Pharmacyclics, Inc. (PCYC)

[surf1944]

6:31AM Pharmacyclics triggers milestone payment and provides clinical program update (PCYC) 53.21 : Co announced that 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 or small lymphocytic lymphoma (CLL/SLL) initiated by Pharmacyclics has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a $50 mln milestone payment obligation from Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) and the worldwide collaborator on ibrutinib in oncology. As Pharmacyclics or Janssen initiate further Phase III trials in specific indications and enroll the 5th patient, additional milestone payments of $50 mln may be triggered up to a total of $250 mln. Co anticipates an additional Phase III trial milestone payment during calendar 2013. Pharmacyclics and Janssen plan to initiate three additional Phase III studies over the next 6 - 9 months. These studies include Phase III combination study of bendamustine/rituximab plus ibrutinib versus bendamustine/rituximab plus placebo in relapsed or refractory CLL/SLL patients, Phase III frontline study of single agent ibrutinib versus a comparator in elderly CLL/SLL patients, and a Phase III study outside the US of ibrutinib versus temsirolimus in subjects with relapsed or refractory mantle cell lymphoma (MCL) who have received at least one prior chemotherapy regimen