Flexion Therapeutics Announces Issuance of New U.S. Patent Covering FX201 a Gene Therapy Product Candidate for the Treatment ...
June 05 2019 - 08:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the
U.S. Patent and Trademark Office (USPTO) has issued patent number
10,301,645 for FX201, the company's gene therapy product candidate.
The patent covers the composition of matter and method of use of
FX201 in the treatment of osteoarthritis (OA).
U.S. Patent No. 10,301,645 was awarded to Baylor College of
Medicine in Houston, Texas. In December of 2017, Flexion acquired
the global rights to FX201 from GeneQuine Biotherapeutics GmbH, and
as part of that agreement, Flexion obtained an exclusive license to
the underlying intellectual property rights from Baylor for human
applications. "OA is a serious disease that is progressive and
incurable, and we believe that by persistently controlling
inflammation in the joint, FX201 may hold the potential to both
provide lasting pain relief and modify the underlying disease,”
said Michael Clayman, M.D., President and Chief Executive Officer
of Flexion. “While still early days for the program, the issuance
of this patent represents one important step in our journey to
bring FX201 to the market." FX201 is a locally administered
gene therapy product candidate designed to stimulate the production
of an anti-inflammatory protein, interleukin-1 receptor antagonist
(IL-1Ra), whenever inflammation is present within the joint.
Inflammation is a known cause of pain, and chronic inflammation is
thought to play a major role in the progression of OA. By
persistently suppressing inflammation, Flexion believes FX201 holds
the potential to both reduce OA pain and modify the disease.
Flexion is currently completing Good Laboratory Practice (GLP)
toxicology studies and has successfully transferred the
manufacturing process for FX201 to a U.S. based contract
manufacturing organization. The company expects to file an
Investigational New Drug application and initiate clinical trials
in the second half of 2019.
About Osteoarthritis (OA) of the Knee OA, also
known as degenerative joint disease, affects more than 30 million
Americans 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, more than 15 million Americans are treated for
OA-related knee pain, and 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, a type of degenerative arthritis. The
company's core values are focus, ingenuity, tenacity, transparency
and fun. For the past two years, Flexion has been named one of the
Best Places to Work by the Boston Business Journal, and a Top
Place to Work in Massachusetts by The Boston Globe.
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 to develop and commercialize FX201, including
the expected timing of clinical and regulatory events; expected
increases in the rate of individuals with OA of the knee; and the
potential therapeutic and other benefits of FX201, 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 developing FX201; the fact that the results of
prior preclinical studies may not predict results of subsequent
preclinical or clinical studies; the risk that we may incur
unexpected expenses or cash requirements; our reliance on third
parties to manufacture FX201; the risk that we may not be able to
maintain and enforce our intellectual property, including licensed
intellectual property related to FX201; the risk the license
agreement with Baylor could be terminated early if we do not comply
with our obligations; competition from alternative therapies;
regulatory developments and safety issues, including difficulties
in obtaining and maintaining regulatory approvals to conduct
clinical trials and market FX201; 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 Quarterly Report
on Form 10-Q for the quarter ended March 31, 2019. 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 T: 781-305-7194
syoung@flexiontherapeutics.com
Julie Downs Senior Manager, Corporate Communications &
Investor Relations T: 781-305-7137
jdowns@flexiontherapeutics.com
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