Inhaled liposomal ciprofloxacin developer Aradigm Corporation announced that it has filed for bankruptcy under Chapter 11 of the US Bankruptcy Code and plans to sell all of its assets.
The company said that “Aradigm remains confident in the efficacy, safety and quality of Apulmiq (US)/Linhaliq (EMA). We are committed to continue working toward the approval of Apulmiq (US)/Linhaliq (EMA) for non-cystic fibrosis bronchiectasis (NCFBE) patients who have chronic infection with P. aeruginosa, resulting in severe disease with frequent exacerbations, high morbidity and mortality, and no available treatment options.”
In January 2018, Aradigm received a CRL in response to its NDA for Apulmiq (then Linhaliq) dual release ciprofloxacin for the treatment of P. aeruginosa infections in NCFBE patients. In the EU, Aradigm filed an MAA for Linhaliq for the same indication in March 2018, and the company recently announced that it had submitted responses to EMA Day 120 questions.
According to Aradigm, the company determined on February 11, 2019 “that without confirmation of funding from their primary investor and partner,” it could not pay its bills going forward. Grifols acquired an exclusive license to Aradigm’s inhaled ciprofloxacin formulations in 2013. The company will now sell its assets “to an interested party, subject to Bankruptcy Court approval.”
Read the Aradigm Corporation press release.
