Evoke Pharma Receives Notice of Allowance from USPTO for GIMOTI®

SOLANA BEACH, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) --  (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI^® (metoclopramide) nasal spray, announced that it has been granted a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application No. 17/366,829 pertaining to GIMOTI, the first and only FDA-approved nasal formulation of metoclopramide commercially available in the United States. When issued, the patent will cover the intranasal pharmaceutical composition of GIMOTI.

Upon issuance, the patent titled “Nasal Formulations of Metoclopramide” will be set to expire in 2029. Based on market, healthcare provider (HCP), and patient surveys, GIMOTI has demonstrated a meaningful reduction in utilization of healthcare resources and presents a novel solution to diabetic gastroparesis treatment by delivering a non-oral dose of metoclopramide to relieve symptoms in adults associated with this disease. GIMOTI has been commercially available in the United States since 2020 and is currently prescribed by over a thousand HCPs nationwide.

“This soon-to-issued patent further establishes our commercial and intellectual property footprint within the GI therapeutic space. We continue to hear stories of lives being changed with GIMOTI and we believe our product can become the first-line treatment for those who suffer from the debilitating symptoms of diabetic gastroparesis. This disease continues to grow due to the increase in prevalence of diabetes and we are receiving significant market feedback regarding the implications of the new GLP-1 treatments which may uncover delayed gastric emptying. Diabetes and gastroparesis (delayed gastric emptying) remains our focus and GIMOTI is the only non-oral outpatient treatment indicated to address the nausea, vomiting, abdominal pain and other symptoms brought on by this difficult disease,” commented David Gonyer, R.Ph., Chief Executive Officer of Evoke Pharma.

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.

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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 anticipated scope and term of any patent protection for GIMOTI; GIMOTI’s potential to reduce healthcare resource utilization by diabetic gastroparesis patents; and Evoke’s belief that GIMOTI can become a first-line treatment and otherwise improve treatment of diabetic gastroparesis. 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 ability to obtain, maintain and successfully enforce intellectual property protection for Gimoti; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; the results of market research studies may not predict acceptance by patients, healthcare providers or payors; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke is entirely dependent on the success of GIMOTI; Evoke’s dependence on third parties for the manufacture of GIMOTI; and other risks and uncertainties 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:

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DKB Partners

Tel: 862-213-1398