Evoke Pharma Enters Agreement with Rho to Submit NDA for Gimoti
Company on track for late 2017/early 2018 submission
SOLANA BEACH, CA, May 31, 2017 – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has entered into an agreement with Rho, Inc., a regulatory consulting and contract research organization (CRO). Rho will assist Evoke with the preparation and submission of its planned 505(b)(2) New Drug Application (NDA) for Gimoti™, the Company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
“We are actively laying the necessary groundwork to submit an NDA package for Gimoti to the U.S. Food and Drug Administration (FDA). We believe that it was imperative to select a CRO with relevant experience to optimize the chance of a successful submission leading to approval for Gimoti,” stated Dave Gonyer, R.Ph. President and CEO. “Rho has worked on other successful NDA submissions that have led to FDA approval of GI products, and we look forward to leveraging the experience of their dedicated team in the preparation of our application. In parallel, we remain on track to initiate and complete our PK study in the second half of this year with our NDA submission by late 2017 or early 2018.”
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.
About Rho, Inc.
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a broad range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies, as well as academic and government organizations.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: Evoke’s plans to prepare and submit the Gimoti NDA with Rho’s assistance; and the timing of the NDA submission, if any. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke's business, including, without limitation: risks associated with successfully commencing and receiving favorable results from the planned PK study; later developments with the Food and Drug Administration (FDA) that may be inconsistent with the already completed pre-new drug application (NDA) meetings, including inconsistent conclusions reflected in the official meeting minutes from the FDA; the inherent risks of clinical development of Gimoti; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that it will be able to submit an NDA for Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; risks associated with manufacturing new formulations of Gimoti for use in the PK trial; Evoke’s dependence on third parties for the manufacture of Gimoti as well as the conduct of the PK trial; Evoke’s dependence on Rho to assist with the NDA submission; Evoke may require additional funding to complete the PK trial and submit the NDA, and will require substantial additional funding to commercialize Gimoti, and may be unable to raise capital when needed, including to fund ongoing operations; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.