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GIMOTI® Commercialization Update

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Evoke Pharma, Inc.
Evoke Pharma, Inc.

New Research Study Demonstrates Increased Acceptance Among Healthcare Providers

Patient Testimonial Videos Detail Benefits Included and Available on GimotiRx.com

Expanded Coverage with recent New York Medicaid Approval

SOLANA BEACH, Calif., Feb. 17, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced positive outcomes from an additional research study conducted for GIMOTI® (metoclopramide) nasal spray. The study’s objective was to assess the overall awareness of and familiarity with GIMOTI across a broad spectrum of healthcare providers. The company also announced the availability of recently recorded patient testimonial videos and a recent positive insurer decision for New York State Medicaid.

Research Study

In December 2021, Evoke’s commercialization partner EVERSANA conducted a GIMOTI Awareness, Trial, and Usage (ATU) Study to gauge continued physician and provider awareness, trial, and utilization of GIMOTI following market developments in the second half of 2021. Similar to previous studies, this survey was divided into four sections: the current treatment approach, recent prescribing behavior, treatment awareness, and additional perspectives around support resources.

The survey participant population of 135 respondents was comprised of 65 gastroenterologists (GIs) targeted by Evoke sales professionals, 25 non-target GIs, 25 non-target primary care physicians (PCP), and 20 non-target GI-affiliated nurse practitioners (NPs) and physician assistants (PAs).

Key findings from the survey include:

  • Steady increase in intent to prescribe GIMOTI

    • 88% of all respondents intend to prescribe GIMOTI

      • 92% of targeted GIs compared to 90% in previous study

      • 92% of non-targeted GIs compared to 86% in previous wave

      • 80% of PCPs compared to 100% in previous study

      • 89% of NP/PAs; increased sample size since previous study

  • Increase in proportion of patients using GIMOTI in any line of therapy

    • Wider acceptance especially among GIs as first-line usage for patients with severe gastroparesis

    • Greater usage of GIMOTI as third-line therapy showing significant increase by GIs of 33.3% from previous waves

  • Scored higher familiarity rates among all GIs and NPs/PAs; over 80% of target and non-target GI respondents show robust awareness of GIMOTI

  • Respondents across all segments perceive an oral tablet as the least effective route of administration

Patient Testimonials

“These research studies have continued to validate our commercial strategy, campaign, and tactics. Beyond the quantitative aspects, we are pleased to see the increasing preference for GIMOTI’s novel nasal route of administration versus traditional oral treatment methods. This observation reinforces our commitment to redefining the gastroparesis treatment landscape,” commented David Gonyer, R.Ph., Evoke Pharma President and CEO. “We continue to hear from patients and physicians about the benefits of GIMOTI and are actively capturing their feedback in market research and testimonial videos.”

Patient testimonial video: https://www.gimotirx.com/

“Diabetic gastroparesis can be difficult to treat given the disease itself can limit effectiveness of oral treatments. Orally administered medications can be blocked by the faulty stomach or vomited due to the symptoms often experienced by patients,” stated Dr. Fred C. Fowler, M.D., gastroenterologist and founding member of Carolina Digestive Health Associates in Charlotte, NC. ”Having a non-oral alternative like GIMOTI allows rapid delivery of a medication that bypasses the stomach to lessen symptoms such as abdominal pain, nausea and vomiting.”

GIMOTI Coverage

Evoke and Eversana continue to introduce the benefits of GIMOTI to various public and private insurers. Recently, GIMOTI has been added to the New York State Medicaid program for coverage requiring only proof of diabetes diagnosis.

“We continue to make strides across many aspects of commercialization such as brand awareness, patient successes and insurer coverage,” added Chris Quesenberry, GIMOTI Chief Commercial Officer. “We look forward to capitalizing on this information and encouraging providers to prescribe GIMOTI for appropriate patients to alleviate the symptoms associated with diabetic gastroparesis.”

GIMOTI® Patient Corner (Multimedia)

Since we introduced GIMOTI to the market in 2020, we have proactively gathered patient testimonials about their experience with GIMOTI and the difference it is making for them and their families. We encourage you to view a few real-life patient testimonials on GIMOTI and its game-changing effects: https://www.gimotirx.com/.

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. Visit www.EvokePharma.com for more information.

Follow GIMOTI on Facebook: https://www.facebook.com/GIMOTI-metoclopramide-nasal-spray-104672345100289

Follow Evoke Pharma on Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724

Follow Evoke Pharma on LinkedIn: https://www.linkedin.com/company/evoke-pharma/

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.

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: potential future prescribing trends for GIMOTI based on this survey of GIs and PCPs or Evoke’s marketing efforts; and Evoke’s commercialization plans, including its plans to increase awareness and access to GIMOTI. 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 and EVERSANA’s ability to successfully drive market demand for GIMOTI; the results of the ATU survey may not predict prescribing trends by doctors or acceptance by patients, and are not intended to reflect or imply actual prescriptions or sales to date; Evoke’s ability to obtain additional financing as needed to support its operations; the COVID-19 pandemic may continue to disrupt Evoke’s and EVERSANA’s business operations impairing the ability to commercialize GIMOTI and Evoke’s ability to generate any product revenue; 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; 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-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net