VANCOUVER, BC. August 24, 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 it has received positive feedback from the US Food and Drug Administration (FDA) to pursue the abbreviated 505(b)(2) clinical pathway for the company’s once-weekly transdermal aripiprazole patch, AQS1301, in development for the treatment of certain psychotic disorders.
Upon review of the Company’s pre-Investigational New Drug Application (Pre-IND) submission, the FDA agreed that AQS1301 is a suitable candidate for the 505(b)(2) regulatory pathway for approval in the United States. The FDA advised that a relative bioavailability (BA) study in patients comparing steady state pharmacokinetic (PK) between AQS1301 and the oral form would be acceptable if bioequivalence is established. This would provide a bridge to the aripiprazole safety and efficacy data from the approved Abilify® label at the target therapeutic doses. The FDA outlined additional standard studies required of a transdermal reservoir patch to evaluate the local safety and to ensure that consistent and predictable dosing is maintained over the seven-day dosing period without leakage or damage while being worn. Aequus development and manufacturing partner, Corium International, Inc. (NASDAQ: CORI) has extensive experience in the area of developing and manufacturing commercial stage transdermal patches meeting FDA requirements.
We are encouraged by the feedback from the FDA on the acceptability of an abbreviated clinical path forward for AQS1301, said Anne Stevens, Chief Operating Officer and Director of Aequus. This provides validation for our organization to accelerate partnership discussions for this program as we look to collaboratively advance AQS1301 through clinical studies.
The outcome of the interaction with the FDA provides clarity on the requirements for Aequus and the development goals for AQS1301 in order to achieve FDA approval under 505(b)(2), said Gary Barnette, Senior Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services, LLC. We are pleased to be partnered with Aequus and to assist in achieving this important milestone.
Aequus owns the global rights to this program, and will look to find a strategic partner to advance AQS1301 through the planned clinical studies and towards commercialization in major markets.
A Section 505(b)(2) NDA is a new drug application in which the FDA and applicant may rely on certain investigations of safety and effectiveness that were previously conducted by someone other than the applicant, and is often applicable to an active drug substance that has previously been approved in a different dosage form.
Aripiprazole is an atypical anti-psychotic sold 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. In 2015, Abilify® saw its first generic competition in the USA as its patent exclusivity expired. For 2015, aripiprazole US sales totaled $6.3 billion, with branded Abilify® representing 70% of sales revenues. Aripiprazole remains one of the most commonly prescribed anti-psychotics globally, with the compound currently available in oral tablets, oral solution, and intramuscular injection.
AQS1301 is designed to consistently deliver aripiprazole over a seven-day period at levels comparable to currently marketed once-daily formulations. By delivering aripiprazole over seven days in a comfortable, convenient and easy-to-use weekly patch, AQS1301 is intended to promote enhanced patient compliance.
Aequus has advanced the once-weekly, transdermal aripiprazole patch with its development and manufacturing partner, Corium. 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®.
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
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com
The Company issued Camargo Pharmaceutical Services, LLC 47,004 common shares on August 21, 2017 in connection with a service agreement to provide regulatory consulting services for the Company’s product development programs in the United States.
FORWARD-LOOKING STATEMENT DISCLAIMER
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 our clinical trial and regulatory timing and plans, the achievement of clinical and commercial milestones, and the advancement of our technologies and our 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.