Evoke Pharma Initiates Commercial Manufacturing of Gimoti™
Evoke Pharma, Inc. (NASDAQ: EVOK) has commenced the commercial manufacturing of Gimoti™ (metoclopramide) nasal spray with manufacturing partner Patheon. Approved by the FDA on June 19, 2020, Gimoti is intended for adults suffering from diabetic gastroparesis. The company plans to launch sales in Q4 2020 in collaboration with EVERSANA. CEO David Gonyer emphasized the acceleration of pre-commercialization activities, ensuring the timely completion of manufacturing ahead of the launch.
- Initiated commercial manufacturing of Gimoti nasal spray.
- FDA approval for Gimoti received on June 19, 2020.
- Plans to launch sales in Q4 2020 with partner EVERSANA.
- Dependence on successful commercialization and market demand for Gimoti.
- Potential disruptions in operations due to COVID-19.
- Risks of inadequate efficacy or adverse side effects affecting commercialization.
SOLANA BEACH, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has initiated the commercial manufacturing of Gimoti™ (metoclopramide) nasal spray with its manufacturing partner, Patheon, a division of Thermo Fisher Scientific, Inc. Gimoti was approved by the U.S. Food and Drug Administration on June 19, 2020 for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The Company plans to launch sales of Gimoti in the fourth quarter 2020 with its partner EVERSANA.
“We have continued to accelerate the necessary pre-commercialization activities for Gimoti alongside our commercial and manufacturing partners,” said David Gonyer, R.Ph., President and CEO. “Together with Patheon, we have initiated manufacturing process for the first commercial batch of Gimoti. We expect these activities to be completed over the next several weeks and ahead of our planned launch in the fourth quarter of 2020.”
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 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 the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.
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 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.
Investor Contact:
The Ruth Group
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
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