Aequus Pharmaceuticals Inc. (TSX-V:AQS.V) (OTCQB:AQSZF) - Breaking News
May 3, 2018

Aequus Receives Positive FDA Regulatory Guidance for Anti-Nausea Patch

Key Highlights
• FDA has confirmed that an abbreviated 505(b)(2) regulatory pathway would be appropriate for the submission of AQS1303, Aequus’ long-acting anti-nausea patch for nausea and vomiting associated with pregnancy, for approval in the United States;
• FDA has indicated that a bioequivalence study to bridge oral Diclegis® safety and efficacy data with AQS1303 is likely acceptable, reducing the clinical requirements for the program compared to a typical new chemical entity drug submission;
• FDA has agreed with Aequus’ proposed clinical plan for AQS1303 which is expected to include only a single clinical efficacy study;
• This long-acting anti-nausea transdermal patch is intended to solve for the heavy pill burden of the current oral version which is currently dosed up to 4 times per day in women with nausea and vomiting of pregnancy;
• The oral version of this medication sold over $160M USD in the United States in 2016, according to IQVIA data.

Vancouver, British Columbia --May 3, 2018 -- Aequus Pharmaceuticals Inc. (TSX-V:AQS.V) (OTCQB:AQSZF)  (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the Company has received positive feedback from the US Food and Drug Administration (“FDA”) on its pre-Investigational New Drug (“pre-IND”) submission for the Company’s long-acting anti-nausea transdermal patch, AQS1303. Through the pre-IND feedback, the Company has received clear regulatory guidance for AQS1303. The FDA confirmed that the planned Section 505(b)(2) abbreviated regulatory pathway, which allows for the Company to reference safety and efficacy data of the original oral tablet Diclegis®, is appropriate for submission in a New Drug Application (“NDA”) for the program in the United States.

“We are very encouraged with the responses from the FDA on our anti-nausea program,” said Doug Janzen, Chairman and CEO of Aequus. “The pre-IND feedback met our expectations, confirming our planned clinical program and providing a clear regulatory path forward. The feedback signals positive support for this program and further confirms our overall strategy of improving patient outcomes through alternative delivery methods. We look forward to using this guidance in conjunction with our current development and clinical progress to optimize AQS1303 for success.”

“Camargo’s goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners,” said Ken Phelps, President and Co-Founder of Camargo Pharmaceutical Services. “We look forward to continuing work with Aequus to advance their anti-nausea patch for pregnancy nausea and vomiting, to benefit patients worldwide.”

In support of the Company’s planned clinical strategy, the FDA indicated 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 both clinical and strategic discussions as the Company advances AQS1303 towards commercialization in major markets.

ABOUT AQS1303
Aequus’ long-acting 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 over $160M USD for 2016.

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.
ABOUT AEQUUS PHARMACEUTICALS INC.

Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a growing specialty pharmaceutical company 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. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional 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 CAMARGO PHARMACEUTICAL SERVICES, LLC.
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com

Forward-Looking Statements:

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 further advancement of AQS1303, the regulatory requirements for AQS1303, and the Company’s ability to form strategic partnerships for its internal programs. 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 positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully outlicense or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with its manufacturer and other 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; 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 29, 2016, 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.

Diclegis® and Diclectin® are registered trademarks of Duchesnay Inc.
Contact Information:
Aequus Investor Relations
Email: investors@aequuspharma.ca
Phone: 604-336-7906

SOURCE Aequus Pharmaceuticals Inc.

Aequus Provides Fourth Quarter and Fiscal 2017 Financial Highlights, Third Consecutive Quarter of Revenue Growth

Vancouver, British Columbia --April 27, 2018 -- Aequus Pharmaceuticals Inc. (TSX-V:AQS.V) (OTCQB:AQSZF)  (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the full year ended December 31, 2017. Unless otherwise noted, all figures are in Canadian currency.

