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 updates regarding their business and commercial
growth strategy. With a determined focus to ensure maximum market
access for GIMOTI, Evoke continues to execute on its plan to expand
net product sales throughout 2024. This update outlines the key
areas of Evoke’s strategic blueprint and positive updates regarding
its implementation.
ASPN Pharmacy Platform
In November 2023, Evoke transitioned its pharmacy distribution
partnership from vitaCare to ASPN Pharmacies. This strategic move
has streamlined the prescription process for healthcare providers,
ensuring that patients receive GIMOTI promptly. Over two quarters
of collaboration with ASPN, Evoke has improved percentages of
GIMOTI prescriptions converted to fills, and initial data show
record-high prescription fills in April and May. ASPN's
comprehensive servicing platform provides holistic advantages for
our business, healthcare providers, and patients, reinforcing
Evoke’s mission to reach as many patients as possible.
“We continue to make inroads into the diabetic gastroparesis
market and believe we are well positioned to improve the health and
daily life of patients suffering with symptoms of this debilitating
disease. We have invested significantly in generating evidence to
demonstrate the value of GIMOTI to patients, providers and payers.
Partnering with ASPN affords Evoke access to state of the art tools
and capabilities and allows us to ensure we can deliver GIMOTI
quickly, improve patient and provider experience and ramp up for
future demand,” said Chris Quesenberry, Chief Commercial Officer
for GIMOTI.
Medicaid access through Pharmacy
Partnerships
In May 2024, Evoke, through Eversana, began expanding our
filling pharmacy network from a single central organization to an
additional four regional pharmacies. This is intended to allow for
improved coverage, reimbursement and speed to deliver GIMOTI to
patients in need. Some of the states where access to GIMOTI will
improve based on expanded distribution include: Arkansas,
Connecticut, Georgia, Illinois, and Michigan, Mississippi, Rhode
Island and Tennessee. In our first full month with these additional
pharmacies, Evoke is already realizing additional GIMOTI covered
prescriptions through insurers, especially Medicaid patients. Evoke
anticipates further expansion of our pharmacy distribution in the
coming months.
“Halfway into 2024, as prescriptions continue to grow, we are
executing on our distribution expansion strategy and are seeing
improved growth trajectory of access and sales for GIMOTI. The
combination of the shift to ASPN and the expansion of additional
regional pharmacies is yielding results to help unlock GIMOTI's
true market potential,” stated Matt D’Onofrio, Chief Executive
Officer of Evoke Pharma.
Leadership Changes and Operational
Enhancements
In alignment with Evoke’s growth objectives, we are pleased to
announce the promotion of Mark Kowieski, formerly our VP of
Finance, to the role of Chief Financial Officer in May 2024. Mark
brings a wealth of financial and public accounting experience and a
deep understanding of Evoke Pharma’s operations to the role, which
are instrumental in enhancing our operational efficiency and
driving excellence.
Evoke is committed to maintaining a lean business model to
maximize value for our stakeholders. Mark’s promotion is a key part
of our plan to streamline operations and reduce overhead costs
while accelerating growth.
Mark Kowieski, newly appointed Chief Financial Officer of Evoke
Pharma, commented, “I am thrilled to assume the role of CFO at
Evoke Pharma during this pivotal time in our company’s commercial
journey. With the robust support from Eversana and the expertise of
our leadership team and board, I am confident that we have all the
necessary tools to drive significant business growth. Our focus
remains on accelerating revenue growth, ensuring GIMOTI is
accessible to all patients in need, and ultimately generating
substantial value for our shareholders.”
The company will report full results for sales in the second
quarter in August 2024.
About Gimoti® (metoclopramide) nasal spray
GIMOTI is indicated for the relief of symptoms in adults with
acute and recurrent diabetic gastroparesis. Important Safety
Information
WARNING: TARDIVE DYSKINESIA
- Metoclopramide can cause tardive
dyskinesia (TD), a serious movement disorder that is often
irreversible. The risk of developing TD increases with duration of
treatment and total cumulative dosage.
