GlobeNewswire Inc | Apr 6, 2021 08:30AM EDT

April 06, 2021

SOLANA BEACH, Calif., April 06, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance to Evoke for U.S. Application No. 16/181,841 for Gimoti (metoclopramide) nasal spray. When granted, the patent will cover methods of use for nasal delivery of metoclopramide for the treatment of gastroparesis. The patent, entitled Nasal Formulations of Metoclopramide, carries a patent term to at least 2029. Gimoti is Evokes nasal spray product for the relief of symptoms in acute and recurrent diabetic gastroparesis. The U.S. Food and Drug Administration (FDA) approved the New Drug Application for Gimoti in June 2020. This new patent covers Gimoti for gastroparesis and will be listable in FDAs Orange Book.

We are pleased with this additional USPTO determination that Gimoti is innovative and novel. We believe Gimoti provides an important option for treating diabetic gastroparesis patients with nasal delivery, especially as the disease can cause patients to experience delayed digestion of oral medications, commented Dave Gonyer, President and CEO. The issuance of this Notice of Allowance strengthens the intellectual property protection for Gimoti and will provide another Orange Book-listable patent and a significant addition to our intellectual property estate and overall marketing strategy for Gimoti.

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the commercialization and 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.

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 Evokes current beliefs and expectations. These forward-looking statements include statements regarding Evokes expectations on the scope of any patent protection. 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 associated Evokes ability to obtain and maintain intellectual property protection for GIMOTI and other risks and uncertainties inherent in Evokes business, including those described in Evokes periodic filings with the SEC. 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