Abbott, Janssen, Pharmacyclics to collaborate on leukemia CDx

ABBOTT PARK, Ill.—Abbott has announced the establishment ofa collaboration with Janssen Biotech, Inc., one of the Janssen pharmaceuticalcompanies of Johnson & Johnson, and Pharmacyclics, Inc., a clinical-stagebiopharmaceutical company with a focus on small molecules for the treatment ofcancer and immune-mediated diseases. The three companies will examine thebenefits of using Abbott's proprietary fluorescence in-situ hybridization (FISH) technology to develop amolecular companion diagnostic test to aid in the identification of patientswith a specific genetic subtype of chronic lymphocytic leukemia (CLL), the mostcommon form of adult leukemia.

Per the terms of the agreement, Abbott will be responsiblefor developing a FISH-based test capable of identifying high-risk CLL patientswho present a deletion within a certain chromosome (17p (del17p)) and mayrespond to ibrutinib (PCI-32765), an oral, small-molecule inhibitor of Brutontyrosine kinase currently in development by Janssen and Pharmacyclics for thetreatment of non-Hodgkin's lymphoma, CLL and multiple myeloma.

"Like Abbott's other collaborations in the area of companiondiagnostics, our goal is to leverage molecular technologies to help ensure thatthe right medicine is getting to the right person," John Coulter, vicepresident of Molecular Diagnostics at Abbott, said in a press release regardingthe agreement. "Cancer is a complex disease where, historically, therapies havedemonstrated only a 25 percent efficacy rate. Companion diagnostic tests canhelp improve these outcomes by selecting patients that are more likely torespond to specific therapies, reducing time to the most effective treatmentand increasing the number of positive outcomes."

Abbott received clearance from the U.S. Food and DrugAdministration (FDA) in 2011 for its Vysis CLL FISH Probe Kit, which targetsmultiple genes including TP53 within the del17p region. The test is used tohelp determine likely prognosis for patients with CLL, and will be applied forinvestigational use only in these co-development efforts to determine geneticmarker status.

Janssen and Pharmacyclics began their worldwidecollaboration in December 2011, announcing that they would work together forthe development and commercialization of PCI-32765. Per the terms of theagreement, Pharmacyclics received an upfront payment of $150, with thepotential to receive up to an additional $825 million in development andregulatory milestone payments. The companies agreed to collaborate on thecompound's development for oncology and other indications, excludinginflammation and immune-mediated conditions, with each organization leadingdevelopment for specific indications. Janssen and Pharmacyclics are splittingdevelopment costs on a 60/40 basis, respectively.

Pharmacyclics announced in December that it had sharedresults for ibrutinib at the American Society of Hematology Annual Meeting,with the drug demonstrating "prolonged progression-free survival with amanageable and predictable safety profile in high unmet need indications:relapsed and refractory, high-risk, advanced CLL/SLL and MCL patients, and inaddition in treatment-naive elderly CLL patients." The company also announcedthis month that the FDA has granted Breakthrough Therapy Designation toibrutinib for the treatment of patients with relapsed or refractory mantle celllymphoma and for the treatment of patients with Waldenstrom's macroglobulinemia,which will help to accelerate the development and review of the drug for thispair of B-cell malignancy indications.