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Pharmacyclics Reports Second Quarter 2014 Results
Date:7/31/2014

e opinion was based on data from the Phase II study (PCYC-1104) in MCL, a Phase III RESONATE™ study (PCYC-1112-CA) and a Phase II study (PCYC-1102) in CLL.

The EMA is a decentralized agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the 28 countries of the European Union. The positive opinion of the EMA's CHMP will be reviewed by the European Commission, and a final decision on IMBRUVICA is anticipated later this year. In addition to European markets, a worldwide regulatory filing program for IMBRUVICA currently is underway.

Clinical UpdateIMBRUVICA (ibrutinib) clinical trials are active in all regions including US, Europe, Asia Pacific, Canada and Latin America. Currently IMBRUVICA is being developed in 8 different B-cell malignancies. There are 12 Phase III clinical trials initiated with IMBRUVICA and a total of 50 trials are registered on www.clinicaltrials.gov, of which 23 are investigating combination regimens while the remaining 27 are investigating IMBRUVICA monotherapy. The total planned enrollment for all of our clinical studies investigating IMBRUVICA is approximately 7,200 patients. As of today there are seven Phase III studies focused on patients with CLL, two designed for patients with MCL, one for patients with diffuse large B-cell lymphoma, one for patients with follicular lymphoma and one for Waldenstroms macroglobulinemia. To date, over 3,300 patients have been treated in Company-sponsored trials which are being conducted in over 35 countries around the globe and which involve more than 800 principal investigators.

During the second quarter, we initiated a Company-sponsored, randomized, double-blind, placebo-controlled, Phase III study of IMBRUVICA or placebo in combination with rituximab in previously treated Waldenstrom's Macroglobulinemia patients. The total planned enrollment for this study i
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SOURCE Pharmacyclics, Inc.
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