Sep 16 2013
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.
This article was reprinted from Genetic Engineering & Biotechnology News (GEN) with permission from Mary Ann Liebert, Inc., publishers. Genetic Engineering & Biotechnology News (GEN) has retained its position as the number one biotech publisher around the globe since its launch in 1981. GEN publishes a print edition 21 times a year and has additional exclusive editorial content online, like news and analysis as well as blogs, podcasts, webinars, polls, videos, and application notes. GEN's unique news and technology focus includes the entire bioproduct life cycle from early-stage R&D, to applied research including omics, biomarkers, as well as diagnostics, to bioprocessing and commercialization.