Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that
Melissa Layman has been named Chief Commercial Officer (CCO). Ms.
Layman joins Flexion with more than 25 years of commercial
experience within the life science industry. Over the course of her
career she has held positions of increasing responsibility across
all areas of commercial operations including sales, marketing,
market access and analytics.
“I am genuinely delighted to welcome Melissa to Flexion during
one of the most exciting periods in Flexion’s history,” said
Michael Clayman, M.D., President and Chief Executive Officer of
Flexion. “She combines deep and broad commercial expertise with
important leadership experience and a strong track record of
success. I am confident that she will make a very real difference
for us and for patients on the journey to realizing the potential
of ZILRETTA®.”
"Flexion is an extraordinary company, and I am so proud and
excited to assume one of the premier executive opportunities in the
biotech space," said Ms. Layman. "ZILRETTA is a phenomenal product
that has the potential to help so many patients, and I look forward
to helping it become the leading intra-articular treatment for OA
knee pain. I am also tremendously enthusiastic about the
transformative potential of both FX201 and FX301."
Before joining Flexion, Ms. Layman served as Vice President,
Global Sales and Marketing at Lantheus Medical Imaging where she
was a member of the executive leadership team. During her nearly
10-year tenure, she was responsible for global sales, marketing,
communications, health policy, pricing and reimbursement,
commercial development and international operations. Prior to
Lantheus, she served as Executive Marketing Director at Forest
Laboratories (now Allergan), where she led the cardiovascular
franchise through the successful launch of its lead product,
Bystolic. Ms. Layman also held senior marketing positions at Altus
Pharmaceuticals (now Vertex) and Sepracor (now Sunovion), where she
launched Xopenex MDI and Lunesta, building and integrating the
market access function across the business. She began her career
with TAP Pharmaceuticals (now Takeda Oncology) where her positions
ranged from sales representative to National Marketing Director,
Gastroenterology and Oncology.
Ms. Layman holds a B.A. from Ithaca College and an executive
M.B.A. from the Kellogg School of Management at Northwestern
University.
Indication and Select Important Safety Information for
ZILRETTA (triamcinolone acetonide extended-release injectable
suspension)
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of osteoarthritis pain
of the knee.
Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA is
contraindicated in patients who are hypersensitive to triamcinolone
acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has
not been evaluated and should not be administered by epidural,
intrathecal, intravenous, intraocular, intramuscular, intradermal,
or subcutaneous routes. ZILRETTA should not be considered safe for
epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural
and Intrathecal Administration: Serious neurologic
events have been reported following epidural or intrathecal
corticosteroid administration. Corticosteroids are not approved for
this use.
- Hypersensitivity reactions: Serious
reactions have been reported with triamcinolone acetonide
injection. Institute appropriate care if an anaphylactic reaction
occurs.
- Joint infection and damage: A marked
increase in joint pain, joint swelling, restricted motion, fever
and malaise may suggest septic arthritis. If this occurs, conduct
appropriate evaluation and if confirmed, institute appropriate
antimicrobial treatment.
Adverse Reactions: The most commonly
reported adverse reactions (incidence ≥1%) in clinical studies
included sinusitis, cough, and contusions.
Please
see ZilrettaLabel.com for
full Prescribing Information.
About ZILRETTA On October 6, 2017,
ZILRETTA was approved by the U.S. FDA as the first and
only extended-release intra-articular therapy for patients
confronting osteoarthritis-related knee pain. ZILRETTA employs
proprietary microsphere technology combining triamcinolone
acetonide — a commonly administered, short-acting corticosteroid —
with a poly lactic-co-glycolic acid (PLGA) matrix to provide
extended pain relief. The pivotal Phase 3 trial on which the
approval of ZILRETTA was based showed that ZILRETTA significantly
reduced knee pain for 12 weeks, with some people experiencing pain
relief through Week 16.
About Osteoarthritis (OA) of the Knee OA, also
known as degenerative joint disease, affects more than 30 million
adults living in the U.S. and accounts for more than $185
billion in annual expenditures. In 2016, more than 15 million
Americans were diagnosed with OA of the knee and the average
age of physician-diagnosed knee OA has fallen by 16
years, from 72 in the 1990s to 56 in the 2010s. The prevalence of
OA is expected to continue to increase as a result of aging,
obesity and sports injuries. Each year, approximately five million
OA patients receive either an immediate-release corticosteroid or
hyaluronic acid intra-articular injection to manage their knee
pain.
About Flexion Therapeutics Flexion Therapeutics
(Nasdaq:FLXN) is a biopharmaceutical company focused on the
development and commercialization of novel, local therapies for the
treatment of people with musculoskeletal conditions, beginning with
osteoarthritis, the most common form of arthritis. Flexion is
building a portfolio of non-opioid therapeutics, with the goal of
making a meaningful difference in the lives of patients. The
Company's core values are focus, ingenuity, tenacity, transparency
and fun. Visit flexiontherapeutics.com.
Forward-Looking Statements This release
contains forward-looking statements that are based on the current
expectations and beliefs of Flexion. Statements in this press
release regarding matters that are not historical facts, including,
but not limited to, statements relating to the future of Flexion,
the expected benefits of Flexion's appointment of Ms. Layman as
CCO, the potential of ZILRETTA and Flexion’s product pipeline, and
expected increases in the prevalence of OA 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, whether we are able to
retain key employees including Ms. Layman; the risk that we may not
be able to successfully maintain an effective sales force to
commercialize ZILRETTA; competition from alternative therapies; the
risk that we may not be able to maintain and enforce our
intellectual property, including intellectual property related to
ZILRETTA; the risk that ZILRETTA may not be successfully
commercialized or adopted; risks regarding our ability to obtain
adequate reimbursement from payers for ZILRETTA; risks related to
the manufacture and distribution of ZILRETTA, including our
reliance on sole sources of supply and distribution; risks inherent
in developing novel product candidates; and other risks and
uncertainties described in our filings with the Securities and
Exchange Commission (SEC), including under the heading "Risk
Factors" in our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2019 filed with the SEC on November 7, 2019 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.
Contacts:
Scott Young Vice President, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7194
syoung@flexiontherapeutics.com
Julie Downs Associate Director, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7137
jdowns@flexiontherapeutics.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/1b70f149-51c4-426d-9f91-e41adb4673c4
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