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Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient in Frontline Phase III CLL Study
Date:4/11/2013

act. With the dosing of a fifth patient in the RESONATE™-2 study, as announced today, a milestone payment of $50 million has been earned. To date, $200M in milestones have been earned and Pharmacyclics may receive up to an additional $625 million in development and regulatory milestone payments; for total potential upfront and milestone payments of $975 million.

Following regulatory approval, both Pharmacyclics and Janssen will book revenue and co-commercialize ibrutinib. In the US, Pharmacyclics will book sales and take the lead role in US commercial strategy development. Both Pharmacyclics and Janssen will share in commercialization activities. Outside the United States, Janssen will book sales and perform commercialization activities. Profits and losses from the commercialization activities will be split 50/50 on a worldwide basis. Development and commercialization activities under the collaboration will be managed through a shared governance structure. Each company will lead development for specific indications as stipulated in a global development plan. Except in certain cases, in general, development costs are shared on a 40/60 basis (Pharmacyclics 40% and Janssen 60%).

About Ibrutinib
Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib. Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, adhesion, and cell migration and homing. Through these multiple signals, BTK regulation helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro environment necessary for survival.

The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell mali
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SOURCE Pharmacyclics, Inc.
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