Evoke Pharma, Inc., a specialty pharmaceutical company, has signed an exclusive commercial supply agreement with COSMA S.p.A. for the active pharmaceutical ingredient (API) in its product candidate EVK-001. EVK-001 is the company's novel nasal spray for delivery of metoclopramide for the symptomatic relief of acute and recurrent diabetic gastroparesis in women.
Pursuant to the agreement, COSMA will provide Evoke with the API for EVK-001 that will enable the production of commercial scale quantities in accordance with the FDA standards for chemistry, manufacturing, and controls (CMC). COSMA has been providing metoclopramide to Evoke for several years in association with its clinical trial material supply needs and registration batches, as well as commercial scale production. COSMA has been involved in chemistry and pharmaceuticals broadly for multiple other pharmaceutical firms since 1949. It has an integrated manufacturing facility which is FDA approved, and has the flexibility to widen its production capacity and to harmonize good manufacturing practice (GMP) requirements.
"With this agreement in place, we have finalized another step toward commercial production of EVK-001. COSMA has a wealth of experience providing pharmaceutical companies with quality products, and we have full confidence in their ability to meet the potential needs for the manufacture of EVK-001," Dave Gonyer, R.Ph., Evoke's president and CEO stated. "We continue to be active behind the scenes to ensure that EVK-001 is positioned to get to market as soon as possible, should the drug candidate receive FDA approval. We are excited about the potential market opportunity for our drug candidate and look forward to completing the clinical trial process and providing data early in the third quarter of this year."
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases.