Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma. PLX4032 was discovered by Plexxikon and is being co-developed with Roche, and now Genentech, a member of the Roche Group, under a 2006 license and collaboration agreement between Plexxikon and Roche.
“As a targeted oncology therapy expected to launch with a companion diagnostic, PLX4032 represents a new era in personalized medicine. We are very excited for the unique opportunity that co-promotion of PLX4032 represents.”
Under the agreement with Genentech, Plexxikon will provide a specialty sales force to co-promote PLX4032 in the U.S. Additionally, Plexxikon will reimburse Genentech for certain marketing and promotion costs related to the brand. In exchange, Plexxikon will be entitled to receive enhanced royalties on product sales.
“We are pleased to announce this agreement, which enables Plexxikon’s first step towards building a commercial franchise in oncology,” said Kathleen Sereda Glaub, president of Plexxikon. “As a targeted oncology therapy expected to launch with a companion diagnostic, PLX4032 represents a new era in personalized medicine. We are very excited for the unique opportunity that co-promotion of PLX4032 represents.”
PLX4032 is currently being tested in a randomized, controlled Phase 3 trial of approximately 680 previously untreated BRAF mutation-positive, metastatic melanoma patients. In November 2010, Plexxikon announced positive data from a Phase 2 clinical trial of previously treated metastatic melanoma patients, showing a 52 percent response rate and tumor shrinkage in the majority of patients.
Combination trials with PLX4032 are planned, including a trial to begin in the first quarter of 2011 that will combine PLX4032 and an oral, small molecule MEK inhibitor (RG7420/GDC-0973) in melanoma patients with the BRAF mutation. Trials in other BRAF-mutated cancers are also being planned, including for thyroid, adjuvant melanoma and colorectal cancer.
In addition to PLX4032, Plexxikon has a pipeline of additional products in development and pre-development, including multiple agents for the treatment of cancer. PLX3397 is an oral, selective kinase inhibitor co-targeting FMS, Kit and Flt3-ITD, and is currently in the late stages of a Phase 1 dose escalation trial. The company plans to initiate several Phase 2 trials with PLX3397 in specific cancers this year.