Aradigm enters into collaboration agreement with University of Sydney
Aradigm Corporation announced that it entered into an agreement with the University of Sydney to collaborate on a joint program on the development of advanced nanotechnologies for targeting bacterial and fungal biofilms that are often present with concomitant infections in chronic diseases such as cystic fibrosis and non-CF bronchiectasis. This agreement provides for funding of A$420,000 over a three-year period from the Australian Research Council through the Australian Linkage Project program. Aradigm recently announced the completion of the dosing of patients in the Phase 3 clinical program for Pulmaquin in non-CF BE consisting of two worldwide, double-blind, placebo-controlled pivotal trials that were identical in design except for a pharmacokinetics sub-study that was conducted in one of the trials only. Each trial enrolled patients into a 48-week double-blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants received Pulmaquin. The superiority of Pulmaquin vs. placebo during the double-blind period is being evaluated in terms of the time to first pulmonary exacerbation, while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator. Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. FDA has designated Pulmaquin as a Qualified Infectious Disease Product. The QIDP designation is granted for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014. In 2013, Aradigm granted an exclusive, world-wide license for the Company's inhaled liposomal ciprofloxacin product candidates for the indication of non-CF BE and other indications to Grifols S.A.