Aradigm has received a $5 million milestone payment from Grifols as the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial of Pulmaquin inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis gets underway, the company announced. In May 2013, Grifols paid $25 million upfront to license Aradigm’s inhaled ciprofloxacin formulations, with the potential for an additional $25 million in milestone payments.
The ORBIT-3 study will evaluate Pulmaquin versus placebo during a 48-week double-blind period followed by a 28-day open-label period using time to first exacerbation as the primary endpoint. Another, almost identical, study will be called ORBIT-4. Both studies are planned to enroll about 255 patients; one will include a PK sub-study.
Aradigm CFO Nancy Pecota said, “I am pleased that our team has achieved this very important milestone, which also further strengthens our financial position.”
Read the Aradigm press release.
