Evoke Pharma and EVERSANA Announce Positive Findings from Second GIMOTI® Market Research Study

SOLANA BEACH, Calif. and CHICAGO, June 15, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, a leading provider of global commercial services to the life science industry, today announced positive findings from a second market research study conducted for GIMOTI^® (metoclopramide) nasal spray. The study aimed to gather further market insights on the perception of GIMOTI in the GI community and follows the initial market research study conducted in December 2020. The Company will discuss the findings in roundtable discussions at the upcoming GI ReConnect Conference, a leadership summit for sharing the most current information on GI health, being held on June 18-19^th in Napa Valley, CA.

In May 2021, Evoke’s commercialization partner, EVERSANA, conducted the GIMOTI Awareness, Trial, Usage (ATU) Study, a quantitative survey designed to measure physician awareness, trial, and product usage of GIMOTI. The ATU survey was divided into four sections: the current approach to treating diabetic gastroparesis (DGP), prescribing behavior, treatment awareness, and additional perspectives around support resources.

The respondent mix included 67 gastroenterologists (GIs) currently being called on by the field sales force, and an additional 50 GIs and primary care physicians (PCPs), who are not currently targeted for in person messaging, but whom may be targeted through our online digital and social campaign. The study objectives were to understand the current gastroparesis treatment landscape and to evaluate physicians’ perceptions of GIMOTI following recent brand marketing efforts.

The study results consisted of 117 physician responses. Key findings, including select data point comparisons from the previous ATU Study conducted in December 2020, are outlined below.

Key Findings:

• Continued increase in intent to prescribe GIMOTI:
  - 81% of all respondents intend to prescribe GIMOTI in the future
  • 90% of targeted GIs; compared to 79% in previous study
  • 56% of non-targeted GIs; compared to 89% in previous study
  • 84% of PCPs; compared to 50% in previous study
    
• Targeted GIs report greater GIMOTI usage across first, second and third lines of treatment from the December 2020 study, with the most significant increase as a third-line treatment option from 16% to 24%.
  
• Similar to the previous study, GIs indicated a moderate-to-high level of concern about a diabetic gastroparesis patient’s ability to absorb oral medications, and estimated 20%-40% of their patients may experience this difficulty.
• The percentage of targeted GIs reporting high awareness of GIMOTI (scoring a 4 or 5 out of 5) has increased from 21% in December 2020 to 46% in May 2021.
• More than twice as many (47 versus 19) respondents reported that they have written a prescription for GIMOTI in the previous two months compared to the previous study.
• Targeted GIs report increased in-person visits by sales representatives. Importantly 75% of target GIs stated they would prefer future interactions to be in-person vs 64% in the previous study.
  

“We are encouraged by the latest ATU study findings as they demonstrate an increase in both the awareness and adoption of GIMOTI. Importantly, these data suggest that as the pandemic abates, our sales force is effectively gaining face-to-face access to our targeted GIs who express an understanding of potential benefits of GIMOTI for their diabetic gastroparesis patients. These results provide meaningful insights for our commercial team in their targeted sales efforts,” commented David Gonyer, R.Ph., Evoke Pharma President and CEO. “These data, in addition to the growing number of new prescribers and the strong refill rates we observed during the first quarter, further solidify our belief in GIMOTI’s ability to answer a critical unmet medical need. We look forward to sharing our findings with other prominent GIs at the upcoming GI ReConnect Conference later this month.”

“There is currently no cure for patients with diabetic gastroparesis. Delayed gastric emptying or vomiting can cause erratic absorption of orally-administered gastroparesis therapies as well as other drugs. GIMOTI is administered nasally and absorbed via the nasal membrane. Since nasal delivery bypasses the GI system, GIMOTI avoids the problem of unpredictable stomach emptying,” stated Beth Gardner, MD, community-based gastroenterologist in Sewell, NJ, “I’ve recently adopted GIMOTI into my treatment regime with some notable initial results. I’ve been switching patients that have failed oral treatment and more recently for a patient that was in and out of the emergency room with frequent vomiting. It’s impossible to know if an oral drug is able to be absorbed in this hard-to-treat patient population.”

“The studies we conducted measured an expanded awareness and adoption of GIMOTI as we continue to build GIMOTI’s presence within the market. I am equally encouraged by the improvement in awareness and intent to prescribe among healthcare practitioners (HCPs) who receive regular visits by our highly motivated sales team as well as those HCPs that are exposed to our innovative online digital campaign,” added Chris Quesenberry, Chief Commercial Officer. “The results of the market research follow the positive reception we received from physicians who express a desire for an alternative to existing oral therapies. They indicate that a nasal route of administration that can bypass the GI tract makes sense for this underserved patient population. We are excited to continue ramping our commercialization efforts and increasing awareness of GIMOTI to ensure that patients and their providers have access to this important therapy.”

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.

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About EVERSANA Life Science Services, LLC

EVERSANA™ is a leading provider of global services to the life science industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product lifecycle 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 science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

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 Contacts:
The Ruth Group
Christine Petraglia / James Salierno
Tel: 917-633-8980 / 973-255-8361
cpetraglia@theruthgroup.com / jsalierno@theruthgroup.com

Media Contact:
The Ruth Group
Annika Parrish
Tel: 720-412-9042
aparrish@theruthgroup.com

Source: Evoke Pharma, Inc.

Source: Evoke Pharma, Inc.