Aequus Prepares for Proof of Concept Clinical Study for Transdermal Anti-Nausea Diclegis Program
Vancouver, BC. November 17, 2016 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”) announced today that is has entered into a service agreement with Corium International, Inc. (NASDAQ: CORI) for the manufacturing of clinical trial materials for Aequus’ transdermal doxylamine/pyridoxine long-acting patch, AQS1303. This product is being developed for the treatment of nausea and vomiting of pregnancy (NVP), and is expected to enter into a Proof of Concept clinical trial in the first half of 2017.
Doxylamine/pyridoxine is currently marketed as Diclegis ® (US) / Diclectin ® (Canada) for the treatment of NVP as an oral tablet, dosed up to four times per day and is the only FDA-approved medication to treat this condition. Diclegis ® has demonstrated strong year over year growth since its US launch in 2013, with sales revenues in 2015 exceeding USD$120M. Aequus has engaged with over 400 women who have suffered from nausea and vomiting during their pregnancy to understand the need for an alternate delivery form of doxylamine/pyridoxine, such as an easy to administer transdermal patch. The results from these discussions highlighted the discomfort women experience while taking oral medications to treat their nausea and vomiting symptoms during pregnancy. The majority of women surveyed by Aequus who had been treated medically for either moderate or severe symptoms experienced gag reflex, immediate vomiting following dosing and/or dry-mouth while trying to take their oral medication and expressed a high level of interest in a convenient, transdermal route of delivery.
“Women with severe symptoms who experience vomiting after dosing of their oral therapy are often uncertain as to whether the medication has been absorbed and if taking another dose would be permissible. Transdermal administration of this medication would provide steady-state delivery of the medication, and is expected to provide consistent symptom relief,” said Anne Stevens, COO and Director of Aequus. “We are delighted to be advancing this program to provide patients with a more comfortable and reliable treatment alternative.”
“This is Aequus’ second program to be advanced into a clinical Proof of Concept study, and adds significant value to the development arm of our business,” said Doug Janzen, President and CEO of Aequus. “As we grow into a more mature specialty pharmaceutical company, we remain focused on developing, advancing and promoting products that provide a true benefit to patients.”
The primary objectives for the Proof of Concept study will be to assess the bioavailability, safety and tolerability of Aequus’ once-daily transdermal formulation containing doxylamine succinate and pyridoxine hydrochloride. In parallel to this study, Aequus is preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US. 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.
Aequus owns the exclusive, worldwide rights to the transdermal formulation for AQS1303 and is committed to deriving the maximum value to shareholders from this program by out-licensing commercial rights in certain markets worldwide.
ABOUT AEQUUS PHARMACEUTICALS
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. 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.
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: the expected benefits of AQS1303 and transdermal delivery, the ability of the Company to add significant shareholder value in the near term, and the Company’s intention to commercialize its internal programs in Canada, form strategic partnerships and build its Canadian commercial platform. 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 Company’s ability to protect its intellectual property, the Company’s ability to raise additional funding, existing governmental regulations and changes in, or the failure to comply with, governmental regulations, changes in business strategy or development plans, and the expected benefits of AQS1303 and transdermal delivery. 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.
Diclegis ® and Diclectin ® are registered trademarks of Duchesnay Inc.
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