Key Highlights
- FDA has confirmed that an abbreviated 505(b)(2) regulatory pathway would be appropriate for the submission of AQS1303, Aequus’ long-acting anti-nausea patch for nausea and vomiting associated with pregnancy, for approval in the United States;
- FDA has indicated that a bioequivalence study to bridge oral Diclegis® safety and efficacy data with AQS1303 is likely acceptable, reducing the clinical requirements for the program compared to a typical new chemical entity drug submission;
- FDA has agreed with Aequus’ proposed clinical plan for AQS1303 which is expected to include only a single clinical efficacy study;
- This long-acting anti-nausea transdermal patch is intended to solve for the heavy pill burden of the current oral version which is currently dosed up to 4 times per day in women with nausea and vomiting of pregnancy;
- The oral version of this medication sold approximately $186M USD in the United States in 2017, according to IQVIA data.
VANCOUVER, British Columbia, May 03, 2018 (GLOBE NEWSWIRE) -- 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 Company has received positive feedback from the US Food and Drug Administration (“FDA”) on its pre-Investigational New Drug (“pre-IND”) submission for the Company’s long-acting anti-nausea transdermal patch, AQS1303. Through the pre-IND feedback, the Company has received clear regulatory guidance for AQS1303. The FDA confirmed that the planned Section 505(b)(2) abbreviated regulatory pathway, which allows for the Company to reference safety and efficacy data of the original oral tablet Diclegis®, is appropriate for submission in a New Drug Application (“NDA”) for the program in the United States.
“We are very encouraged with the responses from the FDA on our anti-nausea program,” said Doug Janzen, Chairman and CEO of Aequus. “The pre-IND feedback met our expectations, confirming our planned clinical program and providing a clear regulatory path forward. The feedback signals positive support for this program and further confirms our overall strategy of improving patient outcomes through alternative delivery methods. We look forward to using this guidance in conjunction with our current development and clinical progress to optimize AQS1303 for success.”
“Camargo’s goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners,” said Ken Phelps, President and Co-Founder of Camargo Pharmaceutical Services. “We look forward to continuing work with Aequus to advance their anti-nausea patch for pregnancy nausea and vomiting, to benefit patients worldwide.”
In support of the Company’s planned clinical strategy, the FDA indicated that a pharmacokinetic bridging strategy, to allow bridging to the safety and clinical pharmacology information from Diclegis®, and a single clinical efficacy study, would likely be acceptable for an NDA submission. The FDA also outlined additional standard studies required of a transdermal patch to evaluate the local safety and to ensure that consistent and predictable dosing is achieved over the dosing period.
Aequus owns global rights to this program and is excited about advancing both clinical and strategic discussions as the Company advances AQS1303 towards commercialization in major markets.
ABOUT AQS1303
Aequus’ long-acting transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®) currently used to treat nausea and vomiting of pregnancy. AQS1303 is designed to provide patients with a convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. According to IQVIA data, Diclegis® sales in the United States were approximately $186M USD for 2017.
Aequus has advanced AQS1303 through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
Based on FDA feedback, this product is expected to follow a Section 505(b)(2) New Drug Application, an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.
ABOUT AEQUUS PHARMACEUTICALS INC.
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.
ABOUT CAMARGO PHARMACEUTICAL SERVICES, LLC.
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
Forward-Looking Statements:
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 include but are not limited to statements relating to: the further advancement of AQS1303, the regulatory requirements for AQS1303, and the Company’s ability to form strategic partnerships for its internal programs. 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: obtaining positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully outlicense 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 herein and 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.
Diclegis® and Diclectin® are registered trademarks of Duchesnay Inc.
Contact Information:
Aequus Investor Relations
Email: investors@aequuspharma.ca
Phone: 604-336-7906