UroGen Pharma, Inc.
We are a biopharmaceutical company dedicated to building novel solutions that treat urothelial and specialty cancers. Our breakthrough therapy and innovative clinical pipeline aim to maximize the potential benefit of local delivery with our novel RTGel technology by bringing to patients transformative, nonsurgical approaches to challenging urothelial and specialty cancers—because we believe patients deserve better.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Nationally (across the country)
Welcome
Our drive to transform possibilities for patients fuels our bold approach.
How do we do better by patients? By striving to fundamentally change the way urothelial and specialty cancers are treated. Advances in urothelial cancers have historically been limited. For decades, patients have received the standard of care, which is often invasive or radical surgery. It’s because of these patients that UroGen exists. We believe patients deserve better.
UroGen is at the forefront of what we see as a transformative shift in urothelial and specialty cancers to treat patients by nonsurgical means. This paradigm shift was demonstrated with the launch of our first commercial product in 2020: JELMYTO® (mitomycin) for pyelocalyceal solution, the first and only FDA-approved nonsurgical treatment of its kind. JELMYTO uses our novel RTGel™ reverse-thermal hydrogel technology to offer an innovative treatment option for patients. Now, UroGen is building upon our innovations in delivery technology by exploring ways to harness the immune system to fight solid tumors in urothelial and specialty cancers.
As we move forward, UroGen will continue our focus on fundamentally changing the treatment paradigm from surgical care and disease management to noninvasive therapeutic options for some of the most devastating cancers. We invite you to learn about UroGen, our technological innovations, and our innovative pipeline, which reflects our vision of shaping the future of patient care.
Who Are We
We are driven to create lasting change for our patients
At UroGen, we're passionate about making a difference for patients with urothelial and specialty cancers—and we know true progress can only be made when diverse minds come together for this common goal.
What propels our momentum
Our Vision
We are pioneering new treatments to improve patient care.
Our Mission
We build novel solutions to treat urothelial and specialty cancers because patients deserve better options.
We value diversity and inclusion
Cancer doesn't discriminate. Since our founding, our commitment to supporting diverse populations starts within our company. We celebrate the differences in our team—race, ethnicity, gender identity, sexual orientation, age, religion, and disability—and strive to include perspectives from all walks of life. We believe our spectrum of backgrounds, identities, and abilities is what makes us stronger.
We believe in open dialogue
We're a tight-knit—and growing!—team of dreamers and doers who are passionate about making a difference. With over 150 employees, 40 of whom are based in Israel, we firmly believe every member of the UroGen team deserves to have their voice heard. We ensure transparency through an open-door policy and through internal organizations like the UroGen Culture Council, which brings together diverse perspectives from around our organization to build cross-departmental connection and collaboration.
We are powered by agility
Our people are go-getters who pivot at a moment's need and forge new paths when challenges arise. We pride ourselves in wearing multiple hats, pitching in whenever and wherever needed, to help advance treatment of urothelial and specialty cancers. As our company has grown from a small team in an office above a laundromat to a global network spanning continents, this nimble approach to innovation remains core to who we are.
About Us
Our Ethics and Compliance Program at UroGen
At Urogen, our mission is to build novel solutions to treat specialty cancers and urologic diseases because patients deserve better options. As important as our mission is how we conduct ourselves every day striving to achieve that mission on behalf of the patients that we collectively serve. That is why we at UroGen are committed to conducting all aspects of our business consistent with the highest ethical standards and applicable laws and regulations that govern our industry.
As part of this commitment, UroGen has adopted a Comprehensive Compliance Program (“CCP”) that is designed to prevent, detect, and resolve potential compliance issues. Our CCP is designed to effectuate the principles and framework set forth in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the by the U.S. Department of Health and Human Services Office of Inspector General in 2003 and the Pharmaceutical Research Manufacturers of America’s “Code on Interactions with Healthcare Professionals.”