- Discontinue GIMOTI in patients who
develop signs or symptoms of TD. In some patients, symptoms may
lessen or resolve after metoclopramide is stopped.
- Avoid treatment with metoclopramide
(all dosage forms and routes of administration) for longer than 12
weeks because of the increased risk of developing TD with
longer-term use.
GIMOTI is not recommended for use in:
- Pediatric patients due to the risk
of developing tardive dyskinesia (TD) and other extrapyramidal
symptoms as well as the risk of methemoglobinemia in neonates.
- Moderate or severe hepatic
impairment (Child-Pugh B or C), moderate or severe renal impairment
(creatinine clearance less than 60 mL/minute), and patients
concurrently using strong CYP2D6 inhibitors due to the risk of
increased drug exposure and adverse reactions.
GIMOTI is contraindicated:
- In patients with a history of
tardive dyskinesia (TD) or a dystonic reaction to
metoclopramide.
- When stimulation of gastrointestinal
motility might be dangerous (e.g., in the presence of
gastrointestinal hemorrhage mechanical obstruction, or
perforation).
- In patients with pheochromocytoma or
other catecholamine-releasing paragangliomas. Metoclopramide may
cause a hypertensive/pheochromocytoma crisis, probably due to
release of catecholamines from the tumor.
- In patients with epilepsy.
Metoclopramide may increase the frequency and severity of
seizures.
- In patients with hypersensitivity to
metoclopramide. Reactions have included laryngeal and glossal
angioedema and bronchospasm.
Potential adverse reactions associated with metoclopramide
include: Tardive dyskinesia (TD), other extrapyramidal effects
(EPS), parkinsonism symptoms, motor restlessness, neuroleptic
malignant syndrome (NMS), depression, suicidal ideation and
suicide, hypertension, fluid retention, hyperprolactinemia, effects
on the ability to drive and operate machinery. Most common adverse
reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue.
These are not all of the possible side effects of GIMOTI. Call your
doctor for medical advice about whether you should take GIMOTI and
the possible risk factors and side effects. You are encouraged to
report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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.
About EVERSANA
EVERSANA™ is the leading independent provider of global services
to the life sciences industry. The company’s integrated solutions
are rooted in the patient experience and span all stages of the
product life cycle to deliver long-term, sustainable value for
patients, prescribers, channel partners and payers. The company
serves more than 500 organizations, including innovative start-ups
and established pharmaceutical companies, to advance life sciences
solutions for a healthier world. To learn more about EVERSANA,
visit eversana.com or connect
through LinkedIn and Twitter.
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
strategy of adding pharmacies to its prescribing platform to drive
additional sales; Evoke’s commercialization plans, including the
initial data showing that the prescription fills in April and May
2024 are record-highs for the company; and that Evoke is
successfully executing on its commercial strategy and may generate
stockholder value. 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 not be able to achieve increased revenues for 2024; Evoke’s and
EVERSANA’s ability to successfully drive market demand for GIMOTI;
Evoke may not be able to regain compliance with Nasdaq’s minimum
bid price requirement or maintain compliance with Nasdaq’s minimum
stockholders’ equity requirements which may result in the Evoke’s
common stock being delisted from Nasdaq; Evoke’s ability to obtain
additional financing as needed to support its operations; Evoke may
use its capital resources sooner than expected; warrant holders may
choose not to exercise any of the outstanding warrants; Evoke’s
dependence on third parties for the manufacture of GIMOTI; Evoke is
entirely dependent on the success of GIMOTI; inadequate efficacy or
unexpected adverse side effects relating to GIMOTI that could
result in recalls or product liability claims; Evoke’s ability to
maintain intellectual property protection for 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 & Media Contact:Daniel
Kontoh-BoatengDKB PartnersTel:
862-213-1398dboateng@dkbpartners.net
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