Evoke Pharma Initiates Commercial Manufacturing of Gimoti™
“We have continued to accelerate the necessary pre-commercialization activities for Gimoti alongside our commercial and manufacturing partners,” said
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company developed GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in
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: the timing of completing the commercial manufacturing of Gimoti and other pre-commercialization activities; the timing of the commercial launch of Gimoti and commercial activities to be conducted by EVERSANA; and the size of the gastroparesis market and the potential of Gimoti to provide an important new alternative to current treatment options. 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: Evoke’s and Patheon’s ability to successfully complete the commercial manufacturing of Gimoti; Evoke’s and EVERSANA’s ability to successfully launch and drive market demand for Gimoti and the timing thereof; Evoke’s ability to obtain additional financing as needed to support its operations, including through its existing line of credit with EVERSANA which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke’s, Patheon’s and EVERSANA’s business operations impairing the ability to manufacture or commercialize Gimoti and Evoke’s ability to generate any product revenue; Evoke’s dependence on third parties for the manufacture of Gimoti; Evoke is entirely dependent on the success of Gimoti; inadequate efficacy or unexpected adverse side effects relating to Gimoti that could delay or prevent commercialization, or that could result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for Gimoti; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the
Source: Evoke Pharma, Inc.