VANCOUVER, BC July 19, 2018 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”) is pleased to announce a recent expansion of the market opportunity for its reformulated anti-nausea transdermal patch, AQS1303, into the European market. Diclectin®, the oral reference product for AQS1303 for the treatment of nausea and vomiting of pregnancy, has recently received marketing authorization in the United Kingdom under the brand name Xonvea®. Aequus plans to launch AQS1303 in countries where an original oral form has been approved and an accelerated path to approval may exist for reformulated products. Previously, the focus had been on the United States and Canada, where Diclegis®/Diclectin® has been approved since 2013 and 1983, respectively. In those two markets alone, an estimated annual $200M USD market opportunity currently exists.
“The potential for our long acting anti-nausea transdermal patch to enter the European market following a UK approval of Diclectin is a very exciting development for this product,” said Anne Stevens, COO and Director of Aequus. “With over five million pregnancies in European countries every year, this is a significant market for us and we are delighted at the possibility of offering this easy to use alternative for women suffering from nausea and vomiting during their pregnancy.”
Following a review by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) in June 2018, Xonvea® is expected to be available in the UK later this year, followed by further filings for approval in additional European territories. These approvals would provide the basis for a regulatory approval via a hybrid (accelerated) route for Aequus’ anti-nausea patch in the European market.
Aequus is developing a long acting transdermal anti-nausea patch containing pyridoxine and doxylamine to provide patients with an easy to use alternative to the oral form, which would help alleviate the nausea and vomiting symptoms of pregnant women. Aequus will be pursuing partnership opportunities in the European countries following this advancement.
Aequus’ extended release transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®) currently used to treat nausea and vomiting of pregnancy. AQS1303 is designed to provide patients with a convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. According to IQVIA data, Diclegis® sales in the United States were approximately $186M USD for 2017.
Aequus has advanced AQS1303 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.
Based on FDA feedback, this product is expected to follow a Section 505(b)(2) New Drug Application, 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. Aequus would expect this product to follow a hybrid pathway in the European market, similar to the 505(b)2 pathway in the US.
ABOUT AEQUUS PHARMACEUTICALS INC.
Aequus Pharmaceuticals Inc. (TSX-V:AQS) (OTCQB:AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its pipeline to include several commercial products in ophthalmology and transplant, and a development stage pipeline in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. As a complement to its focus in neurology, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. 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. For further information, please visit www.aequuspharma.ca
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 include but are not limited to statements relating to: the further advancement of AQS1303, the regulatory requirements for AQS1303, and the Company’s ability to form strategic partnerships for its internal programs. 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: obtaining positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully outlicense or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with its manufacturer and other third parties will be maintained; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and technology offered by the Company’s competitors; and the Company’s ability to protect patents and proprietary rights. In evaluating forward looking statements, current and prospective shareholders should specifically consider various factors set out herein and 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.
Diclegis® and Diclectin® are registered trademarks of Duchesnay Inc.
Xonvea® is a registered trademark of Alliance Pharma plc