) recently presented encouraging data from a phase II study which
evaluated its cancer candidate ibrutinib as a monotherapy in
patients suffering from chronic lymphocytic leukemia (CLL).
Results from the study revealed that treatment with ibrutinib
resulted in rapid and sustained control of the cancer in
untreated, relapsed and refractory patients, irrespective of
characteristics that predict poor outcomes to chemoimmunotherapy.
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Pharmacyclics presented the data at the annual meeting of the
American Association for Cancer Research in the US. We note that
the phase II study on ibrutinib evaluated CLL patients in two
groups. While one group included 24 CLL patients (of which 8 were
treatment naive) aged above 65 years, the other cohort included
29 CLL patients (15 were treatment naïve) with a deletion of
chromosome 17p. Patients in the second group (the high risk
genetic cohort) historically respond unsatisfactorily to
chemoimmunotherapy and have limited treatment options.
Successful development and commercialization of ibrutinib would
bring in substantial revenues to Pharmacyclics since the CLL
market offers significant commercial potential. The candidate is
being developed to treat other cancer forms as well.
Pharmacyclics is co-developing ibrutinib with Janssen Biotech,
Johnson & Johnson
) company. 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.
In another positive development, the US Food and Drug
Administration (FDA) granted breakthrough therapy designation to
ibrutinib for treating CLL/small lymphocytic lymphoma patients
with a deletion of chromosome 17p. Earlier in the year, the US
regulatory body granted breakthrough therapy designation to
ibrutinib for treating mantle cell lymphoma patients as a
monotherapy. The FDA granted a similar status to the candidate
for treating patients suffering from Waldenström's
macroglobulinemia also as a monotherapy. We expect investors'
focus to remain on the development of ibrutinib.
Pharmacyclics, a biopharmaceutical company, carries a Zacks Rank
#3 (Hold). Biopharmaceutical stocks, which currently look more
). While Athersys carries a Zacks Rank #1 (Strong Buy), Celgene
carries a Zacks Rank #2 (Buy).