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New Drug Application for Ibrutinib Submitted to the U.S. FDA
Date:7/10/2013

h Therapy Designations just this past February and since then published various clinical results in patients with CLL del17p and also in patients with Waldenstroms; in April we completed enrollment of our first Phase III study; last month, results of two of our trials were published in the prestigious New England Journal of Medicine and today Pharmacyclics announced the filing of its first NDA for ibrutinib with the Food and Drug Administration," said Bob Duggan CEO and Chairman of Pharmacyclics. "Thus far, more than 1600 patients have been treated in our studies with ibrutinib and we are making excellent progress in the development and preparation for commercialization of this investigational drug. As of today, we have initiated 7 Phase III studies together with our partner Janssen and have currently registered with the US National Institute of Health 31 clinical trials using ibrutinib. It is Pharmacyclics's goal to advance science and drug development in the hopes of making a significant difference for the betterment of patients with serious unmet healthcare needs, and with the announcement today we have accomplished an important milestone in our timeless journey."

About CLL / SLL
CLL, a B-cell malignancy, is a slow-growing blood cancer that starts in the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 15,680 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the U.S. It is a chronic disease of the elderly with a five-year survival of approximately 82 percent.1 Patients commonly receive multiple lines of treatment over the course of their disease. When cancer cells are located mostly in the lymph nodes, the disease is called SLL. CLL and SLL are considered to be different manifestations of the same underlying disease; they share similarities in signs and symptoms, genetic features, disease progression and treatme
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SOURCE Pharmacyclics, Inc.
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