Ibrutinib: Phase III started

Pharmacyclics enrolled the fifth patient in the open-label, international Phase III RESONATE-2 trial comparing 420 mg oral ibrutinib daily vs. oral chlorambucil given on days 1 and 15 of a 28-day cycle in about 272 treatment-naive patients ages >=65 years. The trial has an SPA from FDA. The enrollment triggered a $50 million milestone payment to Pharmacyclics from Johnson & Johnson's Janssen Biotech Inc. unit under a 2011 deal to co-develop and co-commercialize Pharmacyclics' ibrutinib (see BioCentury, Dec. 12, 2011). The milestone is the fourth under the deal. Pharmacyclics has already received $200 million in milestones and remains eligible for an additional $625 million in development and regulatory milestones (see BioCentury, Aug. 6, 2012 & Oct. 22, 2012). ...