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.