Pipeline

An expanding portfolio

Aquestive Therapeutics is the undisputed leader in developing and delivering medications via film, through PharmFilm® technology. Building on this success, we have established a robust portfolio of treatments for CNS disorders and are advancing a late-stage pipeline with promising treatments for complex conditions.

Reinventing medicines

Our investigational medicines can offer simple new ways for patients and caregivers to use proven and trusted molecules. Our late-stage pipeline includes several investigational treatments for CNS conditions, where patients face great difficulty in using medication because of the impact of their disease.¹ Looking ahead, we see even greater potential for PharmFilm® technology to improve patient treatment and are working to deliver complex molecules, proteins, and peptides on oral film with newer prodrugs and technologies.

Product Pipeline

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Program

Molecule

Indication

Formulation Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Marketed

CNS Programs

SYMPAZAN®

clobazam

Lennox-Gastaut syndrome

Marketed

Indicated to treat Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

Status

Received FDA approval, November 1, 2018

Highlights

First and only film formulation of clobazam
Addresses dosing challenges associated with tablets and oral formulations of clobazam
For more information, visit www.sympazan.com or download the Prescribing Information

Libervant^TM*

diazepam^†

Breakthrough Seizures

Phase 3

In development as an oral rescue therapy for breakthrough seizures

Status

Phase 3

Highlights

Diazepam buccal film may address issues of invasiveness and consistency of absorption, with current standard of care — DIASTAT® (diazepam rectal gel)

Exservan^TM*

riluzole^†

ALS

Filed

In development as a treatment for amyotrophic lateral sclerosis (ALS)

Status

Filed

Highlights

Dysphagia affects many people with ALS type 1
Exservan^TM may improve the ability of sufferers to use riluzole, proven to extend life and time to tracheotomy

Complex Molecule Programs

AQST-108

epinephrine^†

Anaphylaxis, severe allergy

Phase 1

In development as a treatment for anaphylaxis, severe allergy

Status

Phase 1

Highlights

Anaphylaxis may impact as many as 1 in 20 people in the United States^2-4
Potential to be the first oral version of epinephrine available as a therapeutic solution for anaphylaxis

AQST-305

octreotide^†

Acromegaly / Carcinoid syndrome

Pre-Clinical

In development as a treatment for patients with acromegaly and neuroendocrine tumors

Status

Pre-Clinical, proof of concept clinical studies in progress

Highlight

Potential to decrease or possibly eliminate the burden associated with monthly depot intramuscular injections of octreotide

Licensed programs

SUBOXONE
(Partner: Indivior)

buprenorphine / naloxone

Opioid Dependence

Marketed since 2010

Indicated to treat opioid dependency

Status

Marketed since 2010

Highlights

Market leader for the treatment of opioid dependency
For more information, visit www.suboxone.com or download the Prescribing Information

ZUPLENZ
(Partner: Midatech)

ondansetron

CINV / PINV

Marketed since 2010

Anti-emetic treatment for patients receiving chemotherapy, radiation therapy, or surgery

Status

Marketed since 2010

Highlights

Provides an alternative for people who have difficulty swallowing
For more information, visit www.zuplenz.com or download the Prescribing Information

APL-130277
(Partner: Sunovion)

apomorphine^†

Parkinson’s Disease

Filed

In development as a treatment for Parkinson’s disease

Status

Filed

Highlight

Potential to provide an alternate delivery method for patients with loss of body movement

AQST-119
(Partner: IntelGenx)

tadalafil^†

Erectile Dysfunction / BPH

Filed

In development as a therapy for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia

Status

Filed

Highlight

Potential to provide an alternate delivery method for those with erectile dysfunction

*Aquestive has received conditional acceptance of the use of this trade name for its buccal diazepam and riluzole oral film product and is subject to final FDA review and acceptance

^†Subject to review, evaluation, and approval of the FDA

Essential information for the investment community

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Aquestive sponsored clinical trials

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Clinical trial news and other updates

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References

1. Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747–753.

2. Fischer D, Vander Leek TK, Ellis AK, Kim H. Anaphylaxis. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):54

3. Wood RA, Camargo CA Jr, Lieberman P, et al. Anaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United States. J Allergy Clin Immunol. 2014 Feb;133(2):461-467.

4. Ma L, Danoff TM, Borish L. Case fatality and population mortality associated with anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(4):1075-1083.

Sympazan® is a registered trademark of Aquestive Therapeutics, Inc.
SUBOXONE® is a registered trademark of Indivior UK Ltd.
ZUPLENZ® is a registered trademark of Midatech Pharma US Inc.
DIASTAT® is a registered trademark of Bausch Health Companies, Inc.

Pipeline

An expanding portfolio

Reinventing medicines

Product Pipeline

Essential information for the investment community

Aquestive sponsored clinical trials

Clinical trial news and other updates

References

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