Evoke Pharma Receives Notices of Allowance for Two Additional US Patent Applications Protecting GIMOTI®
Evoke Pharma (NASDAQ: EVOK) has received notices of allowance for two U.S. patent applications protecting GIMOTI® nasal spray. The patents, titled 'Nasal Formulations of Metoclopramide,' protect the intranasal administration of metoclopramide for treating gastroparesis. These Orange Book listable patents will expire in 2029. GIMOTI is the only FDA-approved, non-oral, patient-administered therapy for acute and recurrent diabetic gastroparesis in the US. The nasal spray bypasses the GI tract, offering an effective solution for patients who struggle with oral medications due to delayed stomach emptying.
Evoke Pharma (NASDAQ: EVOK) ha ricevuto comunicazioni di concessione per due domande di brevetto negli Stati Uniti che proteggono lo spray nasale GIMOTI®. I brevetti, intitolati 'Formulazioni Nasali di Metoclopramide', proteggono l'amministrazione intranasale di metoclopramide per il trattamento della gastroparesi. Questi brevetti, elencabili nell'Orange Book, scadranno nel 2029. GIMOTI è l'unica terapia approvata dalla FDA, non orale e somministrata dal paziente, per la gastroparesi diabetica acuta e ricorrente negli Stati Uniti. Lo spray nasale evita il tratto gastrointestinale, offrendo una soluzione efficace per i pazienti che hanno difficoltà con i farmaci orali a causa del ritardo nello svuotamento dello stomaco.
Evoke Pharma (NASDAQ: EVOK) ha recibido notificaciones de aprobación para dos solicitudes de patente en EE. UU. que protegen el aerosol nasal GIMOTI®. Las patentes, tituladas 'Formulaciones Nasales de Metoclopramida', protegen la administración intranasal de metoclopramida para tratar la gastroparesia. Estas patentes, que se pueden listar en el Orange Book, vencerán en 2029. GIMOTI es la única terapia aprobada por la FDA, no oral y administrada por el paciente, para la gastroparesia diabética aguda y recurrente en EE. UU. El aerosol nasal elude el tracto gastrointestinal, ofreciendo una solución efectiva para los pacientes que luchan con medicamentos orales debido al retraso en el vaciamiento del estómago.
Evok Pharma (NASDAQ: EVOK)는 GIMOTI® 비강 스프레이를 보호하는 두 개의 미국 특허 신청에 대한 허가 통지를 받았습니다. '메토클로프라미드의 비강 제형'이라는 제목의 특허는 메토클로프라미드를 비강으로 투여하여 위마비를 치료하는 것을 보호합니다. 이 오렌지 북에 기재될 수 있는 특허는 2029년에 만료됩니다. GIMOTI는 미국에서 급성 및 재발성 당뇨병성 위마비에 대한 FDA 승인 비경구 자가 투여 치료법입니다. 비강 스프레이는 위장관을 우회하여 위 비움 지연으로 경구 약물 복용에 어려움을 겪는 환자에게 효과적인 솔루션을 제공합니다.
Evoke Pharma (NASDAQ: EVOK) a reçu des notifications d'autorisation pour deux demandes de brevet américaines protégeant le spray nasal GIMOTI®. Les brevets, intitulés 'Formulations Nasales de Métoclopramide', protègent l'administration intranasale de métoclopramide pour le traitement de la gastroparesie. Ces brevets, qui peuvent être listés dans l'Orange Book, expireront en 2029. GIMOTI est la seule thérapie approuvée par la FDA, non orale, administrée par le patient, pour la gastroparesie diabétique aiguë et récurrente aux États-Unis. Le spray nasal contourne le tractus gastro-intestinal, offrant une solution efficace aux patients ayant des difficultés avec les médicaments oraux en raison d'un retard de vidange gastrique.
Evoke Pharma (NASDAQ: EVOK) hat Benachrichtigungen über die Genehmigung für zwei US-Patent-Anträge erhalten, die das Nasenspray GIMOTI® schützen. Die Patente mit dem Titel 'Nasenformulierungen von Metoclopramid' schützen die intranasale Verabreichung von Metoclopramid zur Behandlung von Gastroparese. Diese patenterhaltenden, im Orange Book auflistbaren Patente laufen 2029 aus. GIMOTI ist die einzige von der FDA zugelassene, nicht orale, vom Patienten verabreichte Therapie für akute und wiederkehrende diabetische Gastroparese in den USA. Das Nasenspray umgeht den Magen-Darm-Trakt und bietet eine effektive Lösung für Patienten, die aufgrund einer verzögerten Magenentleerung Schwierigkeiten mit oralen Medikamenten haben.
- Received two new patent allowances strengthening IP protection until 2029
- GIMOTI maintains position as the only FDA-approved metoclopramide nasal spray
- No competing intranasal products currently in development
- None.
Insights
The patent allowances significantly strengthen EVOK's market position and intellectual property protection for GIMOTI through 2029. The two new Orange Book-listable patents specifically protect the intranasal administration method of metoclopramide for gastroparesis treatment. This creates substantial barriers to entry for potential competitors, as GIMOTI remains the only FDA-approved non-oral treatment option in this space.
The patent portfolio's expansion is particularly valuable given GIMOTI's unique market position and the historical regulatory challenges faced by competing therapies. With no competing intranasal products in development and patent protection extending into 2029, EVOK has secured a strong competitive advantage in the gastroparesis treatment market. The intellectual property protection could also make EVOK a more attractive target for potential licensing deals or acquisitions.
SOLANA BEACH, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- 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, today announced that it has received notices of allowance for two U.S. patent applications by the United States Patent and Trademark Office, further expanding the company’s robust intellectual property estate for its innovative GIMOTI® (metoclopramide) nasal spray.
The two patent applications, U.S. 17/366,839 and U.S. 17/366,818, entitled “Nasal Formulations of Metoclopramide,” provide Evoke with additional claims protecting the intranasal administration of metoclopramide for the treatment of gastroparesis. When issued, these patents will bolster the Company’s position as the provider of the only FDA-approved, non-oral, patient administered therapy for acute and recurrent diabetic gastroparesis in the US. The two patents are expected to be Orange Book listable and expire at the end of 2029.
One of the key challenges in treating gastroparesis is ensuring effective drug absorption, as delayed stomach emptying often compromises the efficacy of orally administered medications. GIMOTI bypasses the GI tract, offering patients a reliable and effective treatment option.
“These new patents further solidify GIMOTI’s position as a groundbreaking therapy in the gastroparesis treatment landscape,” said Matt D’Onofrio, CEO of Evoke Pharma. “GIMOTI remains the only FDA-approved metoclopramide nasal spray, offering a novel solution for patients with diabetic gastroparesis who face significant challenges with oral medications. Data from patient support groups show that many patients are unable to find relief with oral therapies. Our most recent real-world head to data show that patients can get relief with Gimoti. With no competing intranasal products in development and a history of regulatory hurdles for other therapies in this space, these patents reinforce GIMOTI’s uniqueness and strengthen our ability to build an important market product. We are proud to continue setting the standard for innovation in gastroparesis treatment.”
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 our FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations. Metoclopramide 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 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, and effects on the ability to drive and operate machinery. Most common adverse reactions (≥
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: 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 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-Boateng
DKB Partners
Tel: 862-213-1398
FAQ
What new patents did Evoke Pharma (EVOK) receive for GIMOTI?
When do Evoke Pharma's (EVOK) new GIMOTI patents expire?
What is unique about GIMOTI compared to other gastroparesis treatments?
