VANCOUVER, BC. November 16th , 2017 – 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 the European Patent Office has issued an intention to grant a European patent for AQS1301, Aequus’ once-weekly transdermal patch containing aripiprazole. AQS1301 is in development for the treatment of certain psychiatric disorders and is intended to provide patients with a long-acting dosing alternative that is a comfortable, convenient and easy-to-use in an effort to promote medication adherence.
This is the eighth regional patent issued or granted for AQS1301, following US, Russia, Mexico, Japan, China, Canada and Australia.
“With this patent, Aequus has now achieved intellectual property that spans across all major pharmaceutical markets for its once-weekly transdermal aripiprazole program,” said Anne Stevens, COO and Director of Aequus Pharmaceuticals. “This patent grant coincides nicely with our accelerated business development efforts, as we look to further develop this program in collaboration with regional partners.”
This patent covers 37 nations across Europe and provides intellectual property protection in the second largest antipsychotic market globally, a market where peak sales of Abilify® (branded oral aripiprazole) reached approximately $750 million USD in 2013 before patent expiry, according to IMS data. Although Abilify® is a market leader, Aequus believes it has limitations due to its daily dosing regimen which is associated with a high rate of non-adherence and associated likelihood of relapse due to non-adherence. Aequus’ proposed transdermal, once-weekly aripiprazole patch is designed to consistently deliver aripiprazole over a seven-day period at levels comparable to currently marketed once-daily formulations.
Aequus owns worldwide rights to the formulation described in the patent.
Aripiprazole is an atypical anti-psychotic sold as a once daily, oral tablet under the brand name Abilify®. Originally approved and marketed in 2002 for schizophrenia, Abilify® is currently sold in over 65 countries and regions. Since its initial approval, aripiprazole has seen a label expansion in the United States to include acute treatment of manic and mixed episodes associated with bipolar I, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, and treatment of Tourette’s disorder.
Aequus successfully completed an initial Proof of Concept clinical study for AQS1301 in December 2015, demonstrating that sustained, seven-day delivery of therapeutic doses may be possible with the current formulation. A follow-on Proof of Concept clinical study in healthy volunteers was completed in February 2017, demonstrating that steady state plasma concentrations were achieved by week three with relative concentrations of aripiprazole and its active metabolite, dehydroaripiprazole, comparable to oral dosing of Abilify®.
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. With a focus in neurology and other specialty areas, 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 contains 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 AQS1301 and transdermal delivery, the ability of the Company to add significant shareholder value in the near term, the Company’s intention to commercialize its internal programs in Canada, ability to form strategic partnerships in other markets, and the advancement of its technologies, products and product candidates. 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 the market for Aequus’ common shares, preferred shares, debt securities, subscription receipts, units and warrants; obtaining positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully out-license 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 under the heading “Risk Factors” in the Company’s Annual Information Form dated May 3, 2017, 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.
Abilify® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.