Thermo Fisher Scientific’s Patheon Division to Manufacture Nasal Formulation for Evoke Pharma

Patheon will be the commercial manufacturer for the gastroparesis treatment Gimoti.

Patients with gastroparesis (also known as gastric stasis) have stomach muscles that do not behave properly, moving food from the stomach into the intestine too slowly, out of rhythm or erratically. Contraction and relaxation of the stomach muscles cause the physical breakdown of food in the stomach that has been mixed the acidic gastric juices into a liquefied form referred to as chyme. Properly functioning stomach muscles push this material through the pyloric canal into the small intestine in a controlled and regulated manner.

When these muscles do not function correctly, the result can be nausea, early satiety, prolonged fullness, bloating, upper abdominal pain, vomiting and retching, leading patients to limit food intake and thus suffer from malnutrition, dehydration and electrolyte disturbances. Ultimately, these issues lead to serious, chronic medical problems. Currently, the main treatment is metoclopramide, which is available as a traditional tablet, an oral disintegrating table and intravenously. Several other drugs are used off-label, but there is a need for alternative medications that are more effective.

Evoke Pharma, which specializes in the development of treatments for gastrointestinal diseases, has as its lead candidate Gimotiä, a novel formulation of metoclopramide offering systemic delivery by intranasal administration for women with diabetes mellitus that are suffering from acute and recurrent diabetic gastroparesis. Intranasal administration is advantageous compared to oral delivery due to the nature of the disease and may be an alternative to intravenous delivery as well, according to Evoke.

The company has conducted a number of clinical trials, including a Phase 1 pharmacokinetic bioavailability study, a Phase 1 thorough ECG cardiac safety trial, a Phase 2b efficacy and safety trial, a Phase 3 efficacy and safety trial in women and a companion efficacy and safety trial in men. In October 2017, Evoke announced positive topline results from a comparative exposure PK study. Based on the results of the study, the company plans to submit a 05(b)(2) New Drug Application (NDA) with a selected Gimotiä dose to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.

"We are very pleased this study has met our objective of demonstrating bioequivalence on the measure of AUC to identify a Gimoti dose," said Dave Gonyer, Evoke Pharma's CEO. Mr. Gonyer continued, "In the first quarter of 2018, we will submit the NDA with these PK data, as well as safety and efficacy data from five prior Evoke clinical studies in healthy volunteers and patients with diabetic gastroparesis. We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease and we look forward to providing further updates regarding the NDA as we move quickly toward submission."

More recently, Evoke announced that it has selected the Patheon division of Thermo Fisher Scientific as the commercial manufacturing partner for Gimoti™. Patheon, leading global contract development and manufacturing organization (CDMO) with specialized capabilities for the preparation, fill and finish of nasal spray products, was recently acquired by Thermo Fisher.

"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," stated Gonyer. "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."


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