Pharmacyclics, Inc. (PCYC) recently announced the enrollment of the fifth patient in a phase III study, RESONATE-2, which is being conducted to evaluate ibrutinib as a monotherapy versus chlorambucil in elderly patients suffering from chronic lymphocytic leukemia (:CLL)/small lymphocyctic lymphoma (:SLL).
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. RESONATE-2 will enroll 272 patients worldwide.
Pharmacyclics and Janssen’s agreement dates back to Dec 2011. The companies are collaborating for the global development and commercialization of ibrutinib. In addition to receiving a $150 million upfront payment from Janssen, Pharmacyclics is entitled to receive another $825 million on the achievement of development and regulatory milestones.
On Aug 1, 2012, Pharmacyclics had announced the enrollment of the fifth patient in a phase III study, RESONATE, which is conducted to evaluate ibrutinib versus ofatumumab in patients with relapsed or refractory CLL/SLL. This led to the first milestone payment of $50 million for Pharmacyclics from Janssen.
On Aug 20, 2012, Pharmacyclics became eligible to receive its second milestone payment of $50 million as a result of enrolling the fifth patient in a phase II study, SPARK, which is conducted to evaluate ibrutinib in patients suffering from relapsed or refractory mantle cell lymphoma (:MCL).
The third milestone payment of $50 million was triggered on Oct 15, 2012, when Pharmacyclics announced the enrollment of the fifth patient in an international, randomized phase III clinical trial of ibrutinib in combination with bendamustine and rituximab in patients with relapsed or refractory CLL/SLL.
Thus, out of $825 million, $200 million of milestones have already been earned by Pharmacyclics to date.
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