“With a now established track record of launching products, a sales and marketing team providing full Canadian coverage, and a history of deals with major players, Aequus now finds itself in a strong position as a preferred partner providing a unique and flexible deal structure in the Canadian marketplace,” said Doug Janzen, Chairman and CEO of Aequus. “We then leverage those revenues and relationships with Canadian clinicians to fund and inform our reformulated drug delivery products, which are global products that have significant revenue potential.”

Key 2017 Financial Highlights

> Strongest revenue quarter to date, with fourth quarter 2017 total revenue of $368,682, an increase of 121% over the same quarter in 2016
> Achieved profitability in commercial division in fourth quarter of 2017
> Fourth quarter 2017 net loss of $640,770, a decrease of 45% over the same quarter in 2016
> Full year 2017 total revenue of $1.1 million, an increase of 62% over 2016
> Full year 2017 net loss of $3.8 million, a decrease of 19% over 2016

Key 2017 Operational Highlights
Acquired rights for a transdermal patch containing cannabinoids for the use in certain neurological disorders, and established a series of collaborative partnerships including Scientus, EHAVE and the CDRD to advance various drug delivery programs for medical cannabis to satisfy prescriber needs;

Closed a $5.2M financing underwritten by Canaccord Genuity Corp.;

Successfully completed initial Proof of Concept clinical trial for Aequus’ long-acting transdermal anti-nausea patch, AQS1303, with positive results;

Received positive feedback from FDA regarding the suitability of its once-weekly transdermal patch for aripiprazole to follow an abbreviated regulatory pathway for approval in the US;

Entered into a commercial collaboration with Santen Inc, the Canadian Branch (“Santen”), a subsidiary of Santen Pharmaceutical Co., Ltd. to become its exclusive promotional and marketing partner for an ophthalmology product in Canada;
Subsequent to December 31, 2017

In January 2018, Aequus announced a collaboration with CannaRoyalty Corp. (“CannaRoyalty”) to advance a suite of cannabis-based therapies targeting neurological disorders into clinical trials in Canada, in collaboration with Canadian doctors and key opinion leaders;

In April 2018, Aequus’ partner, Santen, received a Notice of Non-Compliance by Health Canada for the product contemplated under the previously announced commercialization agreement. The Company expects the current agreement to be wound up following the recent decision by Health Canada. Aequus looks forward to continued discussions with Santen around potential future products;

In April 2018, Aequus entered into an exclusive commercial and distribution agreement with Mynosys for the promotion of Zepto Precision Pulse Capsulotomy System in Canada.

Commercial Update

Revenue during the year ended December 31, 2017 was $1,139,424, an increase of 62% in annual revenues compared to 2016. Q4 of 2017 was the Company’s strongest quarter to date, with total revenues of $368,682, an increase of 121% over the same quarter in 2016.

VistitanTM revenues are expected to continue to increase in the current fiscal year as it continues to gain market share held by similar medications within the class. Tacrolimus IR sales may be more volatile in 2018 due to competitive dynamics. This volatility is expected to be offset by new revenues from Zepto®, which is expected to be launched in Q2 2018.

“We are very pleased with the growth of our commercial franchise achieved in 2017,” says Ian Ball, Chief Commercial Officer of Aequus. “We launched Vistitan less than two years ago and have exceeded a million dollars in total annual revenues for the first time. The recently announced Zepto transaction leverages our existing sales infrastructure and will begin to generate revenues in Q2, we also have additional commercial products in various stages of negotiation. We expect strong revenue growth in 2018 and note that the commercial activities have been cash-flow positive for the past few months based on our expected revenues. It is significant to see the commercial arm contributing cash flow to off-set development and administration expenses.”

Aequus looks to leverage its core capabilities, commercial infrastructure and existing product portfolio that it has been growing through promotional partnership agreements, asset acquisitions, in-licenses and in the future with the Company’s own internal development programs as they mature and enter the market. The Company’s near-term commercial growth strategy includes the progressive build-out of the Company’s commercial platform, including leveraging its specialty sales force and relationships with physicians in Canada to enable Aequus to continue to in-license and sell high value branded products in Canada.

