Flexion Therapeutics and Xenon Pharmaceuticals Announce Flexion’s Acquisition of an Investigational NaV1.7 Inhibitor for th...
September 09 2019 - 4:01PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) and Xenon Pharmaceuticals
Inc. (Nasdaq:XENE) today announced that the companies have entered
into a definitive agreement that provides Flexion with the global
rights to develop and commercialize XEN402, a NaV1.7 inhibitor, for
the management of post-operative pain.
Flexion’s new preclinical program, known as FX301, will consist
of XEN402 formulated for extended release from a thermosensitive
hydrogel. The initial development of FX301 is intended to support
administration as a peripheral nerve block for control of
post-operative pain. Within minutes following injection, the
thermosensitive formulation has been shown to transition from a
liquid to a gel, an effect that provides local delivery of XEN402
near target nerves for up to a week. Unlike typical local
anesthetics, the selective pharmacology of XEN402 has the potential
to provide effective pain relief while preserving motor function.
As such, FX301 is expected to enable ambulation, rapid discharge,
and early rehabilitation following musculoskeletal surgery.
Under the terms of the agreement, Flexion acquired the global
rights to the XEN402 program including a broad patent estate as
well as the associated non-clinical, clinical and manufacturing
components. As consideration for the acquisition, Flexion paid
Xenon an upfront payment of $3 million. In addition, Xenon will
also be eligible for various CMC, development and regulatory
milestone payments of up to $9 million through initiation of a
Phase 2 proof of concept (PoC) clinical trial. Following successful
PoC, Xenon may be entitled to future clinical development and
global regulatory approval milestone payments of up to $40.75
million, commercialization milestone payments of up to $75 million,
as well as future sales royalties ranging from mid-single to
low-double digit percentages. As part of the agreement, Flexion
will assume Xenon’s obligation to pay a low single-digit percentage
of sales royalty to Teva Pharmaceuticals International GmbH.
Flexion anticipates initiating FX301 clinical trials in 2021.
Commenting on the deal Michael Clayman, M.D., President and
Chief Executive Officer of Flexion said, “FX301 is a natural fit
for Flexion as it leverages our deep understanding of
musculoskeletal pain and our demonstrated formulation expertise.
Post-operative opioid use is considered a key cause of subsequent
opioid use disorder, particularly following musculoskeletal
surgery. We believe FX301 may directly address a substantial
medical challenge by potentially providing durable and meaningful
post-operative pain relief, while sparing motor function.
Importantly, Xenon has amassed an extensive amount of pre-clinical
data from in vivo pain models, and XEN402 has been previously
tested in multiple human clinical trials, which we believe can
accelerate our development efforts to move FX301 into the
clinic.”
Dr. Simon Pimstone, Xenon’s Chief Executive Officer added,
“We believe that FX301 holds great potential as a local therapy for
post-operative pain based on in vivo data with XEN402 that
demonstrated good efficacy when delivering this drug to the target
site at high concentration. Thus, we believe that locally
administered, long acting delivery of XEN402 may represent a
promising new way to address post-operative pain. With their
experience developing and commercializing novel and locally acting
therapies, we are excited that Flexion is committed to advancing
XEN402 in their proprietary formulation as FX301. We look forward
to the progression of FX301 as it advances through clinical
development.”
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 three years, Flexion
has been named one of the Best Places to Work by the Boston
Business Journal, and Flexion was recognized as a Top Place to
Work in Massachusetts by The Boston Globe in
2017 and 2018. For more information, visit
www.flexiontherapeutics.com.
About Xenon Pharmaceuticals Inc. Xenon
Pharmaceuticals (Nasdaq:XENE) is a clinical stage biopharmaceutical
company committed to developing innovative therapeutics to improve
the lives of patients with neurological disorders, including rare
central nervous system (CNS) conditions. Xenon is advancing a novel
product pipeline of neurology therapies to address areas of high
unmet medical need, with a focus on epilepsy. For more information,
please visit www.xenon-pharma.com.
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 or Xenon; Flexion’s plans to develop and commercialize
FX301, including the expected timing of clinical and regulatory
events; future payments, if any, under the purchase agreement
between Flexion and Xenon; and the potential therapeutic and other
benefits of FX301, are forward-looking statements. These
forward-looking statements are based on expectations and
assumptions of Flexion’s and Xenon’s respective management 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 and commercializing FX301, including
potential delays in initiating clinical trials; the fact that the
results of prior preclinical and clinical studies involving XEN402
may not predict results of subsequent preclinical or clinical
studies; the risk that Flexion may incur unexpected expenses or
cash requirements; reliance on third parties to manufacture FX301;
the risk that Flexion may not be able to maintain and enforce its
intellectual property rights, including its rights to acquired
intellectual property related to FX301; the risk that Xenon may not
receive additional payments pursuant to the agreement with Flexion;
competition from alternative and/or standard of care therapies;
regulatory developments and safety issues, including difficulties
in obtaining and maintaining regulatory approvals to conduct
clinical trials and market FX301; risks related to key employees,
markets, economic conditions, health care reform, prices and
reimbursement rates; and other risks and uncertainties described in
filings with the Securities and Exchange
Commission (SEC). The forward-looking statements in this press
release speak only as of the date of this press release, and
Flexion and Xenon undertake no obligation to update or revise any
of the statements. Flexion and Xenon caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release.
“Xenon” and the Xenon logo are registered trademarks or
trademarks of Xenon Pharmaceuticals Inc. in various
jurisdictions. All other trademarks belong to their respective
owner.
Investor/Media Contacts:
Scott
Young
Flexion Therapeutics, Inc. T: 781-305-7194
syoung@flexiontherapeutics.com
Jodi Regts Xenon Pharmaceuticals Inc. T: 604-484-3353
investors@xenon-pharma.com
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