Pharmacyclics gets $50 milestone from J&J on ibrutinib progress

California, USA-based Pharmacyclics (Nasdaq: PCYC) says it that enrolment of the fifth patient in the international Phase III randomized, multicenter, open-label clinical trial, RESONATE (PCYC-1112), of ibrutinib versus ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia has triggered a $50 million milestone payment from partner Janssen Pharmaceuticals, part of US health care giant Johnson & Johnson (NYSE: JNJ).

J&J acquired rights to the cancer drug candidate (previously dubbed PCI-32765) last year, in a deal worth a potential $1 billion to Pharmacyclics (The Pharma Letter December 9, 2011). As Pharmacyclics or Janssen initiate further Phase III trials in specific indications and enroll the 5th patient, additional milestone payments of $50 million may be triggered up to a total of $250 million. The company anticipates an additional Phase III trial milestone payment during calendar 2012.

"This is the first Phase III trial of a broad development plan to evaluate the potential of ibrutinib in a range of hematologic malignancies," said Bob Duggan, chairman and chief executive of Pharmacyclics. "We are very excited to have moved this molecule in such short time from first patient dosed in the spring of 2009 to now a pivotal Phase III clinical trial. The initiation of this first Phase III trial with ibrutinib is a testament to the hard work and focused efforts of the entire Pharmacyclics team, our external collaborators and the support and cooperation we enjoy with our partner Janssen. We look forward with confidence to continued progress," he added.