Atossa Genetics Inc. has signed manufacturing and quality agreements with AAIPharma Services Corp./Cambridge Major Laboratories Inc. for the manufacturing of a clinical supply for 4-Hydroxytamoxifen, the active pharmaceutical ingredient in Atossa’s leading drug candidate, Afimoxifene gel. In May 2015 Atossa acquired from Besins Healthcare the exclusive rights to Afimoxifene gel for the potential treatment of hyperplasia of the breast.
“Securing a manufacturing source for the API marks important progress of our clinical program,” said Steven Quay, chairman, chief executive officer and president, Atossa Genetics. “With the manufacturing and quality agreements in place, AAI/CML will now begin its work to manufacture a clinical supply of the API. We expect that the initial production of the API will be completed by the end of 2015 and once combined with the proprietary gel to form the clinical drug product we can then begin clinical studies in 2016.”
