Replies to post #153 on Pharmacyclics, Inc. (PCYC)

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Pharmacyclics Gets New Breakthrough-Therapy Designation for Ibrutinib

By Saabira Chaudhuri

Pharmacyclics Inc. (PCYC) said the U.S. Food and Drug Administration granted an additional breakthrough-therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17.

The designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Pharmacyclics noted patients harboring a deletion within chromosome 17 generally have poor response to chemoimmunotherapy and have limited treatment options.

Chronic lymphocytic leukemia is a slow-growing blood cancer that starts in the white blood cells. It is the second most common adult leukemia, and about 16,000 patients in the U.S. are diagnosed each year with this cancer, according to data cited by Pharmacyclics.

In February, the FDA granted breakthrough-therapy designations for ibrutinib as a monotherapy for the treatment of patients with relapsed or refractory mantle-cell lymphoma and as a monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia, both of which are also B-cell malignancies.

Ibrutinib is being developed jointly by Pharmacyclics and Janssen Biotech Inc., a unit of Johnson & Johnson (JNJ), to treat B-cell malignancies.

Shares of Pharmacyclics closed Friday at $75.55 and were inactive in recent premarket trading. The stock has more than doubled in the past 12 months.

Write to Saabira Chaudhuri at [e-mail].

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(END) Dow Jones Newswires

April 08, 2013 08:03 ET (12:03 GMT)

Copyright (c) 2013 Dow Jones & Company, Inc. 040813 12:03 -- GMT Story ID: APR082013_DJB_010v Keywords: ALL COMPANY NEWS, NEW PRODUCTS & SERVICES, HEALTH CARE Symbols: JNJ, PCYC

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6:31AM Pharmacyclics announces NDA filing for ibrutinib accepted in two B-cell malignancies by the FDA; triggers a $75 mln milestone payment to the co (PCYC) 111.70 : Co announced that the FDA has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma and previously treated chronic lymphocytic leukemia /small lymphocytic lymphoma. On June 28, 2013 Pharmacyclics submitted a NDA under section 505(b) of the Food, Drug & Cosmetic Act for ibrutinib. On Aug 27, 2013 the FDA notified Pharmacyclics that they have completed their filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA's acceptance of the NDA triggers a $75 mln milestone payment to Pharmacyclics under its Collaboration Agreement with Janssen Biotech, a subsidiary of Johnson & Johnson (JNJ)