Evoke Pharma Enters Commercialization Agreement with EVERSANA Life Sciences for Gimoti™
January 23, 2020 at 08:30 am
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Evoke Pharma, Inc. and EVERSANA™ 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. 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.
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development and commercialization of drugs to treat gastrointestinal (GI) disorders and diseases. The Company operates through the development and commercialization of pharmaceutical products. It is developing its product, Gimoti (metoclopramide) nasal spray, the first and only nasally administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. It developed Gimoti, a dopamine antagonist / mixed 5-HT3 antagonist / 5-HT4 agonist with pro-motility 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. It has developed the nasal formulation of metoclopramide to provide its targeted patient population with acute or recurrent symptoms of diabetic gastroparesis.