Aquestive Therapeutics Appoints Mark Lepore, MD, as Chief Medical Officer for Allergy
January 28 2021 - 7:30AM
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 announced the appointment of Mark Lepore, MD, as
the Chief Medical Officer for Allergy.
Dr. Lepore is a board-certified allergist and
pediatrician. He has over fourteen years of drug development
experience, including serving as Vice President, Head of Clinical
Strategy and Development for Inhalation and Complex Injectable
Products, and Vice President, Global Clinical Development, at Lupin
Pharmaceuticals, Inc., and previous clinical research roles in
respiratory therapeutics at Teva Pharmaceuticals. Prior to joining
industry, Dr. Lepore spent over a decade in private practice as an
allergy and asthma specialist and served as a clinical investigator
in over one hundred industry-sponsored trials. He received his
medical training at Thomas Jefferson University.
“I am very pleased to welcome Mark to the team,”
said Dan Barber, Chief Operating Officer of Aquestive. “His
background in allergy combined with his product development
experience are a great match for our programs focused within the
allergy space. This is an exciting time for Aquestive and, as we
continue to advance our pipeline in 2021, our epinephrine delivery
platform will be a key area of focus. Patients at risk for
anaphylaxis continue to have very limited treatment options except
for injectables. We believe that our platform has the potential to
change this dynamic and thereby reduce patients’ unmet needs. I
look forward to working with Mark as we continue to advance and
expand our product development pipeline. Mark will be an important
part of our planned R&D event highlighting our epinephrine
program during the third week of March.”
“Investing in talented and experienced product
development experts is an important building block for the company
in 2021,” said Keith Kendall, President and Chief Executive Officer
of Aquestive. “At the same time, we remain fully committed and
focused on the resubmission of our Libervant™ (diazepam) Buccal
Film application. We continue to interact with the FDA on Libervant
and they have indicated that we will receive their feedback in
writing in the coming weeks. We continue to believe that we will be
able to resubmit our NDA for Libervant shortly after receiving the
FDA’s written feedback.”
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® (clobazam) oral film, 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 other product
candidates through the regulatory and development pipeline; the
focus on growing the Company’s commercial sales of Sympazan®;
ability to 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
our drug candidate Libervant and AQST-108 and our other drug
candidates or failure to receive approval; ability to address the
concerns identified in the FDA’s Complete Response Letter dated
September 25, 2020 regarding the New Drug Application for
Libervant; risk of our ability to demonstrate to the FDA “clinical
superiority” within the meaning of the FDA regulations of 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
transaction, 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.carington@westwicke.com646-277-1282
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