pharmafile | March 30, 2023 | News story | Business Services  

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.”


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