Aequus Pharmaceuticals Obtains Health Canada Approval

Aequus Pharmaceuticals Inc. (TSXV: AQS) is initiating a Proof of Concept clinical trial of its anti-nausea patch

SmallCapPower | July 6, 2017: Aequus Pharmaceuticals Inc. (TSXV: AQS), a specialty pharmaceutical company focused on developing and commercializing differentiated products for unmet medical needs, announced on July 4, 2017, that it has received Health Canada approval for initiating a Proof of Concept clinical trial for its pipeline product AQS1303, a long-acting transdermal anti-nausea patch containing combination of pyridoxine and doxylamine, the active ingredients in the approved oral version Diclegis marketed by Duchesnay USA. The single-dose cross-over comparative bioavailability study versus the oral version of the drug Diclegis in nine healthy volunteers will be completed by the end of 2Q17. Concurrently Aequus is preparing for a pre-Investigational New Drug meeting with the U.S. FDA and plans to follow a 505(b)(2) pathway, an abbreviated clinical pathway that allows the Company to reference safety and efficacy data of the original oral tablet form of the medication.

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This is the second proof of concept study for the Company’s four development pipeline products, which are all transdermal formulations of drugs. AQS1301, once-weekly transdermal formulation of aripiprazole, successfully completed Two Proof of Concept clinical studies and is due for a Pre-IND meeting for potential approval in the U.S. The Company currently markets two (TACROLIMUS IR and VISTITAN) products in Canada and has two Epilepsy products in pre-registration stage in Canada.

Nausea and Vomiting of Pregnancy (NVP), most commonly known as “morning sickness,” affects ~53% of women and Pyridoxine/doxylamine currently marketed as Diclegis® (US)/Diclecitin® (Canada) is the first-line therapy and the only on-label intervention for this indication. However this oral form needs to be dosed up to four times per day, causing gag reflexes in women. Hence there is a large and unmet need for an alternative delivery system. If approved, Aequus’ transversal could capture a sizable portion of the oral Diclegis market, which the Company estimates at $120 million in 2015. Aequus reported ~$0.7 million revenues for 2016 and the approval of the AQS1301 and the AQS1303 products could drive revenues going forward. The Company currently trades at price to ttm sales of ~18.24x compared to the pharmaceutical industry average of ~4.0x.

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