Evoke Pharma Stock

Evoke Pharma, Inc., a specialty pharmaceutical company, focuses primarily on the development and commercialization of drugs to treat gastrointestinal (GI) disorders and diseases.

The company is developing its sole product, Gimoti (metoclopramide) nasal spray, the nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. In 2020, the company received approval from the U.S. Food and Drug Administration, or FDA, for its 505(b)(2) New Drug Application, or NDA, for Gimoti. The company launched commercial sales of Gimoti in the United States in 2020 through its commercial partner Eversana.

The company is party to a commercial services agreement with Eversana Life Science Services, LLC (Eversana), or the Eversana Agreement. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in the United States. Eversana also manages the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti within the United States. The company launched commercial sales of Gimoti in 2020 with Eversana.

Business Strategy

The company’s business strategy is to successfully commercialize Gimoti in the United States; further development of Gimoti with a lower dosage strength to expand its market potential; seek partnerships to accelerate and maximize the potential for Gimoti; and in-license or acquire additional clinical or commercial stage product candidates for the treatment of GI diseases in a capital efficient manner.

Gimoti (Metoclopramide) Nasal Spray

The company developed Gimoti, a dopamine antagonist / mixed 5-HT3 antagonist / 5-HT4 agonist with promotility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Gimoti is a novel formulation of metoclopramide offering systemic delivery by nasal spray administration.

The company developed the nasal formulation of metoclopramide to provide its targeted patient population with acute or recurrent symptoms of diabetic gastroparesis with a product that can be systemically delivered as an alternative to the oral or intravenous routes of administration.

Future Clinical Trials

The company is evaluating the design of a single dose pharmacokinetics, or PK, clinical trial of Gimoti, based on an FDA post-marketing commitment. This trial will be designed to characterize dose proportionality of a lower dosage strength of Gimoti to accommodate patients that may require further dosage adjustments, with initiation timing pending additional feedback from the FDA.

Commercialization

The company is commercializing Gimoti in the United States through its partnership with Eversana. The company’s strategy is to establish Gimoti as the prescription product of choice for diabetic gastroparesis. Gimoti is initially being marketed to gastroenterologists, internal medicine specialists, primary care physicians and select health care providers. The company has engaged Eversana to utilize its internal sales organization, along with additional commercial functions, for market access, marketing, distribution, and other related patient support services.

Commercial Services Agreement with Eversana

On January 21, 2020, the company entered into the Eversana Agreement for the commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in the United States. Eversana also manages the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti in the United States.

Under the terms of the Eversana Agreement, the company maintains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for Gimoti. Eversana will utilize its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services.

On February 1, 2022, the Eversana Agreement was amended to extend the term from June 19, 2025 (five years from the date the FDA approved the Gimoti NDA) to December 31, 2026, unless terminated earlier pursuant to its terms.

Gimoti Product Launch

The U.S. launch of Gimoti occurred in October 2020 through the company’s commercial partner Eversana and its specialty pharmacy services. In February 2022, Eversana began to transition these services to vitaCare Prescription Services, or vitaCare, a technology and services platform that helps physicians electronically prescribe Gimoti and helps patients navigate key access and adherence barriers for brand medications, and Thrifty White, a leading specialty pharmacy. Starting in July 2022, vitaCare was the sole prescription intake system used for Gimoti.

As of December 31, 2022, Eversana had 27 Gimoti dedicated sales representatives located throughout the U.S. In addition to the field sales team, Eversana telemarketing representatives field inbound calls and contact targeted physicians outside of the currently covered geographies. Gimoti is also being promoted through social media and digital promotion through patient support groups and other online resources.

Manufacturing

In November 2017, the company entered into a Manufacturing Services Agreement with Patheon UK Limited, or Patheon, a wholly-owned subsidiary of Thermo Fisher, Inc., pursuant to which Patheon has agreed to manufacture commercial quantities of Gimoti. Under the terms of the agreement, the company is required to purchase a certain percentage of its requirements for its Gimoti product intended for commercial sale, provided certain terms and conditions are met. The initial term of the agreement commenced in November 2017 and will continue in effect until December 31, 2025.

In May 2016, the company entered into a Master Supply Agreement with Cosma S.p.A., or Cosma, pursuant to which Cosma will be the exclusive commercial supplier of metoclopramide for the manufacture of Gimoti. Under the supply agreement, Cosma will supply metoclopramide pursuant to purchase orders which the company may deliver to Cosma from time to time, and there is no minimum supply requirement.

Intellectual Property and Proprietary Rights

Patent Portfolio

The company’s patent portfolio consists of patents and patent applications, including the following U.S. patents and patent applications as of December 31, 2022:

U.S. Patents 8,334,281 and 11,020,361 —Nasal Formulations of Metoclopramide. These patents are expected to expire no earlier than December 22, 2029, and have four pending Continuation applications (U.S. Non-Provisional Patent Application No. 17/100,664 (allowed by USPTO November 28, 2022); 17/366,818; 17/366,829; and 17/366,839).

U.S. Non-Provisional Patent Application No. 17/381,464 – Treatment of Symptoms Associated with Female Gastroparesis. If granted, this patent is not expected to expire earlier than 2032.

U.S. Patent 11,517,545 – Treatment of Moderate and Severe Gastroparesis. This patent is expected to expire no earlier than 2038 and have one pending Continuation application (U.S. Non-Provisional Patent Application No. 18/047,364).

U.S. Non-Provisional Patent Application No. 16/646,527 – Methods of Intranasal Metoclopramide Dosing. If granted, this patent is not expected to expire earlier than 2038.

The company has also been granted European and Canadian patents for pharmaceutical compositions comprising metoclopramide. These patents are expected to expire no earlier than 2029. The company has also been granted European, Japanese, Russian and Mexican patents for the use of intranasal metoclopramide for treating diabetic gastroparesis in human females. These patents are expected to expire no earlier than 2032. Additional patent applications have been filed in the United States and abroad related to more recent clinical trial findings.

Other Intellectual Property Rights

The company has a registered trademark for EVOKE PHARMA and other trademarks, including GIMOTI in the United States.

Government Regulation

The company and its third-party manufacturers must comply with applicable FDA regulations relating to current good manufacturing practices (cGMP), including applicable QSR (Quality System Regulation) requirements for the device component of Gimoti. The manufacturing facilities for the company’s products must meet cGMP requirements to the satisfaction of FDA pursuant to a pre-approval inspection before it can use them to manufacture the company’s products. The company and its third-party manufacturers are also subject to periodic unannounced inspections of facilities by FDA and other authorities, including procedures and operations used in the testing and manufacture of the company’s products to assess its compliance with applicable regulations.

History

Evoke Pharma, Inc. was founded as a Delaware corporation in 2007. The company was incorporated in 2007.