Flexion Therapeutics Announces Acquisition of Novel, Non-Opioid Asset for Osteoarthritis of the Knee
December 13 2017 - 3:05PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced it has
entered into a definitive agreement with GeneQuine Biotherapeutics
GmbH to acquire the global rights to GQ-203. As part of the
agreement, Flexion obtained an exclusive license to the underlying
intellectual property rights for human use of GQ-203 from Baylor
College of Medicine. GQ-203, now known as FX201, is a preclinical,
non-opioid, intra-articular therapeutic being developed for
symptomatic pain relief and disease modification in patients with
osteoarthritis (OA) of the knee.
As part of the deal, Flexion will make an upfront payment of $2
million to GeneQuine and may incur milestone payments of up to $8.7
million through Phase 2 proof of concept (PoC). Following
successful PoC, Flexion may incur up to $54 million in future
development and global regulatory approval milestone payments, with
Baylor also receiving a low single-digit royalty on net sales of
FX201. After taking into account Flexion’s payment obligations in
connection with the acquisition and the anticipated preclinical and
clinical development costs for FX201, the company still expects
current cash to bring Flexion to profitability.
FX201 is a locally administered gene therapy 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, FX201
may both reduce pain and modify the disease.
“We believe FX201 could represent a next-generation therapeutic
approach for OA, and it supports our long-term objective of having
a pipeline of high-quality drug candidates that are positioned to
enter the market as ZILRETTATM matures,” said Michael Clayman,
M.D., President and Chief Executive Officer of Flexion. “With its
potential to deliver an unprecedented duration of pain relief and
possibly arrest the progression of disease, FX201 could transform
the treatment of OA, while fitting nicely within our commercial
infrastructure.”
Based on strong preclinical data, a single injection of FX201
could potentially enable expression of IL-1Ra in an osteoarthritic
joint for a least a year. Initially, FX201 will be targeted towards
a subpopulation of patients who confront aggressive OA of the knee
and would be expected to differentially benefit from this therapy.
Flexion expects to hold a pre-Investigational New Drug meeting with
the U.S. Food and Drug Administration in the first half of 2018,
and pending successful results from preclinical studies, the
company aims to initiate a Phase 1 clinical trial in 2019.
About Osteoarthritis (OA) of the KneeOA is the
most common joint disease, affecting more than 30 million Americans
and accounting 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 TherapeuticsFlexion Therapeutics
(Nasdaq:FLXN) 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, a type of degenerative arthritis. The company's core
values are focus, ingenuity, tenacity, transparency and fun.
Flexion was named one of the Boston Business Journal's 2017 Best
Places to Work and one of the Top Places 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
financial results and Flexion’s ability to reach profitability; the
market potential of FX201; 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 the acquisition of and the
process of developing FX201; the fact that the results of prior
preclinical studies may not predict results of subsequent
preclinical or clinical studies; risks associated with the process
of commercializing ZILRETTA, including the extent to which ZILRETTA
is adopted by physicians and patients and is reimbursed by third
party payors; the risk that we may incur unexpected expenses or
cash requirements; our reliance on third parties to manufacture
FX201 and ZILRETTA; the risk that we may not be able to maintain
and enforce our intellectual property, including intellectual
property acquired and licensed in 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
market FX201 and our other products; 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 September 30,
2017 filed with the SEC on November 6, 2017. 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
Sr. Director, Corporate Communications & Investor
RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsManager, Corporate CommunicationsFlexion
Therapeutics, Inc.T: 781-305-7137jdowns@flexiontherapeutics.com
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