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Pharmacyclics Reports Third Quarter 2013 Results
Date:11/7/2013

clinical accomplishments are ahead of our internal expectations," said Bob Duggan, CEO and Chairman of the Board."Most recently we achieved an important milestone with ibrutinib's drug application now being submitted to the European authorities. Together with Janssen, our partner, we are working towards a broad clinical advancement of ibrutinib and have now focused in on making the product commercially available in all major markets around the world. Over the next several quarters, we are anticipating additional clinical and regulatory progress. We are on our way to becoming a true ally for patients and physicians, addressing serious, unmet medical health care needs for patients."

Regulatory and Clinical UpdateTo date, over 2300 patients have been treated in company sponsored trials, over 800 principal investigators have been involved in the conduct of our clinical trials in 37 countries around the globe. Clinical trials are active in all regions including US, Europe, Asia Pacific, Asia, and Latin America. Currently there are eight Phase III clinical trials conducted with ibrutinib and a total of 35 trials are currently registered on www.clinicaltrials.gov.

On October 30, Janssen announced it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of ibrutinib in the treatment of adult patients with R/R CLL/SLL or R/R MCL, two forms of blood cancer. The EMA filings follow the New Drug Application submission of ibrutinib to the U.S. Food and Drug Administration which was accepted by the agency on August 27, 2013, for its use in the treatment of patients with R/R CLL/SLL or R/R MCL.

Oral Presentations at ASH (December 7-10) for ibrutinibTen Oral Presentations and eleven Poster Presentations for ibrutinib have been accepted at the American Society of Hematology (ASH) Annual Meeting in New Orleans, LA (December 7-10, 2013). These abstracts w
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