Further information about this trial can be found at www.clinicaltrials.gov: NCT01611090 – "A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"
About Janssen Collaboration
As previously announced on
December 8, 2011
, Pharmacyclics entered into a worldwide collaboration with Janssen to develop and commercialize ibrutinib (PCI-32765), a novel, oral, first-in-class Bruton's Tyrosine Kinase (BTK) inhibitor. Pharmacyclics received from Janssen an upfront payment totaling
upon signing the contract. With the dosing of a fifth patient in the CLL 3001 study, as announced today, a milestone payment of
has been earned. To date,
in milestones have been earned and Pharmacyclics may receive up to an additional
in development and regulatory milestone payments; for total potential upfront and milestone payments of
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 lead 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, with development costs shared on a 40/60 basis (Pharmacyclics 40% and Janssen 60%).
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our corporate mission statement reads as follows: To build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious medical healthcare needs. To identify promising product candidates based on exceptional scientific development expertise, develop our products in a rapid, cost-efficient manner and to pursue commercialization and/or development partners when and where appropriate. We exist to make a difference for the better and these are important times to do that.