JERSEY CITY, N.J. and
WARREN, N.J., Jan. 21, 2021 /PRNewswire/ -- Mitsubishi Tanabe
Pharma America, Inc. (MTPA) and Aquestive Therapeutics, Inc.
(NASDAQ: AQST) today announced a licensing and supply deal for the
U.S. rights to commercialize EXSERVAN™ (riluzole),
an oral film formulation of riluzole for the treatment of
amyotrophic lateral sclerosis (ALS).
"Patients are always the central focus of our work as we try to
make a difference in their lives," said Atsushi Fujimoto, President, MTPA. "This
licensing deal will enable us to bring patients a riluzole oral
film designed to address the needs of people with ALS, including
those who have difficulties swallowing some medications. We are
honored to have this opportunity to expand our offerings to the ALS
community."
As a result of the deal, MTPA will commercialize EXSERVAN in the
U.S. Aquestive will serve as the exclusive sole manufacturer and
supplier for the product.
MTPA plans to make EXSERVAN available to patients in the
middle of 2021.
"As a company applying innovative technology to improve
medicines for patients, we are delighted to be working with a
world-leading innovator in ALS with a deep commitment to the
patient community," said Keith J.
Kendall, President and Chief Executive Officer of Aquestive.
"Mitsubishi Tanabe Pharma America is the right partner for
commercializing EXSERVAN oral film formulation of riluzole in
the United States."
Under the terms of the deal agreement, Aquestive will receive
upfront consideration, milestone payments, royalties on net sales
of EXSERVAN in the U.S., and will earn revenue pursuant to the
exclusive supply agreement.
About EXSERVAN™ (riluzole oral
film)
EXSERVAN, an oral film formulation of riluzole,
was developed by Aquestive using its PharmFilm®
innovative drug delivery technology. The oral film is placed on the
patient's tongue and quickly dissolves without the need for liquids
or food. RILUTEK® (riluzole) tablets was the
reference product during the oral film development. Oral film
riluzole was approved by the U.S. Food and Drug Administration
(FDA) in November 2019.
IMPORTANT SAFETY INFORMATION
EXSERVAN™ (riluzole) is
indicated for the treatment of amyotrophic lateral sclerosis
(ALS).
Do not use if you are allergic to riluzole or to any
of its ingredients.
Before using EXSERVAN, tell your healthcare provider about
all the medicines you take and all your health conditions,
including if you:
- Have hepatic (liver) impairment.
- Are taking strong or moderate CYP1A2 inhibitors such as
ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral
contraceptives, thiabendazole, vemurafenib, zileuton.
- Are pregnant or intend to become pregnant during EXSERVAN
therapy, or if you are breastfeeding or intend to breastfeed during
EXSERVAN therapy.
EXSERVAN can cause serious side effects, including:
- Hepatic Injury: Cases of drug-induced liver injury,
some fatal, have been reported in patients taking riluzole. Consult
your healthcare provider promptly if you experience unexplained
nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice
and/or dark urine.
- Neutropenia: Tell your healthcare provider if you
develop a fever while taking EXSERVAN.
- Interstitial Lung Disease: Tell your healthcare
provider if you have respiratory symptoms such as dry cough and
difficult or labored breathing. Discontinue EXSERVAN immediately if
interstitial lung disease develops.
The most common side effects include oral
hypoesthesia, asthenia, nausea, decreased lung function,
hypertension, and abdominal pain.
These are not all the possible side effects of EXSERVAN. Consult
your healthcare provider for medical advice about side effects and
if you have any side effect that bothers you or that does not go
away. To report SUSPECTED ADVERSE REACTIONS, contact Mitsubishi
Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Use EXSERVAN as prescribed. The recommended dosage for EXSERVAN
is 50 mg taken orally twice daily at least 1 hour before or 2 hours
after a meal. Place EXSERVAN oral film strip on the top of the
tongue where it will adhere and dissolve. Do not cut or split the
film or take liquids with EXSERVAN. Do not chew, spit, or talk
while EXSERVAN is dissolving.
About Mitsubishi Tanabe Pharma America, Inc.
Based in
Jersey City, N.J., Mitsubishi
Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of
Mitsubishi Tanabe Pharma Corporation's (MTPC) 100 percent owned
U.S. holding company, Mitsubishi Tanabe Pharma Holdings America,
Inc. It was established by MTPC to commercialize approved
pharmaceutical products in North
America. For more information, please visit
www.mt-pharma-america.com or follow us on Twitter,
Facebook and LinkedIn.
Overview of Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its
headquarters in Doshomachi, Osaka,
which is the birthplace of Japan's
pharmaceutical industry. With business centered on ethical
pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established
company with one of the longest histories of pharmaceutical
companies in Japan.1 In
accordance with the corporate philosophy of "contributing to the
healthier lives of people around the world through the creation of
pharmaceuticals," the Company formulated the key concept of Open Up
the Future under the Medium-Term Management Plan 2016-2020. Through
the discovery of drugs that address unmet medical needs, centered
on its priority disease areas — immune-inflammation diseases,
diabetes and kidney, central nervous system, and vaccines —
Mitsubishi Tanabe Pharma will strive to contribute to the health of
patients around the world. MTPC is the parent company of MTPA. For
more information, go to https://www.mt-pharma.co.jp/e/.
About Aquestive Therapeutics, Inc.
Aquestive
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), 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 Statement
This 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 include, but are not limited to,
statements regarding therapeutic benefits and plans and objectives
for advancing EXSERVAN to the market. These forward-looking
statements are also 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 Aquestive's 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; risk of delays in FDA
approval of our other drug candidates or failure to receive
approval; 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 royalty and other revenue streams of our
licensed products including EXSERVAN, achievement of royalty
targets worldwide or in any jurisdiction and certain other
commercial targets required for contingent payments under license
and monetization transactions, and of sufficiency of net proceeds
of these monetization and licensing transactions after satisfaction
of and compliance with our 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; 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.
Media Inquiries:
Debbie
Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com
Aquestive Investor Inquiries:
Westwicke, an ICR
Company
Stephanie Carrington
stephanie.carrington@westwicke.com
646-277-1282
1 Research by TOKYO SHOKO RESEARCH, LTD.
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