The contract development and manufacturing organisation (CDMO) has signed a five-year agreement to commercially manufacturer the Gimoti nasal spray on behalf of Evoke Pharma.
Gimoti – previously known as EVK-001 – is a nasal delivery formulation of metoclopramide intended for the relief of symptoms associated with acute and recurrent diabetic gastroparesis
The partnership with Patheon was announced as “another critical step” in Gimoti’s development by Evoke’s CEO Dave Gonyer, coming 16 months after the candidate failed to achieve its primary endpoint in a Phase III placebo-controlled study.
But earlier this year, Evoke reported a “positive” pre-submission meeting with the US Food and Drug Administration (FDA) and in this latest news Gonyer has confirmed his firm is preparing and finalising a New Drug Application (NDA) submission with the Agency within the first quarter next year.
Patheon was acquired by life sciences firm Thermo Fisher Scientific in August for $7.2bn, and Gonyer said this was an influencing factor on his choice of CDMO.
“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.”
In May, Evoke contracted regulatory consulting third-party Rho to prepare and submit the NDA itself.