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Pharmanovia, the lifecycle management company, has today announced that it has entered into an exclusive licence and supply agreement with Aquestive Therapeutics, Inc. (NASDAQ: AQST) for its patented diazepam buccal film formulation across the EU, UK, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA)– up to 48 markets in total.
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. Pharmanovia will be responsible for seeking appropriate regulatory approval across EU and MENA.
Pharmanovia CEO, James Burt commented; “Pharmanovia and Aquestive are aligned in our mission to find new and innovative ways to enhance and revitalise iconic medicines. We have extensive experience with diazepam through the Valium® brand and, together with Aquestive’s unique PharmFilm® technology, we’re intending to bring a novel alternative diazepam delivery option to caregivers and patients at a time of critical need.”
Daniel Barber, Aquestive Therapeutics CEO, added: “Pharmanovia is experienced in bringing new products to market globally. They are a like-minded collaborator who share our passion and commitment to improving patient treatment and outcomes. Today’s announcement means we are one step closer to bringing a new alternative way to deliver an important treatment, that is convenient and precise to patients.”
Notes to editors.
2Source: NHS UK – https://www.nhs.uk/medicines/diazepam/about-diazepam/ – last accessed 26.9.22
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 26.9.2022.
For further information, please contact:
Alison Dyson, Director of Communications, Pharmanovia
07442 256310/ Alison.firstname.lastname@example.org
Or The PHA Group
Or ICR Westwicke
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 140 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 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 have 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 belongs to a group of medicines called benzodiazepines. It is used to treat anxiety, muscle spasms and seizures or fits.2
Epilepsy is a chronic noncommunicable disease of the brain that affects around 50 million people worldwide. It is characterized 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