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Pharmacyclics Reports First Quarter 2013 Results
Date:5/1/2013

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The Breakthrough Therapy Designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. Pharmacyclics, together with Janssen, is working with the FDA to determine the implications of this Breakthrough Therapy Designation to the ongoing and planned development and the filing requirements for the use of ibrutinib in patients. At this time Pharmacyclics is targeting to submit the MCL filing before the end of the third quarter 2013. Pharmacyclics anticipates to provide guidance prior to year end on the WM and CLL with deletion 17p filing timelines after further discussions with the FDA.

The FDA Breakthrough Therapy Designations for ibrutinib were based on data from clinical and pre-clinical studies. Ibrutinib has the potential to improve the outcome in these serious and life-threatening diseases which have a poor prognosis. The company and its collaboration partner, Janssen, have designed and are currently executing a development program for ibrutinib in each of these indications.

Comprehensive Pre-Clinical Research and Clinical Development To broaden our understanding of ibrutinib, Pharmacyclics has performed research into mechanisms of action both in its own research department, and through collaborations with leading universities and clinical centers. Over the past 3 years, Pharmacyclics' research department has established and maintained 47 collaborations with academic investigators at universities or clinical centers. This broad-reaching collaborative effort has resulted
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SOURCE Pharmacyclics, Inc.
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