Aequus Granted European Patent for Once-Weekly Transdermal Aripiprazole
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®.