Vancouver, BC. AUGUST 5, 2016 – 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.”
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.