Date: 2013-09-16
Type of information: Production agreement
Compound: Pulmaquin® (inhaled ciprofloxacin)
Company: Sigma-Tau PharmaSource, subsidiary of Sigma-Tau Pharmaceuticals (USA - Italy) Aradigm Corporation (USA)
Therapeutic area: Respiratory diseases - Rare diseases - Genetic diseases
Type agreement:
Action mechanism:
Disease: severe respiratory diseases, including non-cystic fibrosis bronchiectasis
Details: * On September 16, 2013, Sigma-Tau PharmaSource, a wholly owned subsidiary of Sigma-Tau Pharmaceuticals and Aradigm Corporation, an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases, announced that they have entered into a broad manufacturing services agreement whereby Sigma-Tau PharmaSource will provide Aradigm with clinical and commercial supplies of Pulmaquin®. Pulmaquin is Aradigm’s proprietary formulation of inhaled ciprofloxacin for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). Under terms of the agreement, Sigma-Tau PharmaSource will manufacture all product for Aradigm’s Phase 3 clinical studies, and will support Aradigm in the preparation of its submissions to regulatory authorities in pursuit of marketing approval for the product. Subsequent to market approval, Sigma-Tau PharmaSource will produce the product commercially for patients using Pulmaquin®.
Financial terms: Financial terms of the agreement were not disclosed.
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