Evoke Announces Agreement with Mallinckrodt to Amend Milestone Payments
March 26 2018 - 7:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that it has amended the Company’s agreement with
Mallinckrodt, ARD Inc. to defer development and approval milestone
payments for Gimoti™, the Company’s nasal delivery formulation of
metoclopramide for the treatment of symptoms associated with
gastroparesis in women. The amended agreement defers the
amount and timing of two milestone payments due upon U.S. Food and
Drug Administration (FDA) acceptance for review of the New Drug
Application (NDA) and final product marketing approval into a
single milestone payment due one year after FDA approval of the
Gimoti NDA.
“We continue to focus our current resources on
the NDA submission and commercial preparation of Gimoti and
appreciate Mallinckrodt’s support of Evoke and our intent to bring
Gimoti to market. This deferral provides us additional available
capital. We have now improved our cash runway to January of next
year and remain on track to submit the Gimoti NDA next quarter,”
commented Dave Gonyer, President and CEO.
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 GI 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.
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:
anticipated timing to submit an NDA for Gimoti; the potential
timing of FDA approval, if any, of the NDA for Gimoti; and Evoke’s
projected cash runway. 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
may spend its available cash faster than it anticipates; the FDA
may disagree that the existing safety database is sufficient to
allow an NDA submission and approval; risks associated with FDA
review of the final results from the comparative exposure
pharmacokinetic (PK) trial, including the FDA may not agree with
Evoke's interpretation of such results; later developments with the
FDA that may be inconsistent with the already completed pre-NDA
meetings and most recent correspondence; 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; Evoke will require substantial
additional funding to conduct any new safety trials required by the
FDA, 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 GroupTram BuiTel:
646-536-7035tbui@theruthgroup.com
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