Aquestive Therapeutics Receives FDA Approval for Exservan™ (riluzole) Oral Film
November 25 2019 - 8:00AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products to solve therapeutic problems, today
announced that Exservan™ (riluzole) Oral Film received early-action
approval from the U.S. Food and Drug Administration (FDA) for the
treatment of amyotrophic lateral sclerosis (ALS), an orphan
disease.
“We received full FDA approval for Exservan in
advance of our PDUFA action date. We appreciate the ongoing
feedback from the FDA and its early-action approval. We
anticipate that Exservan, via our orally administered PharmFilm®
dosage form, will bring meaningful treatment to patients who are
diagnosed with ALS and face difficulties swallowing or
administering traditional forms of medication,” said Keith J.
Kendall, Chief Executive Officer of Aquestive. “In line with
our stated objectives, we licensed this product to Zambon S.p.A.
for development and commercialization in the EU. We are
continuing the dialogue with potential licensees for the US
commercial rights.”
Exservan (riluzole) Oral Film is now approved
for the treatment of ALS, a debilitating and rare disease affecting
as many as 30,000 Americans1 and 52,000 Europeans2. Exservan
will now fill a critical need in the armamentarium for ALS patients
because it can be administered safely and easily, twice daily,
without water where many patients have trouble swallowing.
Development initiatives conducted by Aquestive have included
studies demonstrating Exservan's pharmacokinetic bioequivalence to
the reference listed drug, Rilutek®, as well as additional studies
to assess patients' ability to swallow Exservan. Exservan received
FDA orphan drug designation in January 2018.
About Aquestive
TherapeuticsAquestive Therapeutics is a specialty
pharmaceutical company that applies innovative technology to solve
therapeutic problems and improve medicines for patients. Aquestive
is advancing a late-stage proprietary product pipeline to treat CNS
conditions and provide alternatives to invasively administered
standard of care therapies. The Company also collaborates with
other pharmaceutical companies to bring new molecules to market
using proprietary, best-in-class technologies, like PharmFilm®, and
has proven capabilities for drug development and
commercialization.
PharmFilm® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. All other
trademarks referenced herein are the property of their respective
owners.
Forward-Looking StatementThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “believe,” "anticipate," "plan," "expect,"
"estimate," "intend," "may," "will," or the negative of those
terms, and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements may
include, but are not limited to, statements regarding therapeutic
benefits of Exservan (riluzole) Oral Film and other product
candidates; statements about our growth and future financial and
operating results and financial position, ability to advance
Exservan (riluzole) Oral Film to the EU and US markets, regulatory
approvals and pathways, clinical trial timing and plans, short-term
and long-term liquidity and cash requirements, cash funding and
cash burn, business strategies, market opportunities, and other
statements that are not historical facts.
These forward-looking statements are based on
our current expectations and beliefs and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Such risks and uncertainties include, but are not limited to, risks
associated with the Company's development work, including any
delays or changes to the timing, cost and success of our product
development activities and clinical trials; risk of delays in FDA
or other governmental approval of our drug candidates or failure to
receive approval; risk inherent in commercializing a new product
(including technology risks, financial risks, market risks and
implementation risks and regulatory limitations); risk that a
competitor obtains orphan drug exclusivity and blocks our product
for the same indication for seven years; risk of development of our
sales and marketing capabilities; risk of legal costs associated
with and the outcome of our patent litigation challenging third
party at risk generic sale of our proprietary products; risk of
sufficient capital and cash resources, including access to
available debt and equity financing and revenues from operations,
to satisfy all of our short-term and longer term cash requirements
and other cash needs, at the times and in the amounts needed; risk
of failure to satisfy all financial and other debt covenants and of
any default; risk related to government claims against Indivior for
which we license, manufacture and sell Suboxone and which accounts
for the substantial part of our current operating revenues; risks
associated with Indivior’s announcement of its intention to cease
production of its authorized generic buprenorphine naloxone film
product, including the impact from loss of orders for the
authorized generic product and risk of eroding market share for
Suboxone and risk of sunsetting product; risks related to the
outsourcing of certain sales, marketing and other operational and
staff functions to third parties; risk of the rate and degree of
market acceptance of our products and product candidates; the
success of any competing products, including generics; risk of the
size and growth of our product markets; risk of compliance with all
FDA and other governmental and customer requirements for our
manufacturing facilities; risks associated with intellectual
property rights and infringement claims relating to the Company's
products; risk of unexpected patent developments; the impact of
existing and future legislation and regulatory provisions on
product exclusivity; legislation or regulatory action affecting
pharmaceutical product pricing, reimbursement or access; claims and
risks that may arise regarding the safety or efficacy of the
Company's products and product candidates; risk of loss of
significant customers; risks related to legal proceedings,
including patent infringement, investigative and antitrust
litigation matters; changes in governmental laws and regulations;
risk of product recalls and withdrawals; uncertainties related to
general economic, political, business, industry, regulatory and
market conditions and other unusual items; and other risks and
uncertainties affecting the Company including those described in
the "Risk Factors" section and in other sections included in the
Company's Annual Report on Form 10‑K filed with the SEC on
March 14, 2019 and in our quarterly reports on Form 10-Q. Given
these uncertainties, you should not place undue reliance on these
forward-looking statements, which speak only as of the date made.
All subsequent forward-looking statements attributable to us or any
person acting on our behalf are expressly qualified in their
entirety by this cautionary statement. The Company assumes no
obligation to update forward-looking statements or outlook or
guidance after the date of this press release whether as a result
of new information, future events or otherwise, except as may be
required by applicable law.
Investor inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
Media inquiriesMark Corbaemark.corbae@icrinc.com203-682-8288
1 Sources: CDC, “National Amyotrophic
Lateral Sclerosis (ALS) Registry FAQ”
https://wwwn.cdc.gov/als/alsfaq.aspx (Accessed January 2018), ALS
Association, “Quick Facts about ALS”
http://www.alsa.org/news/media/quick-facts.html (Accessed January
2018)
2 Sources: European Medicines Agency,
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192155
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