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Pharmacyclics' Ibrutinib Data Published

Zacks Equity Research

Pharmacyclics, Inc. (PCYC) recently announced that data from a study on its oncology candidate, ibrutinib, was published in Blood.

The study evaluated ibrutinib’s anti-tumor effect in patients suffering from mantle cell lymphoma (:MCL), a form of B-cell non-Hodgkin lymphoma that generally affects older adults.

The recently published data revealed that the lymphocytes that increased in the peripheral blood during treatment with ibrutinib are MCL cells rather than normal cells. The data was in context to previous study results which showed that after being treated with ibrutinib, absolute lymphocyte count (:ALC) increased in the peripheral blood in MCL patients.

The recent data further showed that ibrutinib directly and potently inhibits MCL cell adhesion and relocation in the existing lymph nodes/tissues. Moreover, other significant changes in nodal responses and markers of activation and growth were observed with continued treatment with ibrutinib.

We note that Pharmacyclics is seeking approval for ibrutinib in the U.S. for the MCL indication as well as for chronic lymphocytic leukemia (:CLL)/small lymphocytic lymphoma (:SLL).

Pharmacyclics’ regulatory submission in the U.S. for ibrutinib was based on positive results from the company’s phase II studies on the candidate in patients with MCL and relapsed/refractory CLL/SLL. Ibrutinib enjoys Breakthrough Therapy Designation in the U.S. for both indications.

Pharmacyclics is co-developing ibrutinib with Janssen Biotech, Inc., a Johnson & Johnson (JNJ) company. Pharmacyclics has received milestone payments of $200 million under its agreement with Janssen so far. Pharmacyclics is eligible to receive further payments of up to $625 million under the agreement. We expect investor focus to remain on the regulatory status of ibrutinib.

Pharmacyclics presently carries a Zacks Rank #2 (Buy). Meanwhile, other stocks such as Actelion Ltd. (ALIOF) and Gilead Sciences, Inc. (GILD) currently look more attractive with a Zacks Rank #1 (Strong Buy).

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