In June, the US Food and Drug Administration (FDA) is set to decide whether to approve Evoke’s nasal spray treatment for use in in adult women with acute and recurrent diabetic gastroparesis. Ahead of the FDA’s decision, Evoke has struck a deal to support the commercialization of the drug, Gimoti (metoclopramide), in the US.
The deal makes Eversana responsible for funding and commercializing Gimoti. Eversana will manage “substantially all” tasks involved in marketing, market access, distribution, sales and reimbursement.
In carrying out the tasks, Eversana will leverage its internal sales organization and other commercial capabilities. Water Street and JLL Partners established those capabilities by rolling up six previously independent service providers, including Dohmen Life Science Services and The Access Group.
Evoke remains in charge of the new drug application (NDA), which the FDA accepted last month, as well as all legal, regulatory and manufacturing work related to Gimoti.
The financial terms of the deal will see Evoke reimburse Eversana for certain costs and give it a cut of the profits from Gimoti. Evoke expects to retain more than 80% of the profits from the drug, putting Eversana’s cut in the mid to high teens. Eversana is set to provide Evoke with a $5m (€4.5m) revolving credit facility.
That arrangement will stay in place for the five years following potential approval by the FDA. Beyond that, Evoke will take full responsibility for commercialization and keep all of the profits.
The terms of the Eversana deal echo those of a previous agreement Evoke entered into with Novos Growth Partners. Through the Novos deal, Evoke received comparable services to those now being provided by Eversana in exchange for a similar royalty rate. The Novos agreement also featured a $5m line of credit.
However, Evoke and Novos “mutually agreed to terminate” their commercialization agreement. In between the deal being signed in January 2019 and scrapped a year later, Evoke tried unsuccessfully to bring Gimoti to market.
The US FDA rejected Gimoti due to issues related to clinical pharmacology and product quality. In the refiled application, Evoke has tried to address those issues through the inclusion of the findings of an in-depth root cause analysis and three-month stability data from registration batches manufactured at commercial scale.