Flexion Therapeutics Announces Appointment of Mark Stejbach to its Board of Directors
September 14 2016 - 8:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today the
appointment of Mark Stejbach, Senior Vice President and Chief
Commercial Officer at Alkermes plc, to its Board of Directors as
the company prepares for commercialization of its drug candidate
Zilretta™ (also known as FX006), a potential treatment for patients
with moderate to severe knee osteoarthritis (OA) pain. Flexion
plans to submit a new drug application (NDA) in the fourth quarter
of 2016 to the U.S. Food and Drug Administration (FDA).
Michael Clayman, MD, President and Chief Executive Officer of
Flexion, stated, “We are delighted to be bringing Mark’s
considerable commercial experience and know-how to our Board of
Directors. We are confident that his strategic expertise and his
deep and current knowledge of sales and marketing will complement
the backgrounds of the existing Board members and will contribute
insight and perspective to our recently expanded internal
commercial capabilities. All of this is vitally important as we
prepare Zilretta for potential approval and commercial launch,
which we anticipate to happen in 2017.”
Mr. Stejbach has more than 25 years of leadership experience in
biotech and commercial marketing, sales, managed care, and finance.
As Chief Commercial Officer at Alkermes, Mr. Stejbach is
responsible for marketing, sales, managed care and trade channels,
commercial analytics, patient services, new product planning and
commercial strategy. Previously, he served at Tengion, Inc. from
2008 to 2012, most recently as Chief Commercial Officer. He
previously held senior positions at Merck & Co. and Biogen
Idec. Mr. Stejbach received his MBA from the University of
Pennsylvania and a Bachelor of Science in mathematics from Virginia
Tech.
“I’m honored to join the Flexion Therapeutics Board of Directors
as the company prepares to submit an NDA for its drug candidate,
Zilretta, to the FDA,” said Mr. Stejbach. “If approved for
commercialization, Zilretta would be an important drug in the
armamentarium of physicians who treat patients with pain associated
with knee OA.”
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 plans for, and the expected
timing of, our Zilretta NDA submission with the FDA; our plans to
commercialize Zilretta, including the expected timing for approval
and commercial launch 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;
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
regulatory filing, approval, and commercial launch 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
Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com
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