29th March 2023

Pharmanovia expands exclusive licensing collaboration with Aquestive Therapeutics

For Trade, Business and Medical Media only

Basildon, UK – For immediate release, 27 March 2023

Pharmanovia, a global pharmaceutical company that revitalises, extends and expands the lifecycle of established medicines, has today announced that it has expanded its exclusive licence and supply agreement with Aquestive Therapeutics, Inc. (NASDAQ: AQST) for its patented diazepam buccal film formulation to cover rest of the world, excluding US, Canada and China.

Aquestive Therapeutics has been granted tentative approval by the US Food and Drug Administration (FDA)1, for its diazepam buccal film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. In addition to EU and MENA, for which Pharmanovia entered an exclusive licence in September 2022, Pharmanovia will be responsible for seeking appropriate regulatory approval in the expanded territories, which includes Latin America, Africa and Asia Pacific.

Pharmanovia CEO, James Burt, commented; “Following a strong start to our collaboration with Aquestive Therapeutics, we’ve expanded our agreement to include many more territories. Our experience with an established brand in Valium®, combined with Aquestive Therapeutic’s unique PharmFilm® technology, provides a potentially significant delivery option to caregivers and patients in times of critical need and enables us to optimise an existing medicine to better meet the needs of patients, healthcare professionals and payors.”

Daniel Barber, Aquestive Therapeutics CEO, added: “Having worked closely with Pharmanovia over the past few months following our initial licence and supply agreement, it’s clear that Pharmanovia’s experience makes them the right collaborator across an expanded geographic footprint. Patient access to our diazepam buccal film on a global basis remains an important initiative for us.”

Notes to editors

1https://aquestive.com/aquestive-therapeutics-receives-fda-tentative-approval-for-libervant-diazepam-buccal-film/ –  last accessed 24.03.2023

2Source: NHS UK – https://www.nhs.uk/medicines/diazepam/about-diazepam/ – last accessed 24.03.2023

3Source WHO https://www.who.int/news-room/fact-sheets/detail/epilepsy#:~:text=Globally%2C%20an%20estimated%205%20million,as%20139%20per%20100%20000.Last accessed 24.03.2023

For further information, please contact:

Alison Dyson, Director of Communications, Pharmanovia

07442 256310/ communications@pharmanovia.com

Or pharmanovia@67health.co.uk

Or ICR Westwicke (for Aquestive Therapeutics, Inc.)
Stephanie Carrington
Stephanie.carrington@westwicke.com

001-646-277-1282

About Pharmanovia

Pharmanovia is a global lifecycle management healthcare company. Our mission is to revitalise iconic medicines for the benefit of patients, prescribers and payors, and utilise our capabilities to launch novel therapies.

With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Oncology, Endocrinology, Neurology and Cardiovascular.

About Aquestive Therapeutics, Inc.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to solve patients’ problems with current standard of care and provide transformative products to improve their lives. Aquestive Therapeutics is developing orally administered products to deliver complex molecules providing novel alternatives to invasive and inconvenient standard of care therapies.

About the treatment option

Pharmanovia is licensing in the rights to diazepam buccal film, a small film that is easily administered to the inside of the cheek, to deliver diazepam more precisely through the oral mucosa to treat convulsive seizures in patients with epilepsy. 

Aquestive Therapeutics has developed the diazepam formulation, which is absorbed directly through the buccal mucosa, using the patented PharmFilm® technology. The buccal mucosa’s wide, relatively immobile, and highly permeable surface area provided the stable and controlled microenvironment needed to optimise adhesion, absorption, and onset of action.

Diazepam

Diazepam belongs to a group of medicines called benzodiazepines. It is used to treat anxiety, muscle spasms and seizures or fits.2

About Epilepsy

Epilepsy is a chronic noncommunicable disease of the brain that affects around 50 million people worldwide. It is characterised by recurrent seizures, which are brief episodes of involuntary movement that may involve a part of the body (partial) or the entire body (generalised) and are sometimes accompanied by loss of consciousness.

Seizure episodes are a result of excessive electrical discharges in a group of brain cells. Different parts of the brain can be the site of such discharges. Seizures can vary from the briefest lapses of attention or muscle jerks to severe and prolonged convulsions. Seizures can also vary in frequency, from less than one per year to several per day.3

COR2023SOC007 March 2023