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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