Evoke Pharma Signs Commercial and Financial Agreement for its Lead Product Gimoti™ in the U.S. with Novos Growth Partners
January 07, 2019 at 07:00 pm IST
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Evoke Pharma, Inc. announced a partnership with Novos Growth Partners (NGP) to commercialize Gimoti™, the company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. NGP will manage the commercial operations for a dedicated sales team to market Gimoti to gastroenterologists and other targeted health care providers, if approved. NGP will also provide non-dilutive working capital for commercialization costs prior to and following product launch. The U.S. Food and Drug Administration (FDA) has set a target goal date under the Pharmaceutical Drug User Fee Act (PDUFA) of April 1, 2019. Under the terms of the agreement, Evoke maintains ownership of the Gimoti New Drug Application (NDA). In addition, Evoke will maintain legal, regulatory, and manufacturing responsibilities. Evoke will also retain a contract sales organization, which would be managed by NGP and who will finance the working capital for launch. Evoke will record sales for Gimoti and retain more than 80% of product profits. NGP will receive a percentage of product profits in the mid to high teens as a service fee once Gimoti net sales surpass commercialization costs. In addition to the non-dilutive working capital, NGP has agreed to provide up to $5.0 million to Evoke in a line of credit following NDA approval. Evoke and NGP 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, after which Evoke will recapture 100% of product sales and corresponding responsibilities.
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.