WARREN, N.J., Dec. 20, 2018 /PRNewswire/ -- Aquestive
Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company pharmaceutical company focused on identifying, developing,
and commercializing differentiated products to solve therapeutic problems, is reporting positive developments across its
business.
Sympazan™ Launch Propels Aquestive's First Proprietary Franchise
In November 2018, the company received approval from the U.S. Food and Drug Administration (FDA)
for its first proprietary commercial product, Sympazan™, for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Key pharmacokinetic (PK) data has been published in
Epilepsia and presented at the American Epilepsy Society 2018 Annual Meeting in early December.
With the product now in channel, sales and marketing plans are being executed to activate customer demand and new
prescriptions. Aquestive's commercial team of 50+ experienced professionals have already completed thousands of interactions with
local healthcare providers, payers that cover approximately 280 million lives, and pharmacists in markets nationwide. The company
has also scheduled more than 40 speaker programs through February 2019. Important information for
physicians is available at https://sympazanhcp.com, where healthcare professionals can access educational resources, request PharmFilm®
samples, and download copay cards that can assist LGS families.
"The first scripts have been written and filled. We are very encouraged by the reception of Sympazan in the market and feel
that our engagements with customers are positioning us well for the future launch of Libervant™, when approved,"
said Ken Marshall, Chief Commercial Officer of Aquestive Therapeutics. "We look forward to
building on our momentum in 2019."
Regulatory Filings Are Advancing for Libervant™ and Exservan™ in 2019
Aquestive is developing diazepam buccal film (DBF or Libervant™) for the treatment of seizure clusters in
patients with refractory epilepsy. The company recently held a pre-NDA (New Drug Application) meeting with the FDA to review data
and pharmacokinetic models generated thus far from multiple clinical studies. Based on the FDA's feedback, the company is
planning to complete a single-dose, crossover study in a small number of epilepsy patients comparing DBF and Diastat dosing and,
in parallel, advance plans for filing an NDA in 2019.
"We are pleased with the feedback given by the FDA. We'll develop the additional data as quickly as possible, and we have a
clear path to submission and approval," said Keith J. Kendall, Chief Executive Officer of
Aquestive Therapeutics. "Patients suffering from seizure clusters have been waiting a long time for an alternative to the current
treatments available, and we are excited to bring these patients a medication that is fast-acting and easy to administer. Based
on our data, we believe Libervant has the potential to significantly improve patient outcomes."
Libervant is a novel formulation of diazepam as a small, thin film strip for placement inside the cheek. Libervant leverages
Aquestive's proprietary PharmFilm® technology and is in development for the management of select patients with
refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity or seizure
clusters. Currently, the only product with FDA-approval for treatment is Diastat, a rectally-applied gel.
Aquestive is also planning to submit an NDA in January 2019 for riluzole oral film (ROF or
Exservan™). The company recently completed a swallowing safety study after receiving the FDA's permission to shorten
the study. The primary objective of the study was to evaluate the effect, if any, of investigational ROF on swallowing safety in
subjects with amyotrophic lateral sclerosis (ALS). The study successfully met its primary endpoint and showed that Exservan has
no adverse effect on swallowing safety in subjects with ALS.
Legal Proceedings and New Drivers of Suboxone® Film Business
Aquestive and Indivior PLC (LON: INDV) are filing a petition with the U.S. Court of Appeals for the Federal Circuit (CAFC) for
a rehearing by the original panel of judges, as well as a rehearing en banc, on the CAFC's ruling to vacate the
preliminary injunction (PI) granted by the U.S. District Court of New Jersey to enjoin Dr.
Reddy's Laboratories ("DRL") from launching its generic buprenorphine/naloxone sublingual film product, which utilizes
Aquestive's PharmFilm® technology. The PI will remain in place to enjoin DRL's "at-risk" entry into the U.S. market,
until the CAFC rules on the joint petition. This decision will have no impact on the core Aquestive patent portfolio.
"We will continue to work with Indivior to assert and protect our intellectual property embedded in SUBOXONE®
Sublingual Film against at-risk generic entrants," said Mr. Kendall. "This will continue to be a significant source of revenue
for Aquestive for the foreseeable future."
Aquestive's Suboxone revenues are driven by order volume from both branded and authorized generic products. Aquestive has a
sole and exclusive worldwide manufacturing agreement with Indivior for both branded and authorized generic Suboxone and will
continue to fulfill non-U.S. orders, which also continue to grow as a percent of total Suboxone business.
Early Asset Pipeline Progressing
Several proprietary assets in early stages of development show promise for clinical advancement in 2019. Aquestive is
continuing to optimize the formulations and advance proof-of-concept studies for AQST-108 (epinephrine) and AQST-305
(octreotide). Interactions with U.S. and ex-U.S. regulatory authorities and potential study investigators have provided valuable
input into plans for clinical development. Additional clinical trials for both products will take place in 2019.
