Pharmacyclics, Inc. (PCYC) Reaches SPARK Milestone

Pharmacyclics, Inc. (Nasdaq: PCYC) announced today that the clinical trial, SPARK (MCL2001), of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a second $50 million milestone payment obligation from Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, worldwide collaborator on ibrutinib in oncology and sponsor of this MCL trial. As Pharmacyclics or Janssen initiate specific clinical trials and enroll the 5th patient, additional milestone payments of $50 million may be triggered up to a total of $250 million.

The SPARK study is a single-arm, multi-center Phase II trial of ibrutinib in MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is overall response rate. The key secondary endpoints include overall survival rate, progression-free survival rate, and pharmacokinetic data of ibrutinib. This global study conducted by Janssen is planned to enroll 110 patients worldwide.

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