Plexxikon and Roche Enter Partnership to Develop Targeted Cancer Therapeutic Medicine PLX4032
Wednesday October 4, 11:45 am ET
BERKELEY, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Plexxikon Inc. and Roche today announced they have entered into an agreement to develop and commercialize PLX4032, Plexxikon's investigational targeted cancer therapy which selectively inhibits B-Raf(V600E), a mutated form of the BRAF kinase gene. The BRAF(V600E) gene has been associated with increased tumor aggressiveness and decreased survival in many types of cancers and is a common cancer-causing kinase gene. The BRAF(V600E) gene is found in approximately 70% of malignant melanomas and a large number of colorectal and thyroid tumors. PLX4032 may offer a new treatment modality for the estimated 100,000 cancer patients in the United States who carry the BRAF(V600E) gene. Plexxikon recently filed an Investigational New Drug (IND) application for PLX4032 and plans to initiate a Phase 1 clinical trial by the end of this year.
Separately, Roche Molecular Diagnostics, a business unit of Roche Diagnostics, and Plexxikon announced they will collaborate on development of an in vitro assay to screen for the presence of the BRAF(V600E) mutation in biological samples taken from patient tumors. An assay that correlates the presence of this mutation with clinