Vancouver, BC. February 16, 2016 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), announced today that it has entered into a licensing agreement for the Canadian commercial rights to Trokendi XR ® and Oxtellar XR ® with Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a U.S.-based specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system disorders. Both products are branded, once-daily, extended-release products for the treatment of epilepsy, and have been successfully marketed by Supernus in the U.S. since 2013.
Under the terms of the license agreement, Aequus will be responsible for the regulatory submission and commercial activities for both products in Canada. Supernus is eligible to receive milestone payments and royalties from product sales in Canada. Aequus anticipates submitting an application for regulatory approval with Health Canada in the second half of 2016 for both products.
Both topiramate and oxcarbazepine, the active ingredients in Trokendi XR and Oxtellar XR, respectively, are currently only available in Canada as immediate release formulations, requiring twice daily dosing. The expected benefits of once-daily extended release forms of anti-epileptic drugs such as Trokendi XR and Oxtellar XR include:
“We are incredibly proud to be introducing these products to the Canadian market, where there are limited once-daily options available to patients with epilepsy in particular,” said Anne Stevens, COO and Director of Aequus. “These products are a perfect complement to our internal development pipeline, particularly AQS1302, a long acting transdermal clobazam patch which is expected to enter clinical trials later this year. Together these products provide long-acting treatment alternatives for patients with epilepsy, where nearly two-thirds of patients are treated with multiple medications to control their seizures,” added Ms. Stevens. “We will continue to focus on building our pipeline around high quality, differentiated products to improve patient adherence.”
“We believe these two branded products are company builders for Aequus. These two assets strengthen our commercial pipeline and fit with the strategic plan that we put into place when we acquired TeOra Health last summer. Our initial focus has been on specialty generic products, with an expectation to evolve our sales infrastructure to build our presence in neurology around high-value branded therapies which would provide us with a platform on which to launch our own internal transdermal neurology programs in the future” said Doug Janzen, Chairman and CEO of Aequus. “This agreement demonstrates our ability to execute on our strategy of in-licensing targeted products, both branded and specialty generic, for sale in the Canadian market from sophisticated pharmaceutical partners such as Supernus. Revenues from these two products alone will ensure our profitability in the coming years.”
“We are excited about Aequus’ plan to market Trokendi XR and Oxtellar XR in Canada. We are very pleased to partner with a specialty pharmaceutical company whose strategic priority is to build a strong neurology portfolio in Canada, and where Trokendi XR and Oxtellar XR represent the cornerstone of such portfolio.” said Jack Khattar, President & CEO of Supernus.
Trokendi XR is a novel, oral, extended-release, once-daily formulation of topiramate currently approved in the U.S. for the treatment of epilepsy. Topiramate, the active ingredient in Trokendi XR is also approved for the prevention of migraine headaches in the U.S. and Canada. In Q4 2015, Supernus filed a supplemental NDA to add the migraine indication to the Trokendi XR label. Trokendi XR was approved by the FDA in August 2013 based on a comprehensive NDA consisting of several pharmacokinetic (PK) studies demonstrating bioequivalence between Trokendi XR and immediate release topiramate. It is available in the U.S. in 25mg, 50mg, 100mg and 200mg extended-release capsules. For full prescribing and safety information, click here.
Oxtellar XR is a novel, oral, extended-release, once-daily formulation of oxcarbazepine currently approved in the US for the treatment of epilepsy. The product is available in 150mg, 300mg, and 600mg extended-release tablets and was approved by the FDA in October 2012, based on several PK studies and a randomized, double-blind, placebo-controlled phase III trial in adults with partial seizures. For full prescribing and safety information, click here.
For the full year of 2014, Trokendi XR and Oxtellar XR in aggregate reached net sales of US$89.6 million in the U.S. market, and for the first three quarters of 2015 they reached US$100.9 million.
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a Vancouver-based, specialty pharmaceutical company primarily 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 and to establish strategic partnerships to accelerate product development and maximize the reach of its product candidates worldwide. Through the recent acquisition of TeOra Health, Aequus now has a Canadian commercial platform to build on for the launch of 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.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company has two marketed products for epilepsy, Oxtellar XR ® (extended-release oxcarbazepine) and Trokendi XR ® (extended-release topiramate). The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of impulsive aggression in patients with ADHD in conjunction with standard ADHD treatment and SPN-812 for ADHD. For further information, please visit www.supernus.com.