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press release

March 23, 2020, 9:23 a.m. EDT

UroGen Pharma Promotes Key Personnel Focused on Commercial Operations and Expanded Clinical Development

Experienced Leadership Team with Established Track Record Prepares for Transition to a Commercial Stage Organization

UroGen Pharma Ltd. /zigman2/quotes/202929873/composite URGN +0.05% a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced promotions for key members of the Executive Leadership Team. These appointments will better position the Company for its next growth phase with the anticipated approval and launch of its first product candidate, UGN-101 (mitomycin gel) for instillation, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). In December 2019, the U.S. Food and Drug Administration accepted for filing and granted priority review for the Company’s UGN-101 application and assigned a Prescription Drug User Fee Act (PDUFA) action date of April 18, 2020.

Effective April 1, 2020, the following individuals will be promoted to the following roles:

  • Jeff Bova, Chief Commercial Officer

  • Marina Konorty, PhD, Executive Vice President, Research & Development and Technical Operations

  • James Ottinger, RPh, Executive Vice President, Regulatory Affairs and Quality

  • Elyse Seltzer, MD, Chief Development Officer

“I am delighted to announce the promotions of these outstanding colleagues and to see firsthand how they will continue to help transform the Company with their expanded responsibilities. UroGen’s accomplishments to date have been a direct result of their tireless efforts, and I look forward to continuing to work with this talented and experienced team as we together embark on the most transformational time for our company,” said Liz Barrett, President and Chief Executive Officer of UroGen. “We are rapidly approaching potential approval and commercialization of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer. With this team, I’m confident in our ability to deliver on the promise of our RTGel™ platform and advance our pipeline of product candidates for patients in areas of unmet need.”

Jeff Bova, Chief Commercial Officer

Mr. Bova joined UroGen in 2017 and most recently served as UroGen’s Senior Vice President of Commercial. He is an experienced pharmaceutical industry executive with extensive leadership experience across key commercial functional areas, including national sales, marketing, and managed care. Prior to UroGen, he spent 20 years at Bayer Healthcare, holding multiple senior-level leadership positions of increasing responsibility. Most recently at Bayer, Mr. Bova served as Vice President of Oncology Sales, where he led a field sales force of more than 200 in marketing well-known brands such as Xofigo®, Stivarga®, and Nexavar®. He also previously served as Vice President of Marketing for Bayer’s prostate cancer franchise where he designed, developed, and led the highly successful launch of Xofigo®. Mr. Bova holds a Master’s Degree in business administration from Xavier University and a Bachelor of Science in finance and marketing from the University of Cincinnati.

Marina Konorty, PhD, Executive Vice President, Research & Development and Technical Operations

Dr. Konorty joined UroGen as Chief Chemist in 2011 and most recently served as UroGen’s Senior Vice President of Research and Development and Head of Israeli Operations. In her role as Chief Chemist, Dr. Konorty was responsible for development of the RTGel™ reverse-thermal hydrogel technology platform, including optimization of its delivery properties and verifying its suitability as a drug carrier in humans. She has subsequently led development of the manufacturing processes and specifications associated with RTGel™-formulated drug products for the UroGen clinical development pipeline. Prior to UroGen, Dr. Konorty served as Project Manager at TransPharma Medical, a medical device and drug delivery company. A published author with multiple patents, she holds a PhD in organic chemistry from the Weizmann Institute of Science and a Master of Science and Bachelor of Science in chemical engineering from the Technion Institute of Technology.

James Ottinger, RPh, Executive Vice President, Regulatory Affairs and Quality

Mr. Ottinger joined UroGen in 2017 and most recently served as Senior Vice President of Regulatory Affairs, and has been directly responsible for guiding the regulatory pathway for UGN-101’s potential U.S. FDA approval. He is an experienced pharmaceutical industry executive with more than 30 years of strategic regulatory experience, having supported the successful development, approval, and marketing of a number of new drugs throughout his career. Prior to joining UroGen, Mr. Ottinger served as Senior Vice President of Global Regulatory Affairs at Teva Pharmaceutical Industries, Ltd., where he was responsible for global regulatory oversight of Teva’s portfolio of branded, generic, and over-the-counter products. Earlier in his career, Mr. Ottinger led both regulatory affairs and quality assurance with Premier Research Group Limited, and regulatory positions of increasing responsibility at Wyeth Research (acquired by Pfizer, Inc.). He holds a Bachelor of Science in pharmacy from the Temple University School of Pharmacy and is a registered pharmacist in the State of Pennsylvania.

Elyse Seltzer, MD, Chief Development Officer

Dr. Seltzer joined UroGen in 2017 and most recently served as UroGen’s Senior Vice President of Clinical Development. She brings a strong track record in clinical development within the pharmaceutical industry. Prior to joining UroGen, Dr. Seltzer served as Chief Medical Officer of Nabriva Therapeutics, where she was a key member of the management team that took the company public, and was responsible for the clinical and regulatory strategy and implementation of the company’s clinical development of Xenleta™ (lefamulin) for community acquired pneumonia. Dr. Seltzer joined Nabriva from GlaxoSmithKline (GSK), where she was Vice President of Global Clinical Sciences and Operations. Prior to joining GSK, Dr. Seltzer served as Chief Medical Officer at Tengion, a regenerative medicine company, where she established and built the company’s clinical organization. Dr. Seltzer previously held senior clinical development roles at Centocor and Vicuron and began her industry career at SmithKline Beecham (now GSK). Before joining the pharmaceutical industry, she practiced consultative Infectious Diseases and HIV care. Dr. Seltzer holds an MD from the New York University School of Medicine, completed her Internal Medicine training at the University of Pennsylvania Medical Center and her Infectious Diseases Training at Yale New Haven Hospital.

As UroGen positions itself for the next stage of growth, Stephen Mullennix, who has served as Chief Operating Officer, will be departing the company to pursue other opportunities. Mr. Mullennix has played an important role building the foundation for operational and financial efficiencies as the Company prepared for commercialization. Mr. Mullennix’s responsibilities will be transitioned to Mr. Bova, Dr. Konorty, and Mr. Ottinger, in their expanded roles.

About UroGen Pharma Ltd.

UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases 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 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 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 Princeton, NJ with operations in New York, NY and Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.

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: the potential for UGN-101 to be approved and the timing thereof as a treatment option for LG UTUC; the expected readiness of UroGen for a potential commercial launch of UGN-101; and the potential of UroGen’s proprietary RTGel™ technology platform to improve therapeutic profiles of existing drugs. These and other statements above 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 Phase 3 trial and potential safety and other complications thereof; the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with achieving commercial readiness for the launch of a new product; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGen’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’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’s Form 10-K filed with the SEC on March 2, 2020, and other filings that UroGen 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’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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200323005114/en/

SOURCE: UroGen Pharma Ltd.

INVESTOR CONTACT:
Kate Bechtold
Senior Director, Investor Relations
Kate.Bechtold@urogen.com
914-552-0456 MEDIA CONTACT:
Eric Van Zanten
Senior Director, Communications
Eric.VanZanten@urogen.com
610-529-6219

Copyright Business Wire 2020

/zigman2/quotes/202929873/composite
US : U.S.: Nasdaq
$ 19.31
+0.01 +0.05%
Volume: 101,028
Sept. 25, 2020 4:00p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$425.28 million
Rev. per Employee
$16,114
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