Evoke Pharma said that it has signed a deal with Novos Growth Partners (NGP) for commercialization of its Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women. Evoke’s NDA for Gimoti was submitted in June 2018, and the FDA set a PDUFA date of April 1, 2019 for completion of its review.
According to Evoke, if Gimoti is approved, a US launch is expected in 2019, and NGP will supply funding for commercialization as well as managing sales efforts to market Gimoti to health care providers, primarily gastroenterologists. Ownership of the NDA would remain with Evoke, and the company would continue to be responsible for regulatory and manufacturing activities.
Evoke Pharma President and CEO Dave Gonyer said, “This is a landmark agreement for Evoke and leverages NGP’s fully integrated commercialization platform and experienced management team for the commercialization of Gimoti. The combination of NGP’s commercial capabilities and financial resources address several of our corporate interests while allowing us to retain product ownership, a significant percentage of sales revenue and additional strategic flexibilities. We are working closely with NGP in preparation for Gimoti’s potential product launch this year.”
Read the Evoke Pharma press release.