Alongside the Company’s expected growth in ophthalmology, the Company plans to expand its neurology franchise by advancing clinical studies for its medical cannabis program in the coming months, following the completion of several recently announced collaborative partnerships in this field. Namely, Aequus formed a collaboration with Scientus Pharma, Inc. (“Scientus”) to be the development and commercial supplier of specific cannabinoid extracts, with an option for Scientus to co-fund the development of a cannabinoid containing transdermal formulation that would be designed and optimized to address certain neurological disorders. Additionally, the Company entered into a collaboration with Ehave, Inc. (“Ehave”) to access Ehave’s bioinformatics platform to enhance and streamline data management processes for Aequus-sponsored clinical trials studying specific cannabinoid-rich formulations for treating a number of neurological disorders. On June 1, 2017, Aequus entered into a broad research collaboration with the Centre for Drug Research and Development (“CDRD”) to establish pre-clinical safety and efficacy of select cannabinoid-based therapeutics targeting certain neurological movement disorders. And most recently, in January 2018, Aequus announced a collaboration with CannaRoyalty Corp. (“CannaRoyalty”) to advance a suite of cannabis-based therapies targeting neurological disorders into clinical trials in Canada, in collaboration with Canadian doctors and key opinion leaders.

The Company also expects to pursue a small clinical study for Topiramate Extended-Release (“Topiramate XR”) to support a New Drug Submission (“NDS”) in 2018, intended for the treatment of epilepsy.

Progress of Product Pipeline

The Company continued to invest in its development pipeline in 2017. Aequus completed an initial Proof of Concept clinical trial to evaluate the bioavailability and safety of Aequus' long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®). AQS1303 could provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. This Proof of Concept study was designed as a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, in nine healthy 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.

The Company also advanced AQS1301, a once-weekly transdermal formulation of aripiprazole through a multi-dose Proof of Concept clinical study which was completed in February 2017, demonstrating that steady state was achieved in week three of dosing in healthy volunteers, with comparable plasma concentrations to the orally delivered form of aripiprazole, Abilify®. Aequus also expanded the patent portfolio for this program with a patent issued/allowed in seven major countries or regions to date, namely the United States, Russia, Mexico, Japan, Australia, Canada and China with several other major markets pending.

Aequus received positive feedback from the US Food and Drug Administration (“FDA”) in a pre-Investigational Drug Application (“pre-IND”) meeting for the Company’s lead development program, AQS1301, a once-weekly transdermal formulation of aripiprazole. Upon review of the Company’s pre-IND submission, the FDA agreed that AQS1301 is a suitable candidate for the 505(b)2 abbreviated regulatory pathway for approval in the United States.

Aequus has been engaging with third parties around partnering discussions for each of its internal programs, with a goal of ensuring that the maximum benefit is realized by shareholders.

Operating Expenses

Research and development expenses in the fourth quarter of 2017 were $19,590, as compared to $295,115 in the same quarter last year, and for the full year 2017, $1,414,706, as compared to $1,127,780 for 2016. The increase was primarily attributable to subcontractor costs, specifically regulatory consulting for AQS1301 and AQS1303 Pre-IND related work, the development of AQS1303 clinical trial materials and the execution of the Proof of Concept study for AQS1303. In Q4 2017, the Company prepared for the Pre-IND meeting for AQS1303 and was active in establishing collaborative partnerships in anticipation of advancing its medical cannabis programs.

Sales, marketing and general administration expenses in the fourth quarter of 2017 were $992,882, as compared to $1,059,635 in the same quarter last year, and for the full year 2017, $3,727,176 as compared to $4,437,436 in 2016. During Fiscal 2016 the Company incurred relatively high promotional spending associated with launch activities for Tacrolimus IR and Vistitan™ in Canada whereas there were no similar start-up costs in Fiscal 2017. Additionally, in 2017 there was a decrease in management fees, regulatory consultant spending and share-based payments expense.

