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UroGen Pharma Announces Early Stage Feasibility Agreement with Janssen

April 23, 2019

NEW YORK--(BUSINESS WIRE)--Apr 23, 2019--UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, today announced that it has entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.

“We are excited to enter into this agreement with Janssen, an industry leader with a history of developing transformative therapies,” said Liz Barrett, President and Chief Executive Officer of UroGen. “We maintain a strong commitment to bringing innovative treatments to patients in areas of unmet need.”

About UroGen Pharma Ltd.

UroGen Pharma Ltd. (Nasdaq:URGN) is a clinical-stage biopharmaceutical company developing advanced non-surgical treatments to address unmet needs in the field of urology, with a focus on uro-oncology. UroGen has developed RTGel™ reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve 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. UroGen’s lead investigational candidates, UGN-101 (mitomycin gel) for instillation, and UGN-102 (mitomycin gel) for intravesical instillation, are designed to potentially ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer and low-grade non-muscle invasive bladder cancer, respectively. UroGen is headquartered in New York, NY with operations in Los Angeles, CA and Israel.

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 plans to conduct an early stage feasibility evaluation, the potential of UGN-101 for LG UTUC, the potential of UroGen’s proprietary RTGel™ technology platform to improve therapeutic profiles of existing drugs, and the potential of UGN-102 for LG NMIBC, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials, including the Olympus pivotal Phase 3 trial and potential safety and other complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen Pharma’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; and UroGen Pharma’s ability to attract or retain key management, members of the board of directors and personnel. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen Pharma’s Form 10-K filed with the SEC on February 28, 2019 and other filings that UroGen Pharma makes with the SEC from time to time (which are available at http://www.sec.gov ), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen Pharma’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 Pharma as of the date of this release.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190423005292/en/

CONTACT: Media:

UROGEN:

Kate Bechtold

Director, Corporate Communications & Investor Relations

Kate.Bechtold@urogen.com

914-552-0456

KEYWORD: UNITED STATES NORTH AMERICA NEW YORK

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: UroGen Pharma Ltd.

Copyright Business Wire 2019.

PUB: 04/23/2019 08:00 AM/DISC: 04/23/2019 08:01 AM

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