UroGen的RTGel®反向热水凝胶，这是一种专有的缓释水凝胶平台技术。。

“UroGen pioneered a significant breakthrough and remains at the forefront of transforming urothelial cancer treatment,” said Liz Barrett, President and CEO, UroGen. “UroGen has full confidence in the strength of its patents and plans to vigorously defend our intellectual property rights.”

UroGen总裁兼首席执行官利兹·巴雷特（LizBarrett）表示：“UroGen开创了一项重大突破，仍然处于改变尿路上皮癌治疗的前沿。”。“UroGen对其专利的实力充满信心，并计划大力捍卫我们的知识产权。”

The lawsuit follows an Abbreviated New Drug Application filed by Teva Pharmaceuticals, Inc., which seeks authorization from the FDA to manufacture, use or sell a generic version of mitomycin for pyelocalyceal solution, 40 mg/vial in the United States before the expiry of the ’074 and ’069 patents.

这起诉讼之前，Teva Pharmaceuticals，Inc.提交了一份简短的新药申请，该申请寻求FDA的授权，在074年和069年专利到期之前，在美国制造、使用或销售用于肾盂肾溶液的丝裂霉素仿制药，每瓶40毫克。

About JELMYTO

关于杰尔米托

JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy.

用于肾盂肾溶液的JELMYTO®（丝裂霉素）是一种含有丝裂霉素的反向热凝胶，每毫升凝胶含有4毫克丝裂霉素，用于治疗LG-UTUC成年患者。建议对被认为适合保留肾脏治疗的患者进行活检证实的LG-UTUC的初步治疗。

JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube.

JELMYTO在冷却时是粘性液体，在体温下变成半固体凝胶。该药物在滴注后4至6小时内缓慢溶解，并通过正常的尿流和排尿从泌尿道中排出。它被批准通过输尿管导管逆行给药或通过肾造口管顺行给药。

The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow..

输送系统允许初始液体涂覆并符合上尿路解剖结构。最终的半固体凝胶允许化学消融疗法在收集系统中保留四到六个小时，而不会立即被尿液稀释或冲走。。

About Upper Tract Urothelial Cancer (UTUC)

关于上尿路上皮癌（UTUC）

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 - 7,000 new or recurrent low-grade UTUC patients annually.

尿路上皮癌是全球第九大常见癌症，也是美国男性第八大致命肿瘤。原发性尿路上皮癌中有5%至10%起源于输尿管或肾盂，统称为上尿路上皮癌（UTUC）。在美国，每年约有6000至7000名新发或复发的低度UTUC患者。

Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse..

大多数病例被诊断为70岁以上的患者，这些老年患者经常面临合并症。UTUC的治疗选择有限，最常见的是内镜手术或肾输尿管切除术（切除整个肾脏和输尿管）。这些治疗可能导致高复发率。。

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 low-grade upper tract urothelial cancer 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。我们的第一个治疗低度上尿路上皮癌的产品和用于低度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。。

APPROVED USE FOR JELMYTO

批准用于JELMYTO

JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

JELMYTO®是一种处方药，用于治疗患有上尿路衬里癌症（包括肾脏）的成年人，称为低度上尿路尿路上皮癌（LG-UTUC）。

IMPORTANT SAFETY INFORMATION

重要安全信息

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

如果你的膀胱或上尿路有洞或撕裂（穿孔），你不应该接受杰米托。

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

在接受杰尔米托之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

怀孕或计划怀孕。杰尔米托会伤害你的未出生婴儿。在用杰米托治疗期间，你不应该怀孕。如果你怀孕了，或者在服用杰米托期间认为自己可能怀孕了，请立即告诉你的医疗保健提供者。能够怀孕的女性：在使用杰米托治疗期间和最后一剂后6个月内，应使用有效的节育（避孕）。

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose..

接受JELMYTO治疗的男性：如果你有一位能够怀孕的女性伴侣，你应该在使用JELMYTO治疗期间以及最后一剂后3个月内使用有效的避孕措施。。

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.

正在母乳喂养或计划母乳喂养。不知道杰米托是否会进入你的母乳。在用JELMYTO治疗期间和最后一次给药后1周内不要母乳喂养。

Tell your healthcare provider if you take water pills (diuretic).

如果你服用水丸（利尿剂），请告诉你的医疗保健提供者。

How will I receive JELMYTO?

我将如何接收杰尔米托？

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.