Aequus reported a loss before other income of $640,770, a decrease of 45% over the same quarter in 2016, and for the full year 2017 a net loss of $3,882,427, a decrease of 19% over 2016. This improvement in loss before other income for both periods is primarily due to growing revenues from its sales and marketing activities in 2017 for its two commercially promoted products, Tacrolimus IR and Vistitan™.

About Tacrolimus IR

Tacrolimus immediate release is an immunosuppressant used for the treatment and prevention of acute rejection following organ transplantation. Tacrolimus is part of a patient’s immunosuppressive therapy prescribed chronically in their lifelong management to prevent graft rejection. In 2015, the immunosuppressive market in Canada reached $241M in sales, with tacrolimus products accounting for $100M. With the assistance of Aequus’ promotional efforts and commercial team, the tacrolimus IR generic grew 90% year-over-year by unit volume in 2016 when compared to 2015 based on ex-factory data.

About Vistitan™

Vistitan™ (bimatoprost 0.03%, ophthalmic solution), is a branded generic prostaglandin approved by Health Canada for the reduction of elevated IOP in patients with open angle glaucoma or ocular hypertension. The Canadian glaucoma market in 2015 was estimated to be over $182 million, of which prostaglandins remain one of the primary treatment options for lowering IOP in glaucoma. VistitanTM, which was approved by Health Canada in 2014, is currently the only marketed version of 0.03% bimatoprost ophthalmic solution in Canada.

About Zepto Precision Pulse Capsulotomy System

The Zepto capsulotomy system provides consistent, high quality anterior lens capsulotomies during cataract surgery in a convenient, cost-effective, disposable format. One of the key features is a collapsible super-elastic nitinol capsulotomy ring element with micron scale elements to create the unique and strong Zepto capsulotomy edge. It also has a clear silicone suction cup to enable suction and generate Zepto’s proprietary capsulotomy action and to allow Zepto capsulotomies on the patient’s individual visual axis. The AMA has recently given a category III code in the US as they see the distinctive application and benefit of aligning on the patient’s own visual axis.

Zepto integrates seamlessly into the routine steps of cataract surgery with phacoemulsification. The surgeon does not need to alter his or her normal routine. Instead of capsulorrhexis forceps or a cystitome, the surgeon simply reaches for Zepto.

The Zepto Capsulotomy System consists of a disposable Zepto capsulotomy handpiece that is attached to a small control console. Zepto uses the precision pulse capsulotomy method, a proprietary combination of calibrated suction and a 4-millisecond multipulse energy algorithm to produce highly accurate capsulotomies. Zepto’s unique single use hand piece can be inserted through incisions as small as 2.2mm, to create a perfectly circular and precisely placed capsulotomy that can be centred on the visual axis. Zepto is ideal for surgery using premium lenses as well as difficult cases and creates a capsulotomy with an edge strength greater than conventional methods or femtosecond lasers. For more information, please visit https://www.zepto-cataract.com/.

ABOUT AEQUUS PHARMACEUTICALS INC.

Aequus Pharmaceuticals Inc. (TSX-V:AQS) (OTCQB:AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its pipeline to include several commercial products in ophthalmology and transplant, and a development stage pipeline in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. As a complement to its focus in neurology, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional 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.

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; the Company’s expected revenues; the timing of public listings; the advancement of the Company’s transdermal pyridoxine/doxylamine program into a Proof of Concept clinical study; the Company’s potential regional partnerships for its internal programs; the timing of public reimbursement decisions for VistitanTM; the timing of the Company’s follow-on, multi-dose bioavailability study for the its transdermal aripiprazole program; and the Company’s expectations regarding the tech transfer to its development partner with respect to the Company’s transdermal patch for clobazam. 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 positive results of clinical trials; 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 its manufacturer and other 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; 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 May 1, 2017, 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 and Camargo Complete Pre-Investigational New Drug Submission with FDA for Transdermal Anti-Nausea Program

