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 it granted a license to
Zambon S.p.A. for the development and commercialization of Riluzole
Oral Film (ROF) in the European Union for the treatment of
amyotrophic lateral sclerosis (ALS). Zambon is a
multinational pharmaceutical company strongly committed to
innovating cure and care to make patients’ lives better, with a
focus on the central nervous system (CNS) therapeutic area.
ROF, utilizing Aquestive’s proprietary
PharmFilm® technology, is being developed for the treatment of ALS,
a debilitating disease affecting as many as 30,000 Americans1 and
52,000 Europeans2. Once approved, ROF may potentially fulfill
a critical need for ALS patients, given it can be administered
safely and easily, twice daily, without water. Development
initiatives conducted by Aquestive have included studies
demonstrating ROF's pharmacokinetic bioequivalence to the reference
listed drug, Rilutek®, as well as additional studies to assess
patients' ability to swallow ROF. The product is currently under
review by the U.S. Food and Drug Administration (FDA) for marketing
approval in the United States and has an anticipated PDUFA date of
November 30, 2019. ROF received FDA orphan drug designation
in January 2018.
“We are pleased to announce our collaboration
with Zambon to develop and commercialize ROF in the European Union.
Once approved, we believe that Riluzole, via our orally
administered dosage form, can bring meaningful and positive change
for the care of patients who are diagnosed with ALS and face
difficulties swallowing or administering traditional forms of
medication. It is important to us that patients in the
European Union have access to this medication. Zambon is well
positioned to commercialize this product in the EU given its
capabilities,” said Keith J. Kendall, Chief Executive
Officer of Aquestive.
“We are proud to announce that Zambon will
register and commercialize in the European Union Riluzole Oral
Film. Thanks to this collaboration with Aquestive, Zambon will
further strengthen its commitment to orphan diseases and to the CNS
area, enriching its portfolio with a new formulation that will
concretely help patients. Zambon is committed to improve people’s
quality of life through innovative medicines and modern therapeutic
solutions where they are mostly needed,” said Roberto
Tascione, CEO of Zambon S.p.A.
Under the terms of the license agreement, Zambon
will pay to Aquestive an undisclosed upfront payment for the
development and commercialization rights for ROF in the EU, along
with additional development and sales milestone payments and low
double digit royalties on net sales of the product in the EU.
Zambon will be responsible for the regulatory approval and
marketing of ROF in the EU and Aquestive will be responsible for
the development and manufacturing of the product.
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.
About Zambon S.p.A.Zambon is a
multinational pharmaceutical company that focuses on innovation and
development with the aim to improve patients' lives. Based on a
valuable heritage and strongly focused on the future, its goal is
to improve people's health through the development of innovative
and quality healthcare solutions.
Zambon products are commercialized in 87
countries. The company has 20 subsidiaries in three different
continents – Europe, America and Asia – and owns manufacturing
units in Italy, Switzerland, China and Brazil. The company today
has a strong focus on the treatment of rare diseases and
specialties, on top of respiratory, pain management and women's
care. Zambon was established in 1906 in Italy and today counts
2,500 employees all over the world. For further information, please
visit www.zambon.com
PharmFilm® and the Aquestive logo are registered
trademarks of Aquestive Therapeutics, Inc. All other
trademarks referenced herein are the property of their respective
owners.
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
Riluzole Oral Film and other product candidates; statements about
our growth and future financial and operating results and financial
position, ability to advance Riluzole Oral Film 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
or other governmental 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.
Company Contacts:
Aquestive TherapeuticsInvestor inquiries:
Stephanie Carringtonstephanie.carrington@icrinc.com646-277-1282
Media inquiriesMark Corbaemark.corbae@icrinc.com203-682-8288
ZambonValentina SaffiotiGlobal Head of Pharma
CommunicationPh. +39 02
66524508valentina.saffioti@zambongroup.com
1 Sources: CDC, “National Amyotrophic
Lateral Sclerosis (ALS) Registry FAQ”
https://wwwn.cdc.gov/als/alsfaq.aspx (Accessed January 2018), ALS
Association, “Quick Facts about ALS”
http://www.alsa.org/news/media/quick-facts.html (Accessed January
2018)
2 Sources: European Medicines Agency,
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192155
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