The Company expects to end calendar year 2013 with cash, cash equivalents and marketable securities of more than $225 million.
"Ibrutinib has demonstrated great clinical progress during this past year. Today we have a very solid development program in place with 5 Phase III trials initiated and several more trials to be started this year. We were honored to announce this past Tuesday that ibrutinib received Breakthrough Designation in two B-cell malignancies. We look forward to working with the FDA to bring this therapy to market in a timely manner," said Bob Duggan, CEO and Chairman of the Board. "Looking ahead, our goals for this year are star high as we are continuing to unfold our clinical program. With our partner Janssen, we are committed to a shared vision of patient friendly, body harmonious solutions intended to improve the quality of life, increase duration of life and resolve serious medical health care needs for patients."
Recent Developments & HighlightsBreakthrough Therapy Designation
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.
|SOURCE Pharmacyclics, Inc.|
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