Governance and Oversight
The Chief Compliance Officer at UroGen oversees all compliance activities. The Chief Compliance Officer is responsible for developing, operating, and monitoring our CCP. The Chief Compliance Officer reports directly to the President and Chief Executive Officer and has the authority to report to the Board of Directors. UroGen has established a Compliance & Business Integrity Committee, which consists of senior leaders across various business functions. The Chief Compliance Officer also provides quarterly reports to the Compliance Committee of the UroGen Board of Directors.
Documented Standards of Conduct
UroGen has established written standards of conduct. These policies and procedures are designed to ensure compliance with the requirements associated with federal healthcare programs and that our activities are appropriate, ethical, and consistent with applicable laws and regulations.
California Annual Spending Limit
Consistent with the requirements with California Health and Safety Code §§ 119400-119402, UroGen has established a specific annual aggregate dollar limit of $2,500 on the following items of value that UroGen may provide to healthcare professionals licensed in California: (a) meals provided in connection with informational presentations or scientific exchange; (b) educational items intended to enhance patient care (excluding items of minimal monetary value and/or of no independent value (i.e, printed advertising, reimbursement fact sheets, etc.)); and (c) items provided for the benefit of (and distribution to) patients or caregivers.
The annual limit does not include the following:
- Drug samples given to physicians and healthcare professionals;
- Financial support for continuing medical education programs or health educational scholarships;
- Payments for bona fide services, and any meals or expenses associated with the provision of such services;
- Materials that inform healthcare professionals about UroGen’s approved medicine or otherwise contain scientific and educational data
- Select medical devices that accompany sales of our prescription medicine that have no substantial independent value to healthcare professionals; and
- Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition.
Education and Training
UroGen provides its employees with periodic training and education to assist them in meeting the responsibility of conducting our business in an ethical manner and consistent with applicable laws and regulations. New employees will receive such instruction as part of their initial training and existing employees are expected to receive certain training on an annual basis.
Open Lines of Communication
UroGen is committed to fostering an environment where open communication regarding our policies, procedures, and business activities is encouraged. This includes the airing of concerns and reporting potential inappropriate activities. Any employee who has concerns about a particular activity is required to report such concerns. Employees may either report their concerns to their supervisors, senior leaders, or to any member of the compliance and legal team. UroGen also maintains a “Compliance Hotline” where employees may anonymously (where allowed by law) report potential inappropriate conduct or violations of our policies. Reports can be made to the UroGen Compliance Hotline by email at compliance@urogen.com or toll-free by telephone at 1‑844‑421‑1607.
The Compliance department (or its designee) will make a good-faith inquiry into any reported violation. UroGen expressly prohibits retaliation or retribution against any employee who reports or makes a good-faith effort to report suspected misconduct or inappropriate behavior.
Auditing and Monitoring
UroGen conducts auditing and monitoring activities to assess and evaluate compliance with the company’s policies and procedures as well as identify training policy or procedure needs. The Compliance Department will work with relevant internal and external experts and management as necessary to evaluate auditing and monitoring findings and ensure the implementation of any corrected action deemed necessary.
Corrective and Disciplinary Action
Compliance program violations result in corrective and/or disciplinary action. The corrective and/or disciplinary action may include (but is not limited to) termination or other discipline of the colleague(s) involved; retraining; or revisions to policies, procedures, training or any other aspect of the CCP to prevent reoccurrence of violations in the area.
UroGen Declaration of Compliance: California Health and Safety Code §§ 119400-119402
UroGen Pharma Inc. and UroGen Pharma Ltd. (collectively, “UroGen Pharma”) declares that, to the best of its knowledge and based on a good faith understanding of Health & Safety Code §§ 119400-119402, it has developed a Comprehensive Compliance Program (“CCP”) consistent with the requirements of California law. UroGen has tailored its CCP to the size, organization structure, and business operations of UroGen. UroGen will continually evaluate and update its CCP as necessary and appropriate as compliance and operational needs evolve. To the best of our knowledge and on a good-faith belief, UroGenis in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code sections 119400-119402. A description of our Comprehensive Compliance Program and a copy of this annual declaration are publicly available on our website and can be requested by emailing us at compliance@urogen.com or calling 609.467.4971, extension 1084.