- Aequus and Corium have expanded their relationship to include Aequus’ long-acting, transdermal patch for nausea and vomiting in pregnancy, AQS1303;
- Corium will utilize Corplex™, its industry leading, proprietary transdermal technology, to further advance AQS1303 for clinical testing;
- Corium will perform certain formulation work at no cost to Aequus in exchange for exclusive manufacturing rights for both the clinical program and the final commercial supply of AQS1303;
- Corium is a leading transdermal product developer and manufacturer, securing a highly capable and scalable manufacturing partner for AQS1303;
- Aequus and Corium will use the recent FDA guidance for AQS1303 to position the program for success;
- Aequus estimates peak sales potential for this program in the US to be approximately US$200M per annum.
Vancouver, British Columbia, June 21, 2018. 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 an expansion of its relationship with Corium International, Inc. (“Corium”) to include the Company’s long-acting transdermal patch, AQS1303, for the treatment of nausea and vomiting in pregnancy. Under the terms of the agreement, Corium will use its Corplex™ technology to improve the clinical performance of AQS1303 and will be the exclusive clinical and commercial manufacturer for the product. Aequus previously received positive FDA feedback for an accelerated regulatory pathway for AQS1303 compared to what a New Chemical Entity would require.
“The momentum of our anti-nausea program continues to build with this collaboration. We had multiple parties express interest in the commercial manufacturing rights as we continue to advance this program. We are delighted to have engaged with Corium, who will be performing the formulation activities required for the next stage of development on this program at its own cost and in return will be the exclusive clinical and commercial manufacturer for this product,” said Doug Janzen, CEO and Chairman of Aequus. “We have been working with the team at Corium for a number of years and are very pleased to be expanding our relationship to include this very exciting program.”
“We look forward to advancing this product opportunity through the application of our Corplex technology platform,” added Parminder “Bobby” Singh, Ph.D., Corium’s Chief Technology Officer and Vice President, Research and Development. “Nausea and vomiting associated with pregnancy are clear unmet needs where a transdermal route of administration has the potential to provide significant relief to affected women.”
The two parties previously signed a Multi-Product Collaboration Agreement, where Corium advanced Aequus’ extended release transdermal aripiprazole antipsychotic program, AQS1301. Corium has also performed certain scale up activities for the current formulation of the extended release anti-nausea patch.
Aequus recently announced its planned clinical strategy, with positive feedback from the FDA indicating 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 AQS1303 towards commercialization in major markets.
Aequus’ extended release 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 has grown its pipeline to include several commercial products in ophthalmology and transplant, and a development stage pipeline in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. As a complement to its focus in neurology, 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.
FORWARD-LOOKING STATEMENT DISCLAIMER
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.
Corplex™ is a trademark of Corium International, Inc.
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