Evoke Pharma Receives Notice of Allowance from USPTO for GIMOTI®
September 14 2023 - 7:30AM
Evoke Pharma, Inc. (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 StatementEvoke 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:Daniel Kontoh-BoatengDKB
PartnersTel: 862-213-1398dboateng@dkbpartners.net
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