Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty
pharmaceutical company focused on developing and commercializing
differentiated products that meet patients’ unmet needs and solve
therapeutic problems, today announced that data from five
abstracts, including two “late-breakers”, related to its
therapeutic candidate, Libervant™ (diazepam) Buccal Film, will be
presented at the American Epilepsy Society (AES) 2019 Annual
Meeting, taking place December 6-10, 2019 in Baltimore.
In addition to the poster presentations,
Aquestive will host a Scientific Exhibit on Monday, December 9th
from 8:00 am – 11:00 am ET at the Baltimore Convention Center in
Rooms 318-319, Level 300. Study investigators and authors will be
present to discuss the posters in more detail and answer
questions.
Below is an overview of the poster
presentations:
Title: Pharmacokinetics of
Diazepam Buccal Film in Adult Patients with Epilepsy: Comparison
with Diazepam Rectal Gel Poster Number:
1.432Presenter: Michael A. Rogawski, MD, PhD,
Professor of Neurology and Pharmacology, School of Medicine,
University of California, DavisDate/Time:
Saturday, December 7, 12 pm – 2 pm ETLocation:
Hall E, Level 100
Title: Patient and Caregiver
Preference for Route of Administration of a Benzodiazepine for
Control of Increased Seizure Activity in Stable Patients
Poster Number: 2.129 Presenter:
Ahmed Abdel-Razek, MD, Head of Medical Affairs, Aquestive
TherapeuticsDate/Time: Sunday, December 8, 12 pm –
2 pm ETLocation: Hall E, Level 100
Title: Unreliable Absorption with Rectal
Administration of DiazepamPoster Number:
2.258Presenter: Gary Slatko, MD, Chief Medical
Officer, Aquestive TherapeuticsDate/Time: Sunday,
December 8, 12 pm – 2 pm ETLocation: Hall E, Level
100
Title: Simulation of the
Pharmacokinetics of Diazepam Buccal Film in Adult Patients with
Epilepsy with Weight-adjusted Dosing Poster
number: 3.304Presenter: Allen H. Heller,
MD, MPH, Pharma Study Design LLCDate/Time: Monday,
December 9, 12 pm – 1:45 pm ETLocation: Hall E,
Level 100
Title: Safety and Tolerability
Associated with Chronic Intermittent Use of Diazepam Buccal Film in
Pediatric, Adolescent, and Adult Patients with
EpilepsyPoster Number:
3.444Presenter: Syndi Seinfeld, DO, MS, Associate
Professor, Virginia Commonwealth
UniversityDate/Time: Monday, December 9, 12 pm –
1:45 pm ETLocation: Hall E, Level 100
The posters will be accessible on
the Newsroom section of the Aquestive website on the day of
the presentations (Link).
Details of the Company’s Investor &
Analyst Libervant™ Update Forum and webcast are as
follows:Date/Time: Monday, December 9
from 4:00 pm ET – 5:30 pm ETWebcast and
Presentation: The Investor & Analyst
Libervant™ Update Forum will be webcast live and can be
accessed from "Events and Presentations" in the Investors section
of Aquestive's website (Link) on the day of the
event.Registration: In order to attend in person,
please contact Stephanie Carrington at
stephanie.carrington@icrinc.com.
About LibervantLibervant is a
buccally, or inside of the cheek, administered soluble film
formulation of diazepam, a benzodiazepine intended for rapid
treatment of acute uncontrolled seizures in selected, refractory
patients with epilepsy on stable regimens of AEDs who require
intermittent use of diazepam to control bouts of increased seizure
activity. Aquestive is developing Libervant as an alternative to
Diastat (diazepam rectal gel), the current standard of care rescue
therapy for patients with refractory epilepsy, which as a rectal
gel, is invasive, inconvenient, and difficult to administer.
Libervant has received orphan drug designation from the FDA.
Aquestive expects to complete its rolling NDA submission for
Libervant around the end of November 2019.
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. Aquestive has received
conditional acceptance of the use of the trade name Libervant,
which is subject to final FDA review and acceptance.
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 and plans and objectives for regulatory approval of
Libervant and other product candidates; statements about our growth
and future financial and operating results and financial position,
ability to advance Libervant and our other product candidates to
the market, 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
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
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