Vancouver, British Columbia --April 17, 2018 -- Aequus Pharmaceuticals Inc. (TSX-V:AQS.V) (OTCQB:AQSZF)  (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has issued Camargo Pharmaceutical Services, LLC (“Camargo”) 120,111 common shares on April 11, 2018 in connection with the previously announced completion of a pre-Investigational New Drug (“pre-IND”) meeting submission for AQS1303, Aequus’ long-acting transdermal anti-nausea patch for the treatment of nausea and vomiting of pregnancy. The Company submitted the pre-IND meeting package to the US Food and Drug Administration (“FDA”) for review and anticipates FDA feedback by the end of April 2018, which will define the clinical strategy for regulatory approval in the USA for AQS1303.

The product is expected to follow a Section 505(b)(2) New Drug Application (NDA), 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. Aequus owns the global rights to this program and will look to find a strategic partner to advance it towards commercialization in major markets.

The shares issued are as per a previously announced service agreement with Camargo, to provide regulatory consulting services for the Company’s product development programs in the United States.

ABOUT AQS1303

Aequus’ long-acting 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.

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.

This product is expected to follow a Section 505(b)(2) New Drug Application (NDA), 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.

ABOUT AEQUUS PHARMACEUTICALS INC.

Aequus Pharmaceuticals Inc. (TSX-V:AQS) (OTCQB:AQSZF) is a growing specialty pharmaceutical company 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. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional 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 CAMARGO PHARMACEUTICAL SERVICES, LLC.

Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com

Forward-Looking Statements:

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: expected benefits of AQS1303 and transdermal delivery, the further advancement of AQS1303, the regulatory requirements for AQS1303, and the Company’s ability to form strategic partnerships for its internal programs. 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 positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully outlicense or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with its manufacturer and other 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; 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 29, 2016, 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.

Diclegis® and Diclectin® are registered trademarks of Duchesnay Inc.

Contact Information:

Aequus Investor Relations
Email: investors@aequuspharma.ca
Phone: 604-336-7906
 

Aequus Adds Zepto Capsulotomy System, A Revenue Generating Product, to Commercial Ophthalmology Portfolio

Vancouver, British Columbia --April 12, 2018 -- Aequus Pharmaceuticals Inc. (TSX-V:AQS.V) (OTCQB:AQSZF)  (“Aequus” or the “Company”), is pleased to announce it has entered into a commercial agreement with Mynosys Cellular Devices, an ophthalmology focused medical device company based in Fremont, California, (“Mynosys”) for the Canadian distribution, sales and marketing of the Zepto® Precision Pulse Capsulotomy System (“Zepto”) for cataract surgery. Zepto was approved for sale in Canada by the Therapeutic Products Directorate in February 2018, and through this agreement is expected to be launched in Canada by Aequus within the next quarter. Zepto will be marketed by Aequus’ current ophthalmology salesforce and is an attractive complement to its existing product offering.

“The addition of the Zepto device expands Aequus’ ophthalmology portfolio into the cataract surgical space and reaffirms our commitment to this therapeutic area,” said Anne Stevens, COO and Director of Aequus. “In meetings with Canadian ophthalmologists, clinicians expressed a strong interest for this product, particularly in the premium intraocular lens market and the more challenging cases, which we estimate to represent over 20% of cataract cases performed each year in Canada.”

Zepto has been used in thousands of cataract surgeries in Asia, Europe, and Central America since February 2017, and most recently in the US since August 2017.

John Hendrick, President and CEO of Mynosys, stated: “I am delighted to have Aequus as our partner to bring Zepto to the market in Canada. We have seen a significant demand for Zepto around the world and fully expect that Zepto will be embraced by the Canadian market as well”.

This agreement has an initial term of three years, with an automatic and continuous renewal of additional three year terms, provided Aequus meets minimum sales targets. Aequus will retain profits on the products sold in Canada.

