VANCOUVER, BC--(Marketwired - October 03, 2016) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (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 entered into a service agreement with Camargo Pharmaceutical Services, LLC ("Camargo"). Camargo will be providing end-to-end regulatory consulting services for Aequus' three development programs, including pre-Investigational New Drug (pre-IND) meeting planning and preparations through to New Drug Applications (NDA) submissions. Under the terms of the agreement, Camargo will be compensated with a split of cash and common shares of the Company for the services provided. Subject to the approval of the TSX Venture Exchange, the Company will issue 133,043 common shares of the Company to Camargo in connection with the execution of the agreement.
Camargo is the most experienced global strategist specializing in drug and combination product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with the 505(b)(2) IND and NDA preparations and submissions. The Camargo team includes former FDA team leaders and some of the top regulatory staff in the world, and have guided more than 200 FDA NDA and ANDA approvals.
"Camargo has an impressive history with 505(b)(2) programs, reflected in the number of successful approvals of reformulated products guided by their efforts," said Anne Stevens, Chief Operating Officer of Aequus. "Together, we will be pursuing a clinical path based on studies that are relatively short in duration of treatment and provide a development path that is substantially less costly and more streamlined compared to standard clinical development programs."
"We are pleased that Camargo expressed interest in earning a portion of their consulting fees in Aequus equity, representing the confidence that our regulatory partners have in the outcome of our combined efforts," said Doug Janzen, Chairman and CEO of Aequus. "By partnering with Camargo in this way, we can advance our regulatory strategy in the US with an invested partner whose vast experience will help us secure an efficient and de-risked clinical path forward," said Mr. Janzen. The total value of common shares to be issued to Camargo over the scope of this project is expected to be approximately USD$192,000 in milestone payments.
Camargo will be developing the US regulatory strategy for Aequus' three development programs: a once-weekly transdermal patch for aripiprazole for the intended use in certain psychiatric disorders, a long-acting transdermal patch for clobazam for the intended use in epilepsy, and a long-acting transdermal patch combining doxylamine and pyridoxine for the intended use in nausea and vomiting associated with pregnancy. Camargo and Aequus expect to have pre-IND meetings with the FDA as each of these programs advance through Proof of Concept clinical trials.
"At Camargo, our goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway in order to deliver patient benefits, while driving commercial success for our client-partners," said Ken Phelps, President and CEO of Camargo Pharmaceutical Services. "We look forward to working with Aequus to advance their three programs."
The agreement between Aequus and Camargo is subject to TSX-V approval. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Aequus Pharmaceuticals Inc. (TSX VENTURE: 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, psychiatry and women's health 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 number of common shares of the Company to be issued to Camargo; the clinical paths to be pursued by the Company and Camargo and the expected benefits thereof; the Company's expectations regarding pre-IND meetings with the FDA; the intended uses of the Company's three development programs; 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: 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 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.