GlobeNewswire Inc | Jun 8, 2021 08:30AM EDT

June 08, 2021

SOLANA BEACH, Calif., June 08, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that its US patent No. 11,020,361 for Gimoti (metoclopramide) nasal spray is now listed in the U.S. Food and Drug Administration (FDA) publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The patent covers methods of use for nasal delivery of metoclopramide for the treatment of gastroparesis.

Gimoti is Evokes nasal spray product for the relief of symptoms in acute and recurrent diabetic gastroparesis. FDA approved the New Drug Application for Gimoti in June 2020. As previously announced on June 2, 2021, the United States Patent and Trademark Office (USPTO) issued US patent No. 11,020,361 entitled Nasal Formulations of Metoclopramide for Gimoti. This new patent is now listed in the FDAs Orange Book and carries a patent term to at least 2029.

We are pleased to expand and strengthen our intellectual property protection for Gimoti through the listing of our latest patent in the FDAs Orange Book, commented David Gonyer, President and Chief Executive Officer of Evoke Pharma. We firmly believe Gimoti, as the first and only outpatient non-oral treatment option for gastroparesis, offers an innovative option for treating patients that have erratic absorption of oral medications. We are excited to protect our technology for Gimotis method of use and look forward to continuing our mission to improve the quality of life for patients suffering from diabetic gastroparesis.

Patents listed in the Orange Book cover drugs that the FDA has approved and deemed both safe and effective for the general publics use. Inclusion in the books list of patents can make it easier for drug makers to monitor for new generic drugs that could potentially arrive on the U.S. market and infringe on their patents.

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, commercialized and markets 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.

Follow Gimoti on Facebook: https://www.facebook.com/Gimoti-metoclopramide-nasal-spray-104672345100289.

Follow Evoke Pharma on Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724

Follow Evoke Pharma on LinkedIn: https://www.linkedin.com/company/evoke-pharma/

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 companys current beliefs and expectations. These forward-looking statements include statements regarding: Evokes expectations on the scope of any patent protection for Gimoti. 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 Evokes business, including, without limitation: Evokes ability to obtain, maintain and successfully enforce intellectual property protection for Gimoti; Evokes and EVERSANAs ability to successfully drive market demand for Gimoti; Evokes ability to obtain additional financing as needed to support its operations; the COVID-19 pandemic may continue to disrupt Evokes and EVERSANAs business operations impairing the ability to commercialize Gimoti and Evokes ability to generate any product revenue; Evokes 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 result in recalls or product liability claims;; and other risks and uncertainties detailed in Evokes 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 ContactsThe Ruth GroupChristine Petraglia / James SaliernoTel: 917-633-8980 / 973-255-8361cpetraglia@theruthgroup.com / jsalierno@theruthgroup.com

Media Contact:The Ruth GroupAnnika ParrishTel: 720-412-9042aparrish@theruthgroup.com