Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for the
Company’s drug candidate AQST-108, a “first of its kind” oral
sublingual film formulation delivering systemic epinephrine that is
in development for the treatment of allergic reactions (Type 1),
including anaphylaxis, using Aquestive’s proprietary PharmFilm®
technologies.
Fast Track is an FDA process designed to
facilitate the development and expedite the review of therapies to
treat serious conditions and fill unmet medical needs. Programs
with Fast Track designation may benefit from early and frequent
communication with the FDA, eligibility for FDA accelerated
approval and priority review, if relevant criteria are met, in
addition to a rolling submission of the marketing application.
Aquestive received confirmation from the FDA in
July 2020 that the agency completed its safety review of its IND
and concluded that the Company could proceed with the first planned
PK clinical trials of AQST-108. As such, the Company expects
to commence its first PK clinical trial utilizing a four-treatment
crossover design to compare the pharmacokinetics and
pharmacodynamics of AQST-108 to that of epinephrine administered as
subcutaneous and intramuscular injections before the end of the
third quarter of 2020.
“Fast Track designation confirms the unmet
medical need for patients who are at risk for allergic reactions
including anaphylaxis but reluctant and hesitant to use the
standard of care, subcutaneous and intramuscular injections. We
believe that AQST-108, a highly portable, easy-to-administer
sublingual film formulation delivering systemic epinephrine,
satisfies this unmet medical need for this large underserved
patient population,” said Keith J. Kendall, Chief Executive Officer
of Aquestive. “Our first planned PK clinical trial will begin this
quarter.”
About AQST-108AQST-108 is a
“first of its kind” oral sublingual film formulation delivering
systemic epinephrine for the treatment of allergic reactions (Type
1), including anaphylaxis, using Aquestive’s proprietary PharmFilm®
technologies. Anaphylaxis is a potentially life-threatening
systemic allergic reaction, with an estimated incidence of 50 to
112 episodes per 100,000 people per year. The frequency of hospital
admissions for anaphylaxis has increased 500-700% in the last 10-15
years.1 The most common causes of reactions that can include
anaphylaxis are medications, foods (such as peanuts), and venom
from insect stings. Epinephrine injection is the current standard
of treatment intended to reverse the potentially severe
manifestation of anaphylaxis, which may include red rash, throat
swelling, respiratory problems, gastrointestinal distress and loss
of consciousness.
About Aquestive
TherapeuticsAquestive Therapeutics is a 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.
Forward-Looking Statement
This 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
include, but are not limited to, statements regarding therapeutic
benefits and plans and objectives for regulatory approvals of
AQST-108, LibervantTM and our other product candidates; ability to
obtain FDA approval and advance AQST-108, Libervant and our other
product candidates to the market, statements about our growth and
future financial and operating results and financial position,
regulatory approval and pathways, clinical trial timing and plans,
our and our competitors’ orphan drug approval and resulting drug
exclusivity for our products or products of our competitors,
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 also subject to the uncertain impact
of the COVID-19 global pandemic on our business including with
respect to our clinical trials including site initiation, patient
enrollment and timing and adequacy of clinical trials; on
regulatory submissions and regulatory reviews and approvals of our
product candidates; pharmaceutical ingredient and other raw
materials supply chain, manufacture, and distribution; sale of and
demand for our products; our liquidity and availability of capital
resources; customer demand for our products and services;
customers’ ability to pay for goods and services; and ongoing
availability of an appropriate labor force and skilled
professionals. Given these uncertainties, the Company is
unable to provide assurance that operations can be maintained as
planned prior to the COVID-19 pandemic.
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 and plans; risk of
delays in FDA approval of Libervant and our other drug candidates
or failure to receive approval; risk of our ability to demonstrate
to the FDA “clinical superiority” within the meaning of the FDA
regulations of our drug candidate Libervant relative to
FDA-approved diazepam rectal gel and nasal spray products including
by establishing a major contribution to patient care within the
meaning of FDA regulations relative to the approved products as
well as risks related to other potential pathways or positions
which are or may in the future be advanced to the FDA to overcome
the seven year orphan drug exclusivity granted by the FDA for the
approved nasal spray product of a competitor in the U.S. and there
can be no assurance that we will be successful; risk that a
competitor obtains FDA orphan drug exclusivity for a product with
the same active moiety as any of our other drug products for which
we are seeking FDA approval and that such earlier approved
competitor orphan drug blocks such other product candidates in the
U.S. for seven years for the same indication; risk inherent in
commercializing a new product (including technology risks,
financial risks, market risks and implementation risks and
regulatory limitations); risks and uncertainties concerning any
potential monetization of royalty and other revenue stream of
KYNMOBI (apomorphine) and of sufficiency of net proceeds of any
such monetization after satisfaction of and compliance with 12.5%
Senior Notes obligations, as applicable; 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; risk
associated with Indivior’s cessation of 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
product and product candidates; the success of any competing
products, including generics; risk of the size and growth of our
product markets; risks 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 actions 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
government 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 uncertainties affecting the Company
described in the “Risk Factors” section and in other sections
included in our Annual Report on Form 10‑K, in our Quarterly
Reports on Form 10-Q, and in our Current Reports on Form 8-K filed
with the Securities Exchange Commission (SEC). Given those
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.
PharmFilm® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. All other
registered trademarks referenced herein are the property of their
respective owners.
Investor Inquiries: Stephanie Carrington
stephanie.carrington@icrinc.com 646-277-1282
1 Epidemiology of anaphylaxis. Tejedor Alonso MA, Moro M, Mugica
Garcia MV, Clin Exp Allergy. 45(6):1027-39, Jun 2015.
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