Aequus and Corium Join Forces to Advance Anti-Nausea Transdermal Patch
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 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (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.