Acasti Pharma Signs Manufacturing Agreement
"Acasti's manufacturing processing steps will be followed using current Good Manufacturing Practices (cGMP) guidelines, utilizing scrutinized process directives under our direct supervision," said Dr. Harlan W. Waksal, Executive Vice President, Business and Scientific Affairs at Acasti. Specialized krill oil raw material will first be produced by a North American company using Neptune's proprietary production process. It will then be sent to the specialty chemicals manufacturer for further processing, including purification and formulation into CaPre under cGMP guidelines.
"These agreements will ensure sufficient quantities of CaPre for expected PK and Phase III clinical trials," added Dr. Waksal. "They will also play a crucial role in the preparation of the Chemistry, Manufacturing and Control (CMC) section of Acasti's IND submission to conduct the clinical trials in the USA. This marks a major milestone and an important step in driving further value creation." Acasti intends to initiate discussions to manufacture CaPre at full plant scale, should regulatory approval for commercialization in the USA be obtained. Names of potential partners are not disclosed for confidentiality and strategic reasons.
Acasti is currently conducting Phase II clinical trials of CaPre, with the final report for the open-label, dose ranging study (COLT) expected for this summer and completion of the double blind, placebo controlled study (TRIFECTA) projected for the first half of calendar 2014. Concurrently with these trials, the corporation is moving forward with its plan to submit an IND filing with the U.S. Food and Drug Administration (FDA) to initiate PK and phase III clinical trials of CaPre in the USA.