Aquestive Therapeutics Licenses Sympazan® (clobazam) Oral Film to Assertio Holdings, Inc.
28 October 2022 - 12:05AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company advancing current standards of care to solve patients’
problems through simplifying complex delivery methods, announced
today a transaction to license Sympazan® (clobazam) oral film to
Otter Pharmaceuticals, LLC, a subsidiary of Assertio Holdings, Inc.
(“Assertio”) (NASDAQ: ASRT), a specialty pharmaceutical company
offering differentiated products to patients. Sympazan (clobazam)
oral film is for the adjunctive treatment of seizures associated
with Lennox‐Gastaut Syndrome (LGS) in patients aged two years of
age or older.
“The completion of this transaction marks the
beginning of a new chapter for Aquestive, and we are thrilled that
Assertio recognizes Sympazan’s significant growth opportunities,”
remarked Daniel Barber, Chief Executive Officer of Aquestive. “This
agreement for Sympazan is another example of a non-dilutive
financing option that allows us to continue focusing our efforts on
the development of AQST-109 (epinephrine sublingual film), to meet
the needs of patients who need an alternative emergency treatment
of severe allergic reactions, including anaphylaxis. Our commercial
expertise will now be able to focus on the potential launch of
AQST-109, if approved by the FDA.”
Under the terms of the definitive agreement,
Aquestive exclusively licensed the product’s intellectual property
to Assertio for an upfront payment of $9.0 million. Aquestive also
entered into a long-term supply agreement with Assertio for
Sympazan. Under the terms of the agreement, Aquestive will continue
to prosecute an existing patent application that could extend
patent coverage for Sympazan to as late as 2039. Upon the patent
allowance for Sympazan, Aquestive will receive a $6.0 million
milestone payment and royalties from Assertio.
About Aquestive
Aquestive Therapeutics, Inc. (NASDAQ: AQST)
is a pharmaceutical company advancing current standards of care to
solve patients’ problems through simplifying complex delivery
methods. We are developing orally administered products to deliver
complex molecules, providing novel alternatives to invasive and
inconvenient standard of care therapies. Aquestive has five
commercialized products on the U.S. market, four licensed products
and one stand-alone proprietary product to date, Sympazan®
(clobazam) oral film for the treatment of seizures associated with
Lennox-Gastaut syndrome. Our licensees market their products in
the U.S. and around the world. 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. Aquestive is advancing a late-stage proprietary
product pipeline focused on treating diseases of the central
nervous system, or CNS, and an earlier stage pipeline for the
treatment of severe allergic reactions, including anaphylaxis. For
more information, visit Aquestive.com and follow us on
LinkedIn.
Forward-Looking Statement
Certain 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 potential allowance of a patent
application that would extend patent coverage of Sympazan to as
late as 2039, and related milestone payments, the advancement 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, risk
that the additional patent application filed for Sympazan will not
be allowed by the U.S. Patent and Trademark Office, and there can
be no assurance that we will be successful in obtaining such
allowance, and risk of delays related to the allowance of such
patent application; 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 in
FDA approval of Libervant® (diazepam) Buccal Film, AQST-109, and
our other drug candidates or failure to receive FDA approval; risk
of our ability to demonstrate to the FDA “clinical superiority”
within the meaning of the FDA regulations of Libervant relative to
a FDA-approved nasal spray product of a 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 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 Inquiries:ICR Westwicke Stephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
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