Evoke Pharma announced that an amendment of its agreement with Mallinckrodt allows for deferral of milestone payments due on acceptance of review of the company’s NDA for Gimoti intranasal metoclopramide for the treatment of gastroparesis in women and on final approval. The agreement now allows for a single milestone payment that will be due a year after FDA approval of the NDA.
The intranasal metoclopramide formulation was originally developed by Questcor, which was acquired by Mallinckrodt in 2014. Evoke acquired rights to the drug in 2007.
In late 2017, Evoke announced that it had signed a 5-year agreement with Patheon for commercial manufacturing of Gimoti after announcing plans for submission of a 505 (b)(2) NDA in early 2018.
Evoke President and CEO Dave Gonyer commented, “We continue to focus our current resources on the NDA submission and commercial preparation of Gimoti and appreciate Mallinckrodt’s support of Evoke and our intent to bring Gimoti to market. This deferral provides us additional available capital. We have now improved our cash runway to January of next year and remain on track to submit the Gimoti NDA next quarter.”
Read the Evoke Pharma press release.
