Evoke Pharma Enters Agreement with Rho to Submit NDA for Gimoti
May 31 2017 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that it has entered into an agreement with Rho,
Inc., a regulatory consulting and contract research organization
(CRO). Rho will assist Evoke with the preparation and submission of
its planned 505(b)(2) New Drug Application (NDA) for Gimoti™, the
Company’s patented nasal delivery formulation of metoclopramide for
the relief of symptoms associated with acute and recurrent diabetic
gastroparesis in adult women.
“We are actively laying the necessary groundwork
to submit an NDA package for Gimoti to the U.S. Food and Drug
Administration (FDA). We believe that it was imperative to select a
CRO with relevant experience to optimize the chance of a successful
submission leading to approval for Gimoti,” stated Dave Gonyer,
R.Ph. President and CEO. “Rho has worked on other successful NDA
submissions that have led to FDA approval of GI products, and we
look forward to leveraging the experience of their dedicated team
in the preparation of our application. In parallel, we remain on
track to initiate and complete our PK study in the second half of
this year with our NDA submission by late 2017 or early 2018.”
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 is developing Gimoti, a metoclopramide
nasal spray for the relief of symptoms associated with acute and
recurrent gastroparesis in women with diabetes mellitus. Diabetic
gastroparesis is a disorder afflicting millions of sufferers
worldwide, in which the stomach takes too long to empty its
contents resulting in serious digestive system symptoms.
Metoclopramide is the only product currently approved in the United
States to treat gastroparesis, and is currently available only in
oral and intravenous forms. Gimoti is a novel formulation of this
drug, designed to provide systemic delivery of metoclopramide
through nasal administration. Visit www.EvokePharma.com for
more information.
About Rho, Inc.
Rho, a privately-held, contract research
organization (CRO) located in Chapel Hill, NC, provides a broad
range of clinical research services across the entire drug
development process. For more than 32 years, Rho has been a trusted
partner to some of the industry’s leading pharmaceutical,
biotechnology, and medical device companies, as well as academic
and government organizations.
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: Evoke’s
plans to prepare and submit the Gimoti NDA with Rho’s assistance;
and the timing of the NDA submission, if any. 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: risks associated with
successfully commencing and receiving favorable results from the
planned PK study; later developments with the Food and Drug
Administration (FDA) that may be inconsistent with the already
completed pre-new drug application (NDA) meetings, including
inconsistent conclusions reflected in the official meeting minutes
from the FDA; the inherent risks of clinical development of Gimoti;
Evoke is entirely dependent on the success of Gimoti, and
Evoke cannot be certain that it will be able to submit an NDA for
Gimoti or obtain regulatory approval for or successfully
commercialize Gimoti; risks associated with manufacturing
new formulations of Gimoti for use in the PK trial; Evoke’s
dependence on third parties for the manufacture of Gimoti as well
as the conduct of the PK trial; Evoke’s dependence on Rho to assist
with the NDA submission; Evoke may require additional funding to
complete the PK trial and submit the NDA, and will require
substantial additional funding to commercialize Gimoti, and may be
unable to raise capital when needed, including to fund ongoing
operations; 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
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Apr 2023 to Apr 2024