California, USA-based Pharmacyclics (Nasdaq: PCYC) announced yesterday that the SPARK (MCL2001) clinical trial of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient, triggering a second $50 million milestone payment from Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ) under a collaboration signed last year worth a potential of nearly $1 billion (The Pharma Letter December 9, 2011).
As Pharmacyclics or Janssen initiate specific clinical trials and enroll the fifth patient, additional milestone payments of $50 million may be triggered up to a total of $250 million, the company noted. The earlier milestone was the result of enrolment of the fifth patient in the international Phase III randomized, multicenter, open-label clinical trial, RESONATE (PCYC-1112), of ibrutinib versus ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia (TPL August 3).
"We formed this partnership with Janssen, with the intention to broadly expand and propel the clinical development of ibrutinib. The speed at which we have moved into important clinical trials in CLL and now MCL is a validation of this joint venture's ability to convert plans into actualities," said Bob Duggan, chairman and chief executive of Pharmacyclics, adding: "We are satisfied with the early progress this partnership is generating and we look forward to providing a material update in December, during the American Society of Hematology Meeting."
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