Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), 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 doxylamine succinate and pyridoxine hydrochloride in combination, relating to the Company’s AQS1303 program to treat pregnant women experiencing nausea and vomiting. This is the conversion of a provisional application which was filed on August 17, 2015, and is based on positive results from both in-vivo and in-vitro studies. Aequus owns the world-wide rights to the formulations described in the patent application.
The doxylamine/pyridoxine combination is currently marketed as Diclegis® (US) / Diclectin® (Canada) for the treatment of nausea and vomiting of pregnancy (NVP), as an oral tablet dosed up to four times per day. According to US IMS data, Diclegis sales have been growing steadily since the product’s 2013 US launch, reaching approximately $120 million USD in 2015. It is estimated that 70% of women experience NVP, and in some severe cases it may persist throughout their entire pregnancy. NVP can have a significant impact on expectant mothers’ quality of life. The initial approach in managing NVP is to make dietary changes including the avoidance of trigger odors and foods. If that approach does not resolve symptoms on its own, guidance recommends the addition of pharmacotherapy. Diclegis®/Diclectin® is the only FDA- and Health Canada- approved medication recommended for the treatment of NVP.
The AQS1303 transdermal doxylamine/pyridoxine combination patch is being developed as a once-daily and up to a once-weekly form to provide women with a more convenient and easy to administer option. Aequus has engaged with over 400 new and expectant mothers and received resounding feedback regarding the level of discomfort associated with taking oral medication to manage their nausea and vomiting symptoms. This includes experiencing gag reflexes and vomiting immediately after taking a pill, leaving patients uncertain as to whether the medication has been absorbed and if taking another dose is required. A transdermal patch would provide patients with steady delivery of the medication without the requirement to ingest an oral dose.
“In my mind, this is one of the most intuitive uses for a transdermal patch,” said Anne Stevens, COO and Director of Aequus. “We are looking forward to providing women with an easy to use and convenient alternative to manage their nausea and vomiting symptoms during pregnancy.”
“This is another step forward in cultivating what is becoming a robust intellectual property portfolio,” said Doug Janzen, Chairman and CEO of Aequus. “As we advance each of our internal programs, our goal is to ensure we position ourselves in the best way possible to establish meaningful partnerships that will maximize the return to shareholders.”
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. For further information, please visit www.aequuspharma.ca.
FORWARD-LOOKING STATEMENT DISCLAIMER
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 AQS1303 and transdermal delivery, 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, and the expected benefits of AQS1303 and transdermal delivery. 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.
Aequus Investor Relations