BURLINGTON, Mass., May 26, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announces that yesterday it received written responses
from the U.S. Food & Drug Administration (FDA) to questions the company had submitted in advance of a pre-NDA meeting regarding
Flexion’s lead product candidate, Zilretta (also known as FX006). The FDA clearly indicates in its responses that the safety and
efficacy data from the registration program for Zilretta are “acceptable to support filing of an NDA submission.” Based on this
positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official
meeting minutes.
Michael Clayman, M.D., President and Chief Executive Officer of Flexion, stated, “The endorsement from the FDA for the Zilretta
NDA submission represents a major milestone in the development of this drug candidate and brings us one step closer to making it
available to the many millions of knee osteoarthritis (OA) patients who lack good pain-relief options. We intend to submit the NDA
in the fourth quarter of this year.”
About Zilretta
Zilretta is being investigated as the first intra-articular sustained-release, non-opioid treatment for patients with moderate
to severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting
corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude
and prolong the duration of pain relief.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have
been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with
immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain
relief.
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 analgesic therapy for the millions of U.S. patients who receive IA injections
for knee OA 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; our ongoing development of Zilretta; our interpretation of the data and results from our
Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to
commercialize Zilretta and its market potential; and the potential therapeutic and other benefits of Zilretta, 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; the fact that results of past clinical trials may not be predictive of subsequent trials; 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 commencement, enrollment and completion dates and regulatory
filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing 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 key employees, 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.
Investor Contact David Carey Lazar Partners LTD T: 212-867-1768 dcarey@lazarpartners.com Media Contact Mariann Caprino TogoRun T: 917.242.1087 M.Caprino@togorun.com Corporate Contact Fred Driscoll Chief Financial Officer Flexion Therapeutics, Inc. T: 781-305-7763 fdriscoll@flexiontherapeutics.com
