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About Evoke Pharma Inc.
Evoke Pharma Inc. (NASDAQ: EVOK), headquartered in Solana Beach, California, is a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for gastrointestinal (GI) disorders and diseases. With a primary focus on diabetic gastroparesis, Evoke addresses a critical unmet medical need by offering a novel, non-oral treatment option that improves patient outcomes and enhances quality of life.
Core Product: Gimoti
At the heart of Evoke Pharma's portfolio is Gimoti®, an FDA-approved nasal spray formulation of metoclopramide. Designed specifically for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults, Gimoti offers a unique solution for patients who struggle with oral medications due to delayed gastric emptying, a hallmark of gastroparesis. By bypassing the gastrointestinal tract, Gimoti ensures reliable drug absorption, addressing the core defect of the disease and providing a practical alternative to traditional oral and injectable formulations.
Market Position and Competitive Landscape
Diabetic gastroparesis is a debilitating condition affecting millions worldwide, with a disproportionate prevalence among women. Despite its widespread impact, treatment options remain limited. Metoclopramide is the only FDA-approved drug for gastroparesis in the United States, and Gimoti stands out as the sole non-oral formulation available. This positions Evoke Pharma as a key player in the GI treatment landscape, offering a differentiated product that meets the needs of a historically underserved patient population.
Innovative Approach and Strategic Partnerships
Evoke Pharma's commitment to innovation is evident in its development of Gimoti, which leverages intranasal drug delivery to overcome the challenges associated with oral medications in gastroparesis patients. The company has also established strategic partnerships, such as its collaboration with EVERSANA, to support the commercialization and market access of Gimoti. These partnerships enhance Evoke's ability to reach patients, streamline the prescription process, and ensure broad access to its groundbreaking therapy.
Real-World Evidence and Impact
Real-world data underscores the clinical and economic benefits of Gimoti. Studies have demonstrated significant reductions in emergency room visits and hospitalizations among patients treated with Gimoti compared to oral metoclopramide. Additionally, Gimoti has shown a substantial reduction in overall healthcare costs, highlighting its value to both patients and payers. These outcomes reinforce Evoke Pharma's role in improving patient care and reducing the burden on the healthcare system.
Commitment to Patients and Providers
Evoke Pharma is dedicated to addressing the challenges faced by gastroparesis patients and their healthcare providers. The company's patient assistance programs and efforts to expand pharmacy distribution networks reflect its mission to ensure that no patient goes untreated due to economic or access barriers. By prioritizing patient-centric solutions and leveraging strong clinical evidence, Evoke continues to set the standard for innovation in gastroparesis treatment.
Evoke Pharma, Inc. (Nasdaq: EVOK), focused on GI treatments, will release its Q2 2021 financial results on August 12, 2021, post-market. A conference call will follow at 4:30 p.m. ET to discuss the results, with dial-in numbers provided for domestic and international participants. The company is known for GIMOTI®, a nasal spray for diabetic gastroparesis, the only FDA-approved treatment in the U.S. for this condition. Evoke cautions that forward-looking statements may not guarantee future results due to various risks, including reliance on GIMOTI and potential disruptions from COVID-19.
Evoke Pharma (NASDAQ: EVOK) and EVERSANA have announced their support for Gastroparesis Awareness Month through sponsorship of the upcoming Digestive Health Virtual Walk by the International Foundation for Gastrointestinal Disorders. This collaborative effort aims to raise awareness about gastroparesis and promote community education regarding its diagnosis and management. The virtual walk runs from August 21 to September 4, 2021, allowing participants to engage at their own pace. Evoke has also established the EvokeAssist program to aid patients affected by diabetic gastroparesis.
Evoke Pharma, focusing on gastrointestinal diseases, announced marketing initiatives for GIMOTI, its nasal spray for diabetic gastroparesis (DGP). The program aims to increase awareness and trial among healthcare providers by providing samples primarily to gastroenterologists and advanced practice practitioners. A recent study indicated that 20-40% of DGP patients struggle with oral medication absorption, leading to significant interest from physicians in prescribing GIMOTI. Evoke hopes this initiative will enhance access to its treatment for those with DGP.
Evoke Pharma has announced its membership in the International Foundation for Gastrointestinal Disorders (IFFGD) Industry Council, aiming to enhance support for patients with diabetic gastroparesis. This membership allows Evoke to participate in biannual meetings focused on industry insights. Additionally, Evoke will sponsor the IFFGD’s 30th Anniversary Digestive Health Virtual Walk in August 2021, aiming for participants to collectively walk 10,950 miles as part of Gastroparesis Awareness Month. This initiative highlights the significant unmet medical need for new treatments in this area.
Evoke Pharma (NASDAQ: EVOK) reports positive findings from a recent market research study on GIMOTI (metoclopramide) nasal spray. Conducted by EVERSANA, the study reveals an 81% intent to prescribe GIMOTI, up from previous figures, including 90% among targeted gastroenterologists. Awareness of GIMOTI has also risen significantly, with 46% of targeted GIs reporting high awareness. The data suggests that GIMOTI is increasingly recognized as an effective treatment for diabetic gastroparesis. Evoke anticipates further discussion on these findings at the upcoming GI ReConnect Conference.
Evoke Pharma announced that its patent No. 11,020,361 for Gimoti (metoclopramide) nasal spray is now listed in the FDA's Orange Book, enhancing intellectual property protection. Gimoti is FDA-approved for treating symptoms of acute and recurrent diabetic gastroparesis and is the first non-oral option available for this condition. The new patent extends protection until at least 2029. President David Gonyer expressed confidence in Gimoti's potential to improve patient quality of life by offering a unique treatment method.
Evoke Pharma announced the issuance of US patent No. 11,020,361 for its Gimoti nasal spray, enhancing intellectual property protection for treating diabetic gastroparesis. This patent, valid until at least 2029, is expected to be listed in the FDA’s Orange Book. Gimoti is the first outpatient non-oral treatment for gastroparesis, approved by the FDA in June 2020, targeting symptoms related to gastric emptying delays. The company aims to position Gimoti as the preferred treatment choice in the gastroparesis market.
Evoke Pharma has launched an innovative social media campaign aimed at educating and supporting patients with diabetic gastroparesis (DGP). This campaign, in partnership with EVERSANA, utilizes Facebook to create dedicated pages for GIMOTI, a nasal spray treatment, and a community page called DGP-n-Me. The initiative addresses a significant gap in patient education and community support, catering to an estimated 16 million DGP patients in the U.S. GIMOTI is the first FDA-approved nasal delivery treatment for this condition, offering an alternative when oral therapies fail.
Evoke Pharma (NASDAQ: EVOK) announced the appointment of Vickie Reed to its board of directors, succeeding Ann Rhoads, who is retiring after over eight years. Vickie Reed brings extensive experience in finance and strategic leadership within the biotechnology sector, having previously raised over $2 billion in financing at Mirati Therapeutics. Evoke Pharma focuses on developing treatments for gastrointestinal disorders, notably its FDA-approved drug GIMOTI, a nasal spray for diabetic gastroparesis.
Evoke Pharma reported significant growth in Q1 2021 with 293% rise in product sales and a 235% increase in prescriptions for Gimoti. The company expanded its prescriber base by 87%, aiming to enhance sales through targeted marketing strategies. Despite a net loss of $2.6 million for the quarter, up from $1.8 million, Evoke's cash reserves stand at $18.2 million, supporting operations into Q1 2022.
Additionally, a notice of allowance from the USPTO is expected to bolster Gimoti's patent protections.
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