你的医疗保健提供者会告诉你在每次治疗前服用一种名为碳酸氢钠的药物。

You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

您将每周1次从您的医疗保健提供者处获得JELMYTO剂量，持续6周。重要的是，您必须根据医疗保健提供者的说明接受所有6剂杰米托。如果您错过任何预约，请尽快致电您的医疗保健提供者，重新安排您的预约。

Your healthcare provider may recommend up to an additional 11 monthly doses..

您的医疗保健提供者可能会建议每月增加11剂。。

JELMYTO is given to your kidney through a tube called a catheter.

杰尔米托是通过一种叫做导管的管子送入肾脏的。

During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

在使用JELMYTO治疗期间，您的医疗保健提供者可能会告诉您服用其他药物或改变您目前的药物服用方式。

After receiving JELMYTO:

收到JELMYTO后：

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.

杰尔米托可能会导致你的尿液颜色从紫色变为蓝色。避免皮肤和尿液接触至少6小时。

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

要小便，男性和女性应该坐在马桶上，用完后冲洗几次。上完卫生间后，用肥皂和水好好洗手、大腿内侧和生殖器部位。

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

与尿液接触的衣物应立即清洗，并与其他衣物分开清洗。

JELMYTO may cause serious side effects, including:

杰尔米托可能会引起严重的副作用，包括：

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain.

将尿液从肾脏输送到膀胱的管子肿胀和变窄（输尿管梗阻）。如果您出现肿胀和狭窄，并且为了保护肾脏免受损害，您的医疗保健提供者可能会建议在输尿管中放置一个小塑料管（支架），以帮助肾脏引流。

Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO..

如果您在使用杰米托治疗期间出现侧面疼痛或发烧，请立即告知您的医疗保健提供者。。

Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO..

骨髓问题。JELMYTO会影响你的骨髓，并会导致你的白细胞、红细胞和血小板计数下降。您的医疗保健提供者将在每次治疗前进行血液检查，以检查您在使用杰米托治疗期间的血细胞计数。如果您在使用JELMYTO治疗期间出现骨髓问题，您的医疗保健提供者可能需要暂时或永久停止JELMYTO。。

The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

杰米托最常见的副作用包括：尿路感染、尿中有血、副作用、恶心、排尿困难、肾脏问题、呕吐、疲倦、胃（腹部）疼痛。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch或致电1-800-fda-1088。您也可以致电1-855-987-6436向UroGen Pharma报告副作用。

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

有关更多信息，请参阅JELMYTO完整的处方信息，包括患者信息。

Forward-Looking Statements

前瞻性声明

This statement contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential for UroGen to transform urothelial cancer treatments; the strength of UroGen’s patents and UroGen’s plans to vigorously defend its intellectual property rights; the patient population for UTUC; 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.

本声明包含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：尿原改变尿路上皮癌治疗的潜力；UroGen专利的实力以及UroGen大力捍卫其知识产权的计划；UTUC的患者人群；UroGen专有RTGel技术改善现有药物治疗效果的潜力；与其他治疗方案相比，UroGen的缓释技术使局部分娩可能更有效。

Words and phrases such as “anticipate,” “assume,” “believe,” “expected,” “if,” “indicate,” “look forward to,” “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: uncertainties related to whether UroGen’s patent-infringement lawsuit against Teva will be successful; the ability obtain and maintain adequate intellectual property rights and adequately protect and enforce such rights; the costs and outcome of legal proceedings to enforce such intellectual property rights, including the lawsuit against Teva; competition in UroGen’s industry, including the potential approval and introduction of generic or branded products that compete with UroGen’s product or product candidates; the ability to maintain regulatory approval; complications associated with commercialization activities; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the timing and success of clinical trials and potential safety and other complications ther.

诸如“预期”，“假设”，“相信”，“预期”，“如果”，“表明”，“期待”，“潜在”，“将”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。这些陈述受到许多风险、不确定性和假设的影响，包括但不限于：与UroGen对Teva的专利侵权诉讼是否成功有关的不确定性；能够获得和维护足够的知识产权，并充分保护和执行这些权利；执行此类知识产权的法律诉讼的成本和结果，包括针对Teva的诉讼；UroGen行业的竞争，包括可能批准和引入与UroGen产品或候选产品竞争的仿制药或品牌产品；保持监管批准的能力；与商业化活动相关的并发症；UroGen候选产品开发和商业化的范围、进展和扩展；临床试验的时机和成功以及潜在的安全性和其他并发症。