Aquestive Therapeutics Provides Business Update
January 07 2021 - 07:30AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, today provided an update on recent developments in its
business.
“Given the progress on Libervant™ and AQST-108,
2021 will be an exciting and important year in the continued growth
of Aquestive and for the execution of our corporate, clinical and
commercial strategy,” said Keith J. Kendall, President and Chief
Executive Officer of Aquestive. “As we look ahead to 2021, our
focus will be on the advancement of Libervant and epinephrine
through our regulatory and development pipeline, as well as growing
our commercial sales of Sympazan® and continuing to manufacture
Suboxone® and other licensed products from our film manufacturing
capabilities.”
Key Highlights:
Libervant. As previously
announced, at a Type A meeting held on November 12, 2020, the U.S.
Food and Drug Administration (FDA) confirmed that the issues
identified in the Complete Response Letter (CRL) related to the New
Drug Application (NDA) for the Company’s drug candidate Libervant™
(diazepam) Buccal Film for management of seizure clusters may be
addressed by utilizing modeling and simulations based upon the
information provided by Aquestive in its FDA meeting package
submitted in October 2020. Key updates are:
- The Company resubmitted a revised
weight-based dosing regimen along with modeling and simulations in
December 2020.
- Based on correspondence from the
FDA, the Company expects to receive feedback and guidance from the
FDA in late January.
- The Company expects to resubmit the
NDA, based on further FDA feedback, during the first half of
2021.
Epinephrine. Utilizing
Aquestive’s PharmFilm® technologies, AQST-108 is a “first of its
kind” oral sublingual film formulation delivering systemic
epinephrine that is in development for the treatment of
anaphylaxis. Key updates are:
- Aquestive completed its second
Phase 1 pharmacokinetic (PK) trial in 24 healthy adult subjects,
which featured a 4-treatment crossover design comparing
pharmacokinetics, safety and pharmacodynamics of epinephrine
administered in a sublingual film to that of epinephrine
administered via both subcutaneous and intramuscular
injections.
- The data from multiple trials
demonstrate that AQST-108 can consistently deliver epinephrine
sublingually and all subjects had measurable plasma concentrations
of epinephrine.
- Based on top-line study results,
AQST-108 was generally well-tolerated, with adverse events observed
that are consistent with the known adverse events profile for
epinephrine.
- AQST-108 achieved a similar time to
maximal concentrations, or median Tmax, when compared to both the
subcutaneous and intramuscular injections of epinephrine.
- The Company plans on commencing
another PK trial in the first quarter of 2021 as it continues to
progress towards a final product formulation and dose.
“The topline data from the second PK study for
AQST-108 provides further evidence that we have developed a unique
technological solution that can deliver epinephrine through oral
administration,” said Mr. Kendall. “The study provides valuable
insight into how our technology works. In 2021, we will continue to
advance our program by conducting additional human studies as well
as working closely with the FDA. We look forward to providing more
insight on our technological solution at an R&D day to be
scheduled in the first quarter of 2021. Regarding our drug
candidate, Libervant, we look forward to receiving feedback from
the Agency and resubmitting our NDA as quickly as
possible.”
About Aquestive
TherapeuticsAquestive Therapeutics is a pharmaceutical
company that applies innovative technology to solve therapeutic
problems and improve medicines for patients. The Company has
commercialized one internally-developed proprietary product to
date, Sympazan, has a commercial proprietary product pipeline
focused on the treatment of diseases of the central nervous system,
or CNS, and other unmet needs, and is developing orally
administered complex molecules to 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
StatementsCertain statements in this press release are
“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 of Libervant and AQST-108
through the regulatory and development pipeline; the focus on
growing the Company’s commercial sales of Sympazan® and continuing
to manufacture Suboxone® and other licensed products; ability to
address the concerns identified in the FDA’s Complete Response
Letter dated September 25, 2020 regarding the New Drug Application
for Libervant and obtain FDA approval of Libervant for U.S. market
access; clinical trial timing and plans for AQST-108; 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 and plans for AQST-108
and our other drug candidates; risk of delays in FDA approval of
Libervant and AQST-108 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 the
royalty and other revenue stream of the KYNMOBI monetization,
achievement of royalty targets worldwide or in any jurisdiction and
certain other commercial targets required for contingent payments
under the monetization transaction, and of sufficiency of net
proceeds of the monetization transaction after satisfaction of and
compliance with 12.5% Senior Notes obligations, as applicable, and
for funding the Company’s operations; 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; 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; 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 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®, Sympazan® 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:Westwicke, an ICR
CompanyStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
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