About Zepto Precision Pulse Capsulotomy System

The Zepto capsulotomy system provides consistent, high quality anterior lens capsulotomies during cataract surgery in a convenient, cost-effective, disposable format. One of the key features is a collapsible super-elastic nitinol capsulotomy ring element with micron scale elements to create the unique and strong Zepto capsulotomy edge. It also has a clear silicone suction cup to enable suction and generate Zepto’s proprietary capsulotomy action and to allow Zepto capsulotomies on the patient’s individual visual axis. The AMA has recently given a category III code in the US as they see the distinctive application and benefit of aligning on the patient’s own visual axis.

Zepto integrates seamlessly into the routine steps of cataract surgery with phacoemulsification. The surgeon does not need to alter his or her normal routine. Instead of capsulorrhexis forceps or a cystitome, the surgeon simply reaches for Zepto.

The Zepto Capsulotomy System consists of a disposable Zepto capsulotomy handpiece that is attached to a small control console. Zepto uses the precision pulse capsulotomy method, a proprietary combination of calibrated suction and a 4-millisecond multipulse energy algorithm to produce highly accurate capsulotomies. Zepto’s unique single use hand piece can be inserted through incisions as small as 2.2mm, to create a perfectly circular and precisely placed capsulotomy that can be centered on the visual axis. Zepto is ideal for surgery using premium lenses as well as difficult cases and creates a capsulotomy with an edge strength greater than conventional methods or femtosecond lasers. For more information, please visit https://www.zepto-cataract.com/.

About Aequus Pharmaceuticals, Inc.

Aequus Pharmaceuticals, Inc. (TSX-V:AQS) (OTCQB:AQSZF) is a growing specialty pharmaceutical company 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. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional 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 Mynosys Cellular Devices

Mynosys Cellular Devices Inc. is a medical device company providing innovative solutions to help surgeons achieve perfection in cataract surgery. Our product Zepto®, is a unique micro-fabricated instrument that provides unmatched precision during surgery on a millisecond time scale to tackle routine and challenging cases with confidence and efficiency. Zepto technology is patented worldwide and is available in selected markets through local distributors.

Forward-Looking Statements:

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 in this release include but are not limited to statements relating to: identifying barriers to current use and potential product offerings in specific therapeutic areas, the implementation of our business model and strategic plans, Aequus’ sales and marketing efforts. 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: the success of Aequus’ sales and marketing efforts, general business and economic conditions, the assumption that the Company’s current good relationships with its manufacturer and other 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. In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors set out under the heading “Risk Factors” in the Company’s Annual Information Form dated April 29, 2016, 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.

Contact Information:
Aequus Investor Relations
Email: investors@aequuspharma.ca
Phone: 604-336-7906

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About Aequus Pharmaceuticals Inc.:

Aequus Pharmaceuticals Inc. (TSX-V: AQS) is a rapidly growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ management team has a proven track record of managing drug development from product validation through commercial launch, including clinical development and regulatory approval processes as well as launching and marketing products both directly and with commercial partners.

Aequus’ sales and marketing efforts are based in Canada, targeting highly specialized therapeutic areas including neurology, ophthalmology and transplant. Aequus is developing a pipeline of 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 and maximize the potential of its product candidates worldwide.

Commercial strategy. Aequus has a pipeline of commercial and near-commercial products that have been brought in through an acquisition or license to be marketed in Canada. We will continue to expand our commercial pipeline with high quality, differentiated products including patented products, branded generics, and reformulated novel-delivery products within focused therapeutic areas. Aequus continues to evaluate and develop additional product candidates that the Company believes to have significant commercial potential through both internal research and development efforts and external collaborations.

Development strategy. Aequus is developing several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. These products combine new delivery technologies, such as transdermal patches, with currently approved medicines that are limited by their current route of delivery.

PRODUCTS

Aequus Pharmaceuticals has a pipeline of commercial and near-commercial-stage products that have been brought in through an acquisition or license to be marketed and sold in Canada. This commercial pipeline consists of specialty products and forms the base for niche therapeutic franchises we plan to expand into it. We will continue to in-license and/or acquire high quality, differentiated products within these focused therapeutic areas. To learn more about our partnering strategy, click here.

