VANCOUVER, BRITISH COLUMBIA--(Feb. 16, 2016) - Aequus Pharmaceuticals Inc. (TSX VENTURE: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:
- Improved patient adherence
- Delivery of lower peak plasma concentrations and lower input rate over an extended time period, resulting in smooth and consistent blood levels of topiramate or oxcarbazepine during the day
- Avoidance of blood level fluctuations that can be associated with side effects or breakthrough seizures
"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.
This release contains 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 in this release include but are
not limited to statements relating to: the implementation of our
business model and strategic plans. Aequus' anticipated regulatory
submissions and commercial activities in Canada in respect of Trokendi
XR® and Oxtellar XR®, the expected benefits of once-daily extended release forms of anti-epileptic drugs, the expected impact of Trokendi XR® and Oxtellar XR® commercialization
on Aequus, Aequus' existing commercial pipeline and Aequus' development
and strategic plan generally, the expectation that Aequus' transdermal
clobazam patch will enter clinical trials this year, estimated peak
sales for Trokendi XR® and Oxtellar XR®.
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
In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to general business and economic conditions, the suitability of Trokendi XR® and Oxtellar XR® to obtain regulatory approvals and commence commercial activities in Canada, the ability of Aequus to integrate Trokendi XR® and Oxtellar XR® into its existing pipeline and sales infrastructure, the development of Aequus' transdermal clobazam patch proceeding as expected, Aequus' assumptions regarding the peak sales of Trokendi XR® and Oxtellar XR® being accurate, the demand for Aequus and the expenses associated with Aequus' business continuing as expected by Aequus. 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 Short-Form Prospectus dated June 30, 2015, 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.
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