Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that it
has entered into an exclusive license agreement with HK Tainuo and
Jiangsu Tainuo (a subsidiary of China Shijiazhuang Pharmaceutical
Co, Ltd.) for the development and commercialization of ZILRETTA
(triamcinolone acetonide extended-release injectable suspension) in
Greater China (consisting of mainland China, Hong Kong and Macau,
and Taiwan).
Under the terms of the agreement, HK Tainuo will pay Flexion an
upfront payment of $10 million. Flexion will also be eligible to
receive up to $32.5 million in aggregate development, regulatory
and commercial sales milestone payments. HK Tainuo will be
responsible for the clinical development, product registration and
commercialization of ZILRETTA in Greater China.
Flexion will be solely responsible for the manufacture and
supply of ZILRETTA to HK Tainuo for all clinical and commercial
activities. The terms related to product manufacturing and supply,
including pricing and minimum purchase requirements agreed to in
the license agreement, will be covered by a separate supply
agreement. HK Tainuo expects to be able to file a Clinical Trial
Application for ZILRETTA with the China National Medical Products
Administration by the end of 2020 and to begin clinical studies in
China as soon as possible thereafter.
Shanghai Yafo Capital Asset Management Co., Ltd. acted as
financial advisor on this transaction for Flexion.
Withdrawal of Revenue Guidance for 2020
Due to the extraordinary impacts of the novel coronavirus global
pandemic, Flexion has determined that it is prudent to withdraw its
previous ZILRETTA revenue guidance for 2020. The company’s decision
was based on the potential impact and unknown duration of recent
actions taken by federal, state and local governments to contain
the spread of the coronavirus, as well as the impact of voluntary
“social distancing” efforts and various mitigation actions
implemented by healthcare practices across the country. Flexion
expects to provide an update to its revenue guidance when it has
more clarity regarding the duration and magnitude of the impact
from the coronavirus pandemic.
Temporary Suspension of Clinical Trials
Flexion is temporarily suspending its active clinical trials
including the Phase 1 trial evaluating the safety and tolerability
of FX201, its investigational intra-articular gene therapy product
candidate, in patients with osteoarthritis (OA) of the knee, and
the Phase 2 trial evaluating the efficacy of ZILRETTA in patients
with shoulder OA or adhesive capsulitis. The decision was based on
the recent guidance from the U.S. Food and Drug Administration
(FDA) to ensure the safety of trial participants and minimize risk
to trial integrity from disruptions caused by COVID-19.
The company continues to advance the preclinical program for
FX301, its product candidate being developed as a locally
administered peripheral nerve block for control of post-operative
pain. Flexion continues to anticipate the initiation of FX301
clinical trials in 2021.
ZILRETTA Commercial Supply
Flexion remains comfortable with the amount of its ZILRETTA
inventory and reconfirmed it has at least 10 months of finished
goods available in the U.S. In addition, the company has 12 months
of active pharmaceutical ingredient (triamcinolone acetonide)
available at its manufacturing site.
Commenting on the business updates, Michael Clayman, M.D.,
President and Chief Executive Officer of Flexion said, “These are
unprecedented and challenging times for everyone involved in the
delivery of healthcare in the United States. The well-being of our
patients, customers and employees remains our top priority, and our
decision to suspend clinical trials is consistent with that goal.
We look forward to resuming the ZILRETTA and FX201 clinical trials
at the earliest feasible opportunity. In the meantime, we remain
resolute in our commitment to ensuring that Flexion remains well
positioned to provide meaningful medicines to patients in need and
value to our investors for years to come. In that vein, we are
delighted by the opportunity to partner with HK Tainuo and Jiangsu
Tainuo as they work to develop and commercialize ZILRETTA in
Greater China. OA of the knee affects more than 100 million people
in China, and we are confident in the important role ZILRETTA can
play in helping these patients manage their OA knee pain.”
Flexion’s management will provide a further update on its
business operations and cost-containment efforts in response to the
coronavirus pandemic when the company releases its first quarter
2020 financial results in May.
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 patients with musculoskeletal
conditions, beginning with osteoarthritis, the most common form of
arthritis. 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;
expected payments and activities to be conducted under the
licensing agreement with HK Tainuo and Jiangsu Tainuo; expected
regulatory and clinical developments and timelines; anticipated
timelines related to ZILRETTA commercial supply; expected increases
in the rate of individuals with OA of the knee; 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, the fact that the
licensing agreement with HK Tainuo and Jiangsu Tainuo is subject to
early termination; competition from alternative therapies; the risk
that we or HK Tainuo and Jiangsu Tainuo may not be able to maintain
and enforce intellectual property, including intellectual property
related to ZILRETTA; the risk that ZILRETTA may not be successfully
developed, approved or commercialized or adopted in Greater China;
risks related to the manufacture and distribution of ZILRETTA,
including our reliance on sole sources of supply and distribution;
unanticipated depletion of current ZILRETTA finished product or
active pharmaceutical ingredient inventory; risks related to
clinical trials, including potential delays, safety issues or
negative results; risks related to the novel coronavirus pandemic
and actions taken to slow its spread; 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 Annual Report on
Form 10-K for the year ended December 31, 2019 filed with
the SEC on March 12, 2020 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.
Contact:
Scott YoungVice President, Corporate Communications &
Investor RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsAssociate Director, Corporate Communications &
Investor RelationsFlexion Therapeutics, Inc.T:
781-305-7137jdowns@flexiontherapeutics.com
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