Send to printer »

GEN News Highlights : Sep 16, 2013

Sigma-Tau PharmaSource, Aradigm Ink Manufacturing Deal for Respiratory Disease Treatment

Sigma-Tau PharmaSource and Aradigm have entered into a broad manufacturing services agreement in which Sigma-Tau PharmaSource will provide Aradigm with clinical and commercial supplies of Pulmaquin®, Aradigm’s formulation of inhaled ciprofloxacin for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis.

Per the agreement, Sigma-Tau PharmaSource will manufacture all product for Aradigm’s Phase III clinical studies and will support the company in the preparation of its submissions to regulatory authorities. Subsequent to market approval, Sigma-Tau PharmaSource will produce the product commercially for patients using Pulmaquin.

According to Aradigm, the firms have previously worked together on multiple programs, including the manufacturing of Aradigm’s AERx® inhaler dosage forms and all Phase I and Phase II clinical supplies of Aradigm’s inhaled ciprofloxacin formulations.