Aradigm tanks on negative FDA advisory panel vote

Following a negative vote from the US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee on Linhaliq (liposomal ciprofloxacin) as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections, shares of the drug’s developer, Aradigm (Nasdaq: ARDM) plunged nearly 34% to $2.26.

The Advisory Committee voted 12 "no" to 3 "yes," with 1 abstention, on the following question: "Has the applicant provided substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa?"

In May 2013, Spanish drugmaker Grifols (GRLS: MC) signed an exclusive, worldwide license for Aradigm's proprietary formulations of inhaled ciprofloxacin (brand names Pulmaquin and Lipoquin) for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines.