Flexion Therapeutics Announces Two Key Corporate Appointments
September 12 2016 - 8:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it
has made two key appointments to its leadership team: Carolyn Beaty
Scimemi, Esq., an experienced compliance and legal professional, as
Chief Compliance Officer, and Adam Muzikant, Ph.D., a veteran
biotechnology deal negotiator and strategist, as Vice President,
Business Development.
Ms. Scimemi and Dr. Muzikant join the Flexion leadership team as
the company prepares to submit a planned new drug application (NDA)
in the fourth quarter of 2016 to the U.S. Food and Drug
Administration (FDA) for its drug candidate Zilretta™ (also known
as FX006), a potential treatment for patients with moderate to
severe knee osteoarthritis (OA) pain.
Michael Clayman, MD, President and Chief Executive Officer of
Flexion, stated, “We are delighted to add Carolyn and Adam to our
leadership roster based upon their depth of experience and
backgrounds in their respective fields. Carolyn will play a
critical role as we work through the legal and compliance areas
crucial to the approval and launch of Zilretta, and as we create a
robust culture of compliance. In addition, we will benefit greatly
from Adam’s leadership as we forge partnerships and continue to
build our pipeline.”
Ms. Scimemi has more than a decade of experience working with
legal and contractual matters for publicly traded biopharmaceutical
companies in both pre-approval and in commercial stages of product
development. She joined Dyax in 2009 and most recently served as
Vice President, Associate General Counsel & Chief Compliance
Officer. Previously, she was Associate Director of Legal Affairs
and Compliance for Oscient Pharmaceuticals in Waltham, MA, an
associate attorney at Palmer and Dodge LLP in Boston, and a
contracts administrator at the Massachusetts Institute of
Technology. She earned her JD and Bachelor’s of Science degrees
from Suffolk Law School in Boston.
Dr. Muzikant joins Flexion with 18 years of hands-on leadership
experience in biotechnology and specialty pharmaceuticals
companies, and consulting firms. Most recently, he was Vice
President, Business Development at Synta Pharmaceuticals in
Lexington, Mass., where he led the strategic transaction process
culminating in a merger with Madrigal Pharmaceuticals. Prior to
Synta, Dr. Muzikant held business development leadership positions
at AMAG Pharmaceuticals, Inotek Pharmaceuticals, EPIX
Pharmaceuticals, and Predix Pharmaceuticals, and also performed
transaction/strategic advisory work for biotechnology and
pharmaceutical clients with Locust Walk Partners. Prior to moving
into business development, Dr. Muzikant led an anti-arrhythmia drug
discovery program at Predix targeting ion channels. He received his
Ph.D. in biomedical engineering from Duke University, and a
Bachelor’s degree in bioengineering from the University of
California, San Diego.
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; 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 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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