Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company advancing current standards of care to solve patients’
problems through simplifying complex delivery methods, will present
three abstracts recapping positive data from its completed
pharmacokinetic studies of AQST-109 (epinephrine sublingual film)
at the American College of Allergy Asthma and Immunology (ACAAI)
Annual Scientific Meeting, which will be held from November 10-14,
in Louisville, Kentucky.
“Not only are we excited to share the positive
results from our two completed AQST-109 pharmacokinetic studies,
but we are also honored to have results selected for presentation
as a Distinguished Industry Oral Abstract, with the opportunity to
highlight the formulation and dosage from the podium,” said Ken
Truitt, M.D., Aquestive’s Chief Medical Officer. “We look forward
to connecting with leaders in the allergy community and providing
insight on how our research has the potential to provide an
important advance in the treatment of acute allergic
reactions.”
Poster Details:
Abstract Title: Pharmacokinetics Study of
Epinephrine Sublingual Film: Results from The Formulation and
Dosage Selection Presentation ID:
D001Session: Distinguished Industry Oral
Abstracts- Session BPodium Presentation Time:
Saturday, November 12, 4:53 - 5:03 PM ETLocation:
Room M104-M107Presenting Author: Dr. John
Oppenheimer, MD (UMDNJ Rutgers University School of Medicine)
Abstract Title: Minimal Impact of Food,
Drink, Or Temperature on The Pharmacokinetics of a Sublingual Film
Using a Novel Prodrug of Epinephrine (DESF)Presentation
ID: ID: P022Category: Adverse Drug
Reactions, Insect Reactions, AnaphylaxisPresentation
Time: Sunday, November 13, 12:35 PM
ETLocation: Exhibit Hall (Upper Concourse),
Monitor 9Presenting Author: Holly Ponichtera, PhD
(Aquestive Therapeutics)
Abstract Title: Results of a Repeat Dose
Study on The Pharmacokinetics of a Sublingual Film using a Novel
Prodrug of Epinephrine (DESF)Presentation ID: ID:
P021Category: Adverse Drug Reactions, Insect
Reactions, AnaphylaxisPresentation
Time: Sunday, November 13, 12:20 PM
ETLocation: Exhibit Hall (Upper Concourse),
Monitor 9Presenting Author: Holly Ponichtera, PhD
(Aquestive Therapeutics)
About AnaphylaxisAnaphylaxis is
a serious systemic hypersensitivity reaction with rapid onset and
potentially fatal. As many as 49 million people in the United
States are at chronic risk for anaphylaxis. Lifetime prevalence is
at least 5%, or more than 16 million people in the United States.
Direct costs of anaphylaxis have been estimated at $1.2 billion per
year, with direct expenditures of $294 million for epinephrine, and
indirect costs of $609 million. The frequency of hospital
admissions for anaphylaxis has increased 500-700% in the last 10-15
years. 52% of patients, who previously experienced anaphylaxis, had
never received an epinephrine autoinjector prescription, and 60%
did not have an autoinjector currently available. The most common
causes of anaphylaxis are foods (such as peanuts), venom from
insect stings, and medications. Epinephrine injection is the
current standard of treatment intended to reverse the severe
manifestation of anaphylaxis, which may include skin rash, throat
swelling, respiratory problems, gastrointestinal distress, and loss
of consciousness.
About AQST-109AQST-109 is a
polymer matrix-based epinephrine prodrug administered as a
sublingual film that is applied under the tongue for the rapid
delivery of epinephrine. The product is similar in size to a
postage stamp, weighs less than an ounce, and begins to dissolve on
contact. No water or swallowing is required for administration. The
packaging for AQST-109 is thinner and smaller than an average
credit card, can be carried in a pocket, and is designed to
withstand weather excursions such as exposure to rain and/or
sunlight.
About Aquestive
TherapeuticsAquestive Therapeutics, Inc. (NASDAQ: AQST) is
a pharmaceutical company advancing current standards of care to
solve patients’ problems by simplifying complex delivery methods.
Aquestive is developing pharmaceutical products to deliver complex
molecules through alternative administrations to invasive and
inconvenient standard of care therapies. Aquestive has five
licensed commercialized products which are marketed by our
licensees in the U.S. and around the world. The Company is the
exclusive manufacturer of these licensed products. The Company also
collaborates with pharmaceutical companies to bring new molecules
to market using proprietary, best-in-class technologies, like
PharmFilm®, and has proven drug development and commercialization
capabilities. The Company is advancing an early stage product
pipeline for the treatment of severe allergic reactions, including
anaphylaxis. The Company has also developed a product pipeline
focused on treating diseases of the central nervous system, or CNS.
The Company's production facilities are located in Portage,
Indiana, and our corporate headquarters, sales and
commercialization operations and primary research laboratory
facilities are based in Warren, New Jersey. For more information,
visit Aquestive.com and follow us on LinkedIn.
Forward Looking
StatementCertain statements in this press release include
“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 the advancement and related timing of AQST-109
through the regulatory and development pipeline and clinical and
business strategies, market opportunities, and other statements
that are not historical facts. These forward-looking statements are
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 for AQST-109 and our
other product candidates; risk of delays by the United States Food
and Drug Administration (FDA) in approving Libervant® (diazepam)
Buccal Film for U.S. market; risk of our ability to demonstrate to
the FDA “clinical superiority” of Libervant within the meaning of
the FDA regulations relative to the FDA-approved diazepam nasal
spray product of an unrelated company competitor in the U.S.,
including by establishing a major contribution to patient care
within the meaning of FDA regulations relative to the approved
product, 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, and there can be no assurance
that we will be successful; risk of delays in FDA approval of
AQST-109 and our other drug candidates, or failure to receive FDA
approval at all; 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 in obtaining market access for other reasons; risk
inherent in commercializing a new product (including technology
risks, financial risks, market risks and implementation risks and
regulatory limitations); risk of development of our sales and
marketing capabilities; 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 liquidity and cash requirements and other cash needs,
at the times and in the amounts needed; risks related to the
outsourcing of certain 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 and associated costs, including patent
infringement, securities, business torts, 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.
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®, Sympazan® and the Aquestive logo are
registered trademarks of Aquestive Therapeutics, Inc.
Investor InquiriesICR WestwickeStephanie
CarringtonStephanie.carrington@westwicke.com646-277-1282
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