05.08.2015 14:19:18

Atossa Genetics, CML Announce Manufacturing Deal For Atossa's Afimoxifene Gel

(RTTNews) - Atossa Genetics Inc. (ATOS) announced that it has signed manufacturing and quality agreements with AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. or AAI/CML for the manufacturing of a clinical supply for 4-Hydroxytamoxifen, the active pharmaceutical ingredient or 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.

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."

Atossa Genetics said it 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.

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