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Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient in Frontline Phase III CLL Study
Date:4/11/2013

SUNNYVALE, Calif., April 11, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the Phase III clinical trial (RESONATE™-2), a monotherapy trial using ibrutinib versus chlorambucil in elderly patients with newly diagnosed chronic lymphocytic leukemia / small lymphocyctic lymphoma (CLL/SLL) has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a fourth $50 million milestone payment obligation from Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, worldwide collaborator on ibrutinib in oncology.

This trial is a randomized, multicenter, open-label Phase III study of ibrutinib (PCI-32765) as a monotherapy versus chlorambucil in patients 65 years or older with treatment-naïve CLL/SLL. The study design is in accord with a Special Protocol Assessment (SPA). The study is designed to demonstrate superiority of ibrutinib with the primary endpoint of progression-free survival (PFS); the comparator is single agent chlorambucil. This global study is planned to enroll 272 patients worldwide.

Further information about this trial can be found at www.clinicaltrials.gov:
NCT01722487 – "A Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (RESONATE™-2)."

About the Janssen Collaboration
As previously announced on December 8, 2011, Pharmacyclics entered into a worldwide collaboration with Janssen to develop and commercialize ibrutinib, a novel, oral, first-in-class Bruton's Tyrosine Kinase (BTK) inhibitor. Pharmacyclics received from Janssen an upfront payment totaling $150 million upon signing the contr
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SOURCE Pharmacyclics, Inc.
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