NEW BRUNSWICK (dpa-AFX) - Pharmacyclics Inc. (PCYC), announced that it has entered into a worldwide collaboration with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize PCI-32765, a novel, oral, first-in-class Bruton's tyrosine kinase or Btk inhibitor being developed for the treatment of Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma, all of which are considered hematological malignancies.
PCI-32765 was developed by Pharmacyclics and is currently in Phase II clinical trials.
As per the agreement, Pharmacyclics noted that it will receive an upfront payment of $150 million. In addition, Pharmacyclics will receive up to an additional $825 million in development and regulatory milestone payments, based upon continued development, regulatory progress and approval of the product, for total potential upfront and milestone payments of $975 million.
Pharmacyclics and Janssen will collaborate on the development of PCI-32765 for oncology and other indications, excluding inflammation and immune mediated conditions. 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%).
The agreement includes plans to launch multiple Phase III trials of PCI-32765 over the next several years.
According to the terms of the agreement, the companies have entered into a worldwide 50/50 profit-loss agreement, sharing development and commercialization activities. This transaction is expected to have a dilutive impact to Johnson & Johnson's 2011 earnings per share of approximately $0.04 - $0.05.
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