Evoke Pharma, Inc., (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, an independent provider of global commercial services to the life science industry, today announced a collaboration to utilize EVERSANA’s integrated suite of outsourced services to commercialize and distribute Gimoti™ in the United States (U.S.).
Gimoti is Evoke’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. The U.S. Food and Drug Administration (FDA) has set a target goal date under the Prescription Drug User Fee Act (PDUFA) of June 19, 2020. Subject to FDA approval, EVERSANA will fund and commercialize Gimoti and manage substantially all activities related to marketing, market access, distribution, sales team, patient reimbursement, and provide related support services.
“We are excited to partner with EVERSANA, which will allow us to efficiently and rapidly prepare to commercialize Gimoti without the need to invest in a large corporate infrastructure and build out of a sales force. Under the agreement, we will leverage EVERSANA’s integrated suite of capabilities, including highly experienced personnel with proficiency in all key facets of pharmaceutical product commercialization,” commented Dave Gonyer, President and CEO. “We will continue to work with FDA in their review of our NDA while simultaneously coordinating with EVERSANA for a potential product launch this year.”
Jim Lang, CEO of EVERSANA added, “Innovative therapies like Gimoti allow innovative commercialization strategies. That’s why we’ve built a comprehensive integrated commercial services platform, powered by more than 2,000 employees, to bring innovative products to the market, reducing cost and risk while simultaneously improving outcomes. We are very pleased to enter into a strategic partnership with Evoke and look forward to supporting all aspects of commercialization to ensure a smooth and successful launch of Gimoti.”
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Under the terms of the agreement, Evoke maintains ownership of the Gimoti New Drug Application (NDA) as well as all legal, regulatory, and manufacturing responsibilities. Evoke will record sales for Gimoti to EVERSANA’s third party logistics division and retain more than 80% of product profits. EVERSANA will utilize its internal sales organization along with other commercial functions for market access, marketing, distribution and patient support services. EVERSANA will receive reimbursement of certain costs and a percentage of product profits in the mid to high teens when Gimoti net sales surpass certain administrative, manufacturing and commercialization costs. In addition, EVERSANA has agreed to provide up to $5.0 million revolving credit facility to Evoke subject to NDA approval, and certain other conditions. Evoke and EVERSANA retain the right to terminate the agreement upon certain events, including any change of control of Evoke. The term of the agreement is five years following FDA approval, after which Evoke will recapture all product sales and corresponding commercialization responsibilities. Gimoti is under patent protection in the United States until 2030 and upon approval would be the only non-oral out-patient treatment for women suffering from diabetic gastroparesis in the United States.
In addition, Evoke and Novos Growth Partners have mutually agreed to terminate the commercialization agreement dated January 5, 2019.
Source: Biospace
