Evoke Pharma Completes Manufacturing of Commercial Scale Registration Batches of Gimoti™
September 17 2019 - 8:30AM
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that it has completed manufacturing commercial
scale batches of its product candidate Gimoti (metoclopramide nasal
spray) with its partner Thermo Fisher Scientific, a leading global
contract development and manufacturing organization that
specializes in the preparation, fill and finish of nasal spray
products.
Evoke plans to collect Chemistry, Manufacturing
and Controls (CMC) data from these registration batches, which were
requested in the complete response letter (CRL) from the U.S. Food
and Drug Administration (FDA). These data will be used to support
the proposed acceptance criteria for performance characteristics
and device quality control and will be included in Evoke’s planned
resubmission of the 505(b)(2) New Drug Application (NDA) for
Gimoti.
“We are pleased to complete another step toward
commercial readiness with manufacturing at commercial scale while
addressing regulatory requests,” stated Dave Gonyer, President and
CEO. “Based on the meeting minutes from our recent Type A meeting
with FDA, we are now focused on collecting data from these batches
to support our NDA resubmission. Simultaneously, we continue to
prepare the root cause analysis and patient experience data as
requested in the CRL. We remain on track to resubmit a
comprehensive NDA package for Gimoti in the fourth quarter of this
year.”
About
GastroparesisGastroparesis is a debilitating, episodic
condition that disproportionately affects adult women and is
characterized by slow or delayed gastric emptying of the stomach’s
contents after meals, often resulting in flares of symptoms that
include nausea, vomiting, abdominal pain and bloating. Vomiting and
gastric emptying delays can cause unpredictable absorption of food
and oral medications, which complicate glucose control and can lead
to dehydration and malnutrition. These clinical manifestations of
gastroparesis also potentially render existing oral drug treatment
options ineffective. If approved, Gimoti would be the first
non-oral outpatient drug treatment for symptoms associated with
acute and recurrent diabetic gastroparesis in adult women and would
represent the first significant advancement in the treatment of
gastroparesis in 40 years.
About Evoke Pharma, Inc.Evoke
is a specialty pharmaceutical company focused primarily on the
development of drugs to treat Gastrointestinal (GI) disorders and
diseases. The Company is developing Gimoti, a nasal spray
formulation of metoclopramide, for the relief of symptoms
associated with acute and recurrent diabetic gastroparesis in adult
women.
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 digestive
system symptoms. The gastric delay caused by gastroparesis can
compromise absorption of orally administered medications.
Metoclopramide is currently available only in oral and injectable
formulations and is the only drug currently approved in the United
States to treat gastroparesis. Visit www.EvokePharma.com for more
information.
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 use the CMC data from the
registration batches to support the resubmission of the Gimoti NDA;
the addressability of the approvability issues cited by FDA in the
CRL, including with respect to the performance characteristics and
root cause analysis regarding the pharmacokinetic variability; and
the potential for an NDA resubmission in the fourth quarter. 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: the CMC data from the
registration batches may not support the acceptance criteria for
droplet size distribution and other performance characteristics and
device quality control; Evoke may be unable to timely and
successfully address the deficiencies raised in the CRL, including
as a result of adverse findings from a root cause analysis or data
from the completed registration manufactured product batches; FDA
may not agree with Evoke's conclusion of the root cause analysis or
analysis of the CMC data from the registration batches or may
require Evoke to conduct additional studies; the inherent risks of
clinical development of Gimoti; Evoke’s dependence on third parties
for the manufacture of Gimoti and analysis of the PK data; Evoke is
entirely dependent on the success of Gimoti, and Evoke cannot be
certain that FDA will accept or approve an NDA resubmission for
Gimoti; Evoke will require substantial additional funding to
address the deficiencies raised in the CRL, and may be unable to
raise capital or obtain funds when needed, including to fund
ongoing operations; Evoke could face significant additional costs
due to litigation or other events; Evoke’s ability to maintain the
continued listing of its common stock on the Nasdaq Capital Market;
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 GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
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