Spanish drugmaker Grifols (GRLS: MC) has signed an exclusive, worldwide license for USA-based Aradigm's (OTC BB: ARDM.OB) proprietary formulations of inhaled ciprofloxacin (brand names Pulmaquin and Lipoquin) for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). Aradigm has completed Phase IIb clinical trials in BE patients with Pulmaquin and Lipoquin.
BE is a chronic condition that affects about 110,000 people in the USA and many more in other countries and is characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic respiratory infections. Aradigm has been granted orphan drug designation for BE in the USA and there is currently no drug specifically approved for the treatment of this condition.
Under the terms of the transaction, the companies have agreed to advance Aradigm's proprietary inhaled ciprofloxacin formulations into Phase III clinical trials in BE. Grifols will be responsible for all development and clinical expenses up to a maximum of $65 million for the BE indication. Aradigm is entitled to receive cash payments of up to $25 million on achievement of development milestones.
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