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Aequus and Camargo Prepare for Meeting with FDA

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molee   Wednesday, 01/31/18 09:33:27 AM
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Aequus and Camargo Prepare for Meeting with FDA to Advance Anti-Nausea Patch

VANCOUVER, BC--(Marketwired - January 31, 2018) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today announced plans to advance its transdermal patch for pregnancy-related anti-nausea, AQS1303, following positive results from the proof of concept study completed in 2017. The Company will work with its regulatory and strategic consulting partner, Camargo Pharmaceutical Services, LLC ("Camargo"), to prepare for a pre-Investigational New Drug Application ("pre-IND") meeting with the US Food and Drug Administration ("FDA") to define the clinical strategy for approval in the United States. The Company anticipates pursuing an abbreviated 505(b)(2) pathway.

"We feel very strongly about the need for this program and are delighted to see its continued progress," said Anne Stevens, COO and Director of Aequus. "We expect a meeting with the FDA in the second quarter of this year and anticipate it will provide clarity on the requirements for AQS1303 in order to achieve FDA approval under 505(b)(2)."

AQS1303 is a long-acting transdermal patch intended for the treatment of nausea and vomiting of pregnancy ("NVP"). AQS1303 would provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. Currently, the oral form of Diclegis® is the only FDA-approved medication for morning sickness in pregnant women and in 2015 reached sales in the United States of approximately U.S.$120 million, according to IMS data. It is estimated that 70% of women experience NVP, and in some severe cases it may persist throughout their entire pregnancy, having a significant impact on expectant mothers' quality of life. A long-acting transdermal form of pyridoxine/doxylamine is being developed by Aequus to address the risk of missed doses due to emesis (vomiting) and to provide consistent and sustained symptomatic relief.

Aequus owns global rights to this program.

ABOUT AQS1303

Aequus has advanced the multi-day transdermal patch, AQS1303, containing the combination of pyridoxine hydrochloride and doxylamine succinate (the active ingredients in Diclegis®/Diclectin®) through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.

This product is expected to follow a Section 505(b)(2) New Drug Application (NDA), an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.

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