BURLINGTON, Mass., April 07, 2017 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that
Yamo Deniz, MD, has been named Chief Medical Officer (CMO). This appointment strengthens the company’s leadership with an industry
veteran who brings extensive experience leading medical and clinical development teams at major biotechnology and pharmaceutical
companies.
With the addition of Dr. Deniz, Neil Bodick, MD, PhD, co-founder of Flexion, will transition from his position as
CMO and assume the role of Chief Scientific Officer. In his new capacity, Dr. Bodick will be responsible for building Flexion’s
pipeline of new drug candidates and leading discovery research activities including the assessment of external opportunities and
new applications for the company’s proprietary formulation technologies.
Dr. Deniz is an allergist and immunologist by training, and prior to joining Flexion, he served as Vice President
and Global Head of Medical for Rare Diseases at Sanofi-Genzyme. Previously, he held positions as Chief Medical Officer, Global Head
of Medical & Pharmacovigilance and as Vice President and Global Head of Development at GE Healthcare Medical Diagnostics. Dr. Deniz
also held numerous senior clinical development and leadership positions of increasing responsibilities in the Respiratory and
Inflammation groups at Genentech and Roche. Dr. Deniz received his medical degree from the University of Massachusetts Medical
School. He completed his residency at Long Island Jewish Medical Center and fellowship at Duke University Medical Center.
“With his demonstrated track record of clinical development and medical affairs, Dr. Deniz is a superb addition to
Flexion’s management team as we prepare for the potential approval and commercialization of Zilretta™, also known as FX006,” said
Michael Clayman, MD, President and Chief Executive Officer of Flexion. “His extensive pharmaceutical R&D background will be
invaluable to us as we expand Flexion into a fully integrated pharmaceutical company. In addition to his deep industry knowledge,
Dr. Deniz’s team-based approach and entrepreneurial spirit exemplify Flexion’s core values and make him an excellent fit for our
company culture.”
In February 2017, Flexion announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug
Application for Zilretta in osteoarthritis (OA) of the knee. Under the Prescription Drug User Fee Act (PDUFA), the agency has
established a user fee goal date of October 6, 2017.
About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local
therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company's lead product candidate,
Zilretta, is being investigated for its potential to provide improved analgesia for the millions of U.S. patients who receive
intra-articular injections for OA-related knee pain annually.
Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to,
statements relating to the future of Flexion and its potential growth; and the expected benefits of Flexion’s hiring of Dr. Deniz,
are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the
date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks
associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and
effective for use as human therapeutics; whether we are able to retain key employees, including Dr. Deniz; our reliance on third
parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory
approval; our ability to meet anticipated clinical trial enrollment and completion timelines; the fact that we will require
additional capital, including to fully commercialize Zilretta or any other product candidates, and may be unable to obtain such
additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our
intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory
developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk
that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of
Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully
commercialized, including as a result of the FDA's or other regulatory authorities' decisions regarding labeling and other matters
that could affect its availability or commercial potential; risks related to markets, economic conditions, health care reform,
prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange
Commission (SEC), including under the heading "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings
with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we
undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the
forward-looking statements contained in this press release.
Corporate Contact: Scott Young Sr. Director, Corporate Communications & Investor Relations Flexion Therapeutics, Inc. T: 781-305-7194 syoung@flexiontherapeutics.com Media Contact: Danielle Lewis Lazar Partners T: 212-867-1768 flexionpr@lazarpartners.com Investor Contact: David Carey Lazar Partners T: 212-867-1768 dcarey@lazarpartners.com
