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Positive Data on PCYC's Ibrutinib

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Pharmacyclics, Inc. 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.

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, Inc., a Johnson & Johnson (JNJ - Free Report) 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 attractive, include Athersys Inc. (ATHX - Free Report) and Celgene Corporation (CELG - Free Report) . While Athersys carries a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy).

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