Aequus' development-stage products are strategically focused on addressing the need for improved medication adherence through enhanced delivery systems. Our lead programs are expected to follow a 505(b)2 pathway to approval in the United States. We intend to commercialize these products directly in Canada using our established CNS sales force and through partners in other territories.

Tacrolimus Immediate Release
Aequus began promotional activities on Tacrolimus IR in December 2015. It was and remains the only lower cost alternative to the brand Prograf® currently marketed in Canada. Tacrolimus IR is indicated for the treatment and prevention of acute rejection following solid organ transplantation (liver, kidney and heart). Tacrolimus is part of a patient’s immunosuppressive therapy prescribed chronically in their lifelong management to prevent graft rejection.

PRVISTITANTM - (bimatoprost 0.03%, ophthalmic solution)
Bimatoprost 0.03% is a prostaglandin approved for the reduction of elevated IOP in patients with open angle glaucoma or ocular hypertension. PRVISTITANTM is currently the only marketed version of 0.03% bimatoprost ophthalmic solution for this indication in Canada and demonstrates that best ratio of safety to efficacy for this strength of the molecule.
Zepto® Precision Pulse Capsulotomy System

The Zepto capsulotomy system provides consistent, high quality anterior lens capsulotomies during cataract surgery in a convenient, cost-effective, disposable format. Zepto integrates seamlessly into the routine steps of cataract surgery with phacoemulsification. Zepto’s unique single use hand piece can be inserted through incisions as small as 2.2mm, to create a perfectly circular and precisely placed capsulotomy that can be centered on the visual axis. Zepto is ideal for surgery using premium lenses as well as difficult cases and creates a capsulotomy with an edge strength greater than conventional methods or femtosecond lasers.

Topiramate XR
A once-daily topiramate product designed to improve patient compliance and to show an equivalent pharmacokinetic profile than the currently available immediate release products, which is dosed twice-daily. Aequus in-licensed Canadian commercial rights to Topiramate XR from Supernus Pharmaceuticals and is currently preparing an application to Health Canada seeking approval. Topiramate immediate release is currently approved in Canada for use in epilepsy and prophylactic migraine.

Oxcarbazepine XR
A once-daily oxcarbazepine product designed to improve patient compliance with a novel pharmacokinetic profile and more consistent blood levels compared to immediate release products. Aequus in-licensed Canadian commercial rights to Oxcarbazepine XR from Supernus Pharmaceuticals and is currently preparing an application to Health Canada seeking approval. Oxcarbazepine immediate release is currently approved in Canada for use in partial seizures in epilepsy.

AQS1301 – Transdermal Aripiprazole
Aripiprazole is an atypical anti-psychotic sold under the brand name Abilify® and is approved for many neurological conditions including schizophrenia, bipolar I, and major depressive disorder. A long-acting transdermal form of aripiprazole is being developed by Aequus to deliver aripiprazole at levels comparable to currently marketed once-daily formulations with the intention of improving patient compliance and providing better outcomes. Aequus has completed two-proof of concept studies for this potential product to date, and intends to pursue a 505(b)2 pathway for regulatory approval in the United States.

AQS1303 – Transdermal Pyridoxine/Doxylamine
Pyridoxine/doxylamine is currently marketed as Diclegis® (United States)/Diclectin® (Canada) for the treatment of Nausea and Vomiting of Pregnancy. It is taken orally, dosed up to four times per day. A long-acting transdermal form of pyridoxine/doxylamine is being developed by Aequus to address the risk of missed doses due to emesis (vomiting), provide consistent symptomatic relief, ease pill burden, and improve compliance. Aequus is preparing for its first Proof of Concept study for this product, and intends to pursue a 505(b)2 pathway for regulatory approval in the United States.

AQS1304 – Transdermal Medical Cannabis
Medical cannabis is lacking in three main categories - dose delivery, dose consistency, and clinical data support. Aequus’ cannabinoid transdermal patch program is being developed to directly address these barriers. Throughout development Aequus will be working closely with patients and physicians with the goal to provide a cannabinoid product that is safe, consistent, targeted, and effective.

