EVOKE PHARMA, INC. With a determined focus to ensure maximum market access for GIMOTI, Evoke is executing its plan to expand net product sales throughout 2024. This update outlines the key areas of Evoke s strategic blueprint and depicts the early successes of its implementation.
ASPN Pharmacy Platform
In
We continue to make inroads into the diabetic gastroparesis market and believe we are best 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 for future demand, said Chris Quesenberry Chief Commercial Officer for GIMOTI.
Medicaid access through Pharmacy Partnerships
As a patient-centric organization,
As of
Halfway into 2024, we are executing on our expansion strategy and are seeing improved growth for the trajectory of GIMOTI s access and sales. The shift to ASPN is yielding results and unveiling GIMOTI s true market potential, stated Matt D Onofrio, CEO of
Leadership Changes and Operational Enhancements
In alignment with our growth objectives, we are pleased to announce the promotion of
Evoke is committed to maintaining a lean business model to maximize value for our stakeholders. Mark s promotion, along with other strategic C-Suite appointments, is a key part of our plan to streamline operations and reduce overhead costs while accelerating growth. By optimizing our leadership team, we are well-positioned to achieve sustainable growth and deliver enhanced value to our investors.
The company will report full results for sales in the second quarter in
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.
About
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
About EVERSANA
EVERSANA is a 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 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world.
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: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke s or EVERSANA s marketing efforts; Evoke s commercialization plans, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants and Evoke s expected 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 not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke s and EVERSANA s ability to successfully drive market demand for GIMOTI; 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
Contact:
Tel: 862-213-1398
Email: dboateng@dkbpartners.net
Email: matt.braun@eversana.com
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