genmab

Genmab Darzalex success triggers second milestone payment

pharmafile | March 10, 2016 | News story | Research and Development, Sales and Marketing Genmab, Janssen, daratumumab, darzalex, follicular lymphoma 

Genmab says it has reached a $5 million milestone in its daratumumab collaboration with Janssen as a result of success in a trial of the drug in patients with follicular lymphoma (FL),

This is the second milestone payment triggered by progress in the ongoing Phase II study (Carina LYM2001), which is evaluating Darzalex (daratumumab) in various forms of non-Hodgkin’s lymphoma (NHL). Last Novemebr, Janssen paid Genmab $45 million when the first commercial sale of the drug was made in the US.

The study evaluates Darzalex as a monotherapy in three different types of NHL: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL). The milestone payment is related to progress in the arm of the study treating patients with FL.

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Janssen is developing, manufacturing and commercialising Darzalex under an exclusive worldwide license, having signed an agreement with Genmab in 2012. At this time, Janssen paid $55 million upfront in an agreement potentially worth as much as $1.1 billion.

“The daratumumab study in NHL is now underway, and we are very pleased to have achieved milestones for progress in two of the disease areas included in the study, FL and DLBCL,” says Jan van de Winkel, chief executive of Genmab.  “We remain optimistic about the therapeutic potential of daratumumab in indications outside of multiple myeloma.”

Darzalex has received Orphan Drug designation from the US FDA for DLBCL, FL and MCL. The Agency approved the drug for multiple myeloma last November.

Joel Levy

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