SOURCE: Aequus Pharmaceuticals

Aequus Pharmaceuticals

April 28, 2016 09:23 ET

Aequus Pharmaceuticals Initiates Promotional Efforts for VISTITAN™ in Canada

VANCOUVER, BC--(Marketwired - April 28, 2016) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company") announced today that it has initiated commercial activities for PRVistitan™ (bimatoprost 0.03%, ophthalmic solution) in the Canadian market, which is a prostaglandin approved as a treatment for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

The prostaglandins remain a primary treatment option for lowering IOP in glaucoma. Bimatoprost is currently only available in a 0.01% formulation in Canada and represents approximately 30% market share by dollar volume of IOP-lowering medications in Canada as of 2014, accounting for $42.1M in sales revenues. In a dose-response study, bimatoprost 0.03% demonstrated significantly better efficacy versus bimatoprost 0.01% with a similar safety profile.

"We are extremely pleased to be working with our partner to bring bimatoprost 0.03% back to the Canadian market," said Ian Ball, CCO of Aequus. "Canadian patients will be able to benefit from this product's demonstrated efficacy and lower price compared to the 0.01% formulation."

"The launch of our second commercial product is a proud achievement for Aequus. It has been exciting to see our sales team steadily growing revenues of tacrolimus since the start of the year and we look forward to building the Vistitan brand and revenues over the coming months and years," said Doug Janzen, CEO of Aequus.

As previously announced, Aequus and its partner will split revenues of this product based on an undisclosed tiered royalty structure.

About PRVISTITAN™

Bimatoprost is a synthetic prostamide analogue and is structurally related to prostaglandin F2α. Its mechanism of action resembles that of prostaglandin F2α, a naturally occurring substance. Vistitan, which was approved by Health Canada in 2014, is currently the only marketed version of 0.03% bimatoprost ophthalmic solution indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost 0.03% has been studied in two randomized, multicenter, double-blinded, parallel-group clinical studies, of 12 months duration, conducted on 1198 patients with glaucoma or ocular hypertension, versus timolol twice-daily as an active control. Over the 12 month study duration bimatoprost predictability lowered IOP in over 90% of patients to 22mgHg or less, with approximately 50% of patients having IOPs of 17mmHg or less. Additionally, in a meta-analysis published by CADTH in 2015, bimatoprost 0.03% was demonstrated to be superior or equivalent to other prostaglandins in reducing IOP.

In a Phase 2 dose-response study conducted by Allergan, which included 60 patients with twice-daily dosing for 5±2 days showed significant reductions from baseline IOP with bimatoprost 0.01% and 0.03% formulations as well as with timolol 0.5%, compared to vehicle. Among the bimatoprost concentrations evaluated, 0.03% had the best ratio of safety to efficacy.

 The effects of 0.003%, 0.01% and 0.03% bimatoprost (non-preservative formulations) and of twice-daily versus once-daily (evening) dosing were compared to timolol 0.5% and vehicle in 100 patients treated for one month. Although 0.01% and 0.03% had similar safety profiles, 0.03% had significantly better efficacy. There was no significant difference in efficacy between twice-daily and once-daily dosing.

Please refer to the product monograph for more details.

About Aequus Pharmaceuticals

Aequus Pharmaceuticals Inc. (TSX VENTURE: 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. Aequus also 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

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements:

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 timing and amount of revenues that the Company may receive from its currently announced commercial products; the ability of the Company to reach its revenue goals; the implementation of our business model and strategic plans; Aequus' anticipated regulatory submissions and commercial activities in Canada in respect of Vistitan, the expected benefits of once-daily extended release forms of anti-epileptic drugs; the expected impact of Vistitan commercialization on Aequus; and the estimated peak sales for Vistitan. 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 general business and economic conditions, the suitability of Vistitan to commence commercial activities in Canada, the ability of Aequus to integrate Vistitan into its existing pipeline and sales infrastructure, Aequus' assumptions regarding the sales of Vistitan being accurate, and 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.

TM: Trademark owned or used under license by Sandoz Canada Inc.

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