Biopharmaceutical contract manufacturer Sigma-Tau PharmaSource has entered into a manufacturing services agreement with Aradigm, a specialty pharmaceutical firm focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases.
Under the deal, Sigma-Tau PharmaSource will provide Aradigm with clinical and commercial supplies of Pulmaquin, which is Aradigm's formulation of inhaled ciprofloxacin for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE).
Sigma-Tau PharmaSource specializes in manufacturing complex injectable formulations, including liposomal drug delivery technology and PEGylation.
The deal will see Sigma-Tau manufacture all product for Aradigm's Phase III clinical studies as well as support them in the preparation of its submissions to regulatory authorities in pursuit of marketing approval for the product.
If approved, Sigma-Tau will produce the product commercially for patients using Pulmaquin.
Aradigm president and CEO Igor Gonda said, "Sigma-Tau PharmaSource and Aradigm have a long history of working together on multiple programs, including manufacture of our AERx inhaler dosage forms and, importantly, all of our Phase 1 and Phase 2 clinical supplies of our inhaled ciprofloxacin formulations."
Bronchiectasis, which is a chronic orphan condition characterized by abnormal dilatation of the bronchi and bronchioles related with chronic lung infection, is observed in patients with cystic fibrosis (CF).