Pharmacyclics, Inc. (PCYC) recently announced the enrollment of the fifth patient in a phase II study that is being conducted with ibrutinib in patients suffering from relapsed or refractory mantle cell lymphoma (:MCL). With the enrollment of the fifth patient, Pharmacyclics is eligible to receive a $50 milestone payment from partner, Janssen Biotech, Inc., a Johnson & Johnson (JNJ) company.
The single-arm, multi-center phase II study, SPARK (MCL2001), is being conducted in MCL patients who have been treated with at least one prior rituximab-containing chemotherapy regimen and who progressed after treatment with bortezomib. While overall response rate is the primary endpoint, secondary endpoints include overall survival rate, progression-free survival rate, and pharmacokinetic data.
Pharmacyclics and Janssen’s agreement dates back to December 2011. The companies are collaborating for the global development and commercialization of ibrutinib. Besides receiving a $150 million upfront payment from Janssen, Pharmacyclics is entitled to receive another $825 million on the achievement of development and regulatory milestones.
With the triggering of the $50 million milestone payment for the SPARK study, Pharmacyclics has already earned $100 million in the form of development milestones. This includes a $50 million milestone payment that was triggered earlier this month with the enrollment of the fifth patient in another study (RESONATE (PCYC-1112)) with ibrutinib.
The international phase III randomized, multicenter, open-label RESONATE study is being conducted in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
We currently have a Neutral recommendation on Pharmacyclics, which carries a Zacks #2 Rank (short-term ‘Buy’ rating). We are positive on the company’s collaboration with Janssen for ibrutinib. Janssen is a suitable partner for Pharmacyclics. Janssen’s strong global presence bodes well for the commercialization of ibrutinib, once it is approved.
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