BERKELEY, Calif.--(BUSINESS WIRE)--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.
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.
About PLX4032 (RG7204)-A Personalized Medicine for Cancer Treatment
PLX4032 is a novel, oral small molecule for melanoma and other cancers harboring the oncogenic BRAF mutation. Plexxikon utilized its structure-guided chemistry platform to discover PLX4032, and initiated clinical development in 2006. A DNA-based companion diagnostic to identify patients whose tumors carry BRAF mutation is being co-developed by Plexxikon and Roche Molecular Diagnostics in parallel with the therapeutic development of PLX4032.
Plexxikon is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company's lead compound, PLX4032, is in late-stage clinical trials for the treatment of melanoma. The company is developing a portfolio of clinical and preclinical stage compounds to address significant unmet medical needs in cardio-renal disease, CNS disorders, autoimmune and neuro-inflammatory diseases, and oncology. Plexxikon's proprietary Scaffold-Based Drug DiscoveryTM platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant competitive advantage over other drug discovery approaches. For more information, please visit www.plexxikon.com.