Solid Cash Position and Access to Non-Dilutive Capital Sources
Aquestive expects full-year 2018 revenues to be more than $67 million and expects to end 2018
with cash and cash equivalents in the range of $58 million to $60
million. The company plans to provide full year 2019 guidance in conjunction with the
year-end conference call in March 2019.
"With the cash we have on-hand, along with cash generated by our ongoing business, and additional options to monetize
non-strategic, partnered product royalty streams, we have the resources we need to fulfill our business plans," said Mr.
Kendall.
Investment Community Conference Call
The company will host an investment community conference call at 8:00 a.m. ET on Thursday, December 20,
2018. Investors and analysts may participate in the conference call by dialing (866) 417-5886 from the U.S. and (409)
217-8235 internationally, followed by the conference ID: 3376049. There will also be a simultaneous, live webcast available on
the Investors section of the company's website at https://investors.aquestive.com/events-and-presentations. The webcast will be archived for 30 days.
About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and
commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage
proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex
molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing
and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with
pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.
SYMPAZAN IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are
inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
CONTRAINDICATIONS
SYMPAZAN is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity
reactions have included serious dermatological reactions.
WARNINGS AND PRECAUTIONS
Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants SYMPAZAN has a CNS depressant effect.
Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS
depressants or alcohol may be potentiated.
Somnolence or Sedation
SYMPAZAN causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish
with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS
depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous
machinery or motor vehicles, until the effect of SYMPAZAN is known.
Withdrawal Symptoms
Abrupt discontinuation of SYMPAZAN should be avoided. The risk of withdrawal symptoms is greater with higher doses. Withdraw
SYMPAZAN gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus.
Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with
clobazam in both children and adults. Discontinue SYMPAZAN at the first sign of rash, unless the rash is clearly not
drug-related.
Physical and Psychological Dependence
Patients with a history of substance abuse should be under careful surveillance when receiving SYMPAZAN.
Suicidal Behavior and Ideation
AEDs, including SYMPAZAN, increase the risk of suicidal thoughts or behavior in patients. Patients treated with SYMPAZAN should
be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or
behavior. Inform patients, their caregivers, and families of the increased risk of suicidal thoughts and behaviors. Advise them
to be alert for and report immediately to healthcare providers any emergence or worsening signs and symptoms of depression, any
unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.
ADVERSE REACTIONS
Adverse reactions (?10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and
drooling.
DRUG INTERACTIONS
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of
concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation. Concomitant
use of SYMPAZAN with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients
and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol
may be potentiated.
Hormonal contraceptives that are metabolized by CYP3A4; effectiveness may be diminished when given with SYMPAZAN. Additional
non-hormonal forms of contraception are recommended when using SYMPAZAN. Dose adjustment may be necessary of drugs metabolized by
CYP2D6 and of SYMPAZAN when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine).
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation: SYMPAZAN may cause fetal harm and should only be used during pregnancy if the potential benefit
justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of
pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. SYMPAZAN is excreted in
human milk. Because of the potential for serious adverse reactions in nursing infants from SYMPAZAN, discontinue nursing or
discontinue the drug. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit
http://www.aedpregnancyregistry.org/.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here to see full Prescribing Information, including Boxed Warning.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential,"
"project," "will," "would," or the negative of those terms, and similar expressions, are intended to identify forward-looking
statements. Such statements include, but are not limited to, statements about regulatory approvals and pathways, clinical trial
timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, business
strategies, market opportunities, financing, 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; the risks of delays
in FDA approval of our drug candidates or failure to receive approval; the risks inherent in commercializing a new product
(including technology risks, financial risks, market risks and implementation risks and regulatory limitations); development of
our sales and marketing capabilities; the rate and degree of market acceptance of our product candidates; the success of any
competing products; the size and growth of our product markets; the effectiveness and safety of our product candidates; risks
associated with intellectual property rights and infringement; unexpected patent developments; and other risks and uncertainties
affecting the Company including those described in the "Risk Factors" section included in our Registration Statement on Form S-1
declared effective by the SEC on July 24, 2018. As with any pharmaceutical product candidate under
development, there are significant risks with respect to the development, regulatory approval and commercialization of new
products. 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. We assume no obligation to update our forward-looking statements after
the date of this press release whether as a result of new information, future events or otherwise, except as may be required
under applicable law.
Media inquiries:
Christopher Hippolyte
christopher.hippolyte@syneoshealth.com
212-364-0458
Investor inquiries:
Stephanie Carrington
stephanie.carrington@icrinc.com
646-277-1282
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SOURCE Aquestive Therapeutics, Inc.