Days after announcing that the FDA has accepted its NDA resubmission for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, Evoke Pharma said that the company has cancelled a previously announced commercialization deal with Novus Growth Partners and has signed a new 5-year deal with Eversana for commercialization and distribution of Gimoti in the US if the nasal spray is approved. The PDUFA date for the Gimoti NDA is June 19, 2020.
According to the company, Evoke will retain the NDA for Gimoti and will manufacture the product. Eversana has agreed to provide a $5 million revolving credit facility subject to approval of the NDA and will get “a percentage of product profits in the mid to high teens when Gimoti net sales surpass certain administrative, manufacturing and commercialization costs.”
Evoke President and CEO Dave Gonyer commented, “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. 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.”
Read the Evoke Pharma press release.