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Evoke Pharma selects Patheon for manufacture of Gimoti intranasal metoclopramide

Evoke Pharma has announced that has signed a 5-year agreement with CDMO Patheon for commercial manufacturing of Evoke’s Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis. Patheon was acquired by Thermo Fisher earlier this year.

In October 2017, Evoke announced that it plans to submit a 505(b)(2) NDA for Gimoti early in 2018 based on positive results from a PK bioequivalence study.

Evoke President and CEO Dave Gonyer said, “We are very pleased to announce the selection of Thermo Fisher as our commercial manufacturing partner, which will supply Gimoti in accordance with FDA standards for chemistry, manufacturing and controls (CMC) as we move closer toward a potential approval of Gimoti. We believe that Thermo Fisher’s recent acquisition of Patheon, a CDMO who we have worked closely with since 2008, provides additional expertise in the manufacturing of nasal spray products and makes them an ideal partner. The partnership is another critical step for the company as we continue to move closer to the commercialization of Gimoti and we are working diligently to prepare and finalize our NDA submission by next quarter.”

Read the Evoke Pharma press release.

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published on November 13, 2017

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