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).
ABOUT AEQUUS PHARMACEUTICALS
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.
Aequus Investor Relations
This release may contain forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this release include but are not limited to statements relating to: the expected benefits of AQS1302 and transdermal delivery, the conversion of an additional provision patent application for the Company’s third transdermal development program, the ability of the Company to add significant shareholder value in the near term, and the Company’s intention to commercialize its internal programs in Canada, form strategic partnerships and build its Canadian commercial platform. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward-looking statements included in this release, the Company has made various material assumptions, including, but not limited to general business and economic conditions, the Company’s ability to protect its intellectual property, the Company’s ability to raise additional funding, existing governmental regulations and changes in, or the failure to comply with, governmental regulations, changes in business strategy or development plans, the expected benefits of AQS1302 and transdermal delivery and the ability of the Company to convert an additional provisional patent application for the Company’s third transdermal development program. In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors set out under the heading “Risk Factors” in the Company’s Annual Information Form dated April 29, 2016, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements.