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

class="prnews_span">-15,415-100,190-150,259-Janssen's share of pre-tax profits

50%50%50%50%Total Cost of collaboration (Janssen's 50% share as per the Agreement)

$
50,095
$
-
$
75,130
$
-
Pharmacyclics' 50% share of net product revenue less cost of goods sold

$
50,095
$
-
$
75,130
$
-
(3)The Company's total share of net costs under the Agreement did not exceed the $50 million annual cap provided for in the Agreement. As such, no Excess Amounts were recorded for the three and six months ended June 30, 2014. Regulatory UpdateOn July 28, 2014, the U.S. FDA granted IMBRUVICA full approval for the treatment of CLL patients who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive (frontline) and previously treated del 17p CLL patients. This was the first full FDA approval for IMBRUVICA, and was granted only five and a half months after the original accelerated approval for patients with previously treated CLL, which was granted in February 2014. 

This full approval is based on data from the Phase III RESONATE study (PCYC-1112-CA), a randomized, multi-center, international head-to-head comparison of single-agent, orally-administered IMBRUVICA (ibrutinib) versus the intravenous, monoclonal an
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SOURCE Pharmacyclics, Inc.
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