Vancouver, BC. July 29, 2016 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has filed an international patent application with the US Patent & Trademark Office (USPTO) that covers transdermal extended-release formulations of clobazam, relating to the Company’s AQS1302 program. This is the conversion of a provisional application which was filed on August 17, 2015. Aequus owns the world-wide rights to the formulations described in the patent application.
AQS1302 is being developed as an alternative to currently available oral clobazam. Clobazam is used for the treatment of epilepsy globally, with the exception of the US where it is approved specifically for a severe form of epilepsy, Lennox-Gastaut Syndrome (LGS). Clobazam is also used for the treatment of anxiety in European and Latin American countries. In 2015, US sales of oral clobazam (Onfi ®) reached $370 million USD, based on US IMS data. The currently available oral form of this medication is dosed twice daily and can be challenging for a caregiver to administer, particularly in patients with severe, debilitating epilepsies such as LGS where difficulty swallowing and feeding tubes are common. AQS1302 is expected to relieve this burden on patients and caregivers with its easy-to-administer transdermal patch design.
The AQS1302 transdermal clobazam patch is being developed in both once-daily and once-weekly forms, and is expected to reduce the daily pill burden and subsequent risk of breakthrough seizures due to missed doses. Transdermal delivery also allows for steady-state medication delivery and avoidance of first-pass metabolism, which has the potential to reduce certain gastrointestinal side-effects including constipation, vomiting and trouble swallowing.
This patent application is part of the Company’s growing intellectual property portfolio, which includes a patent for the transdermal formulation of aripiprazole that has been issued / allowed in five major countries or regions, including the US, Russia, Mexico, Japan and Australia, and pending in multiple additional territories. Aequus also expects to convert an additional provisional patent application for the Company’s third transdermal development program, a treatment for use in nausea and vomiting of pregnancy, in the near term.
“We are delighted to see our clobazam program advance in its development and one step closer to providing those in need of this medication with an easy to use and convenient dosage form,” said Doug Janzen, Chairman and CEO of Aequus. “Further, this adds to Aequus’ growing patent estate, and combined with the world-wide rights to our internal development programs, will provide us with an opportunity to add significant shareholder value in the near term.”
Lennox Gastaut Syndrome is a rare, severe epilepsy syndrome, accounting for 2-5% of all childhood epilepsy. LGS is characterized by frequent and multiple seizure types – with patients experiencing 7 seizures per day, on average. One of the severe seizure types patients with LGS experience are ”˜drop attacks’: sudden, complete losses of posture involving a fall of either the head only or the whole body. About one- to two-thirds of LGS patients have drop attacks, which typically last less than 15 seconds. The majority of LGS patients (91%) have some mental retardation and ~22% require a feeding tube or have difficulty swallowing (dysphagia).
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. www.aequuspharma.ca.