Aequus Licenses Canadian Commercialization Rights to Trokendi XR ® and Oxtellar XR ® from Supernus

Feb 16, 2016

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.

About Trokendi XR and Oxtellar XR

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.

About Aequus Pharmaceuticals

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.

About Supernus Pharmaceuticals

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.

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 implementation of our business model and strategic plans; revenue growth trends into the future; expected timing for product launches; the Company’s expected revenues; the regulatory approval of its products; the Company’s ability to attract international partners; and ongoing discussions with and the Company’s ability to secure potential partners to further grow our product portfolio. 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 regulatory approvals; general business and economic conditions; the Company’s ability to successfully out license or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with 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; the impact of the coronavirus (COVID-19) on the Company’s operations; 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 30, 2021, 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.
Aequus Contact Information
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