With multiple successful product launches and over $1bn in financing history, Aequus’ management has a strong ability to execute on commercial strategy. The team consists of former investment bankers and pharmaceutical executives who have extensive experience financing and advancing companies in the life sciences.

MANAGEMENT

Doug Janzen
CHAIRMAN & CHIEF EXECUTIVE OFFICER
Doug Janzen has been involved in the Life Sciences industry for the past 19 years. He is currently the Founder and President of Northview Ventures, an organization which invests in and provides strategic advisory services to a number of technology companies. Mr Janzen was part of the founding group of Aequus Pharmaceuticals. Previously, Mr Janzen was President and CEO of Cardiome Pharma, a NASDAQ listed drug development company that raised over $300 million from investors, and completed over $1 billion in licensing deals during his tenure. In 2010, Cardiome’s lead product, Brinavess, was approved and launched in Europe by Merck. Prior to that, he was an investment banker with Cormark Securities, acting as Managing Director of Life Sciences. Mr Janzen is Past Chair of LifeSciences BC, has served as a Director with Biotech Canada and currently sits as a Director on a number of public and private boards. He is a past winner of Business in Vancouver’s Top 40 Under 40 Award.

Anne Stevens, BSc, MHA
CHIEF OPERATING OFFICER & DIRECTOR
Ms Stevens has over ten years of progressive experience in the Pharmaceutical, Biotech, and Medical Device industry. Anne is the Co-Founder and Senior Partner of Northview Ventures, an entity which invests in and provides strategic advisory services to a number of life sciences companies. Ms Stevens was part of the founding group of Aequus Pharmaceuticals and previously held the title of VP of Corporate Development. Prior to her involvement with Aequus, Ms Stevens served as the Corporate and External Affairs Analyst for Cardiome Pharma, where she was responsible for strategic planning and value analysis of internal R&D. Ms Stevens’ earlier experience includes 5 years with Bayer HealthCare, where she was responsible for the commercial success and business development of a portfolio of products within several key therapeutic areas.

Ian Ball
CHIEF COMMERCIAL OFFICER
Ian joined the Pharma industry in 1995 and has spent the last 20 years in various sales and marketing roles for multinational companies. His experience is unique; an experienced General Manager across multiple territories, a top rated medical representative, award winning marketer, recognized expert in commercial supply chain within Pharma and an industry leader in parallel trade management. Ian has led Board level initiatives in Novartis and consulted with other Pharma companies on portfolio management and commercial strategy.

Ian’s most recent role was as CEO of TeOra Health, a specialty pharma company with a focus on Ophthalmology and Transplant which was acquired by Aequus Pharmaceuticals Inc.

Donald McAfee, PhD
CHIEF SCIENTIFIC OFFICER
Dr. McAfee has been a scientist and manager in academia and industry for more than 40 years. Most recently, he was Cardiome Pharma’s Chief Scientific Officer after serving as Vice President of New Product Development since 2004. Previously, he was Founder, Chief Executive Officer, and Chief Technical Officer of Aderis Pharmaceuticals, Inc. where he led the introduction of a number of clinical candidates including a therapeutic patch for Parkinson’s disease, now marketed.

Ann Fehr, CPA, CGA
CHIEF FINANCIAL OFFICER
Ms. Fehr is the Principal at Fehr & Associates, and has held a number of senior level positions including having served as CFO of Carrus Capital Corporation (formerly BioWest Therapeutic Inc.), Global Minerals Ltd., and other companies listed on the TSX. During the course of her management and consulting career, Ms. Fehr has led a number of companies through significant change and corporate milestones such as public listing applications, mergers and acquisitions, as well as strategic planning and execution. Ms. Fehr is also an active volunteer in the community. Since 2013, she has been Treasurer and a Director for the Boys and Girls Clubs of South Coast BC.

SOURCE: http://www.aequuspharma.ca/en/

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