Atossa Genetics Inc. has announced that it has signed manufacturing and quality agreements with AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML) for the manufacturing of a clinical supply for 4-Hydroxytamoxifen, the active pharmaceutical ingredient (API) 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.
Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics, said, "Securing a manufacturing source for the API marks important progress of our clinical program. 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."
"We appreciate this opportunity and look forward to working on Atossa's leading drug candidate. This relationship is an excellent example of our dedication to delivering reliable, flexible and high quality service from our Germantown, WI facility. We look forward to supporting Atossa for its future clinical and commercial success," stated Dr. Stephan Kutzer, CEO, President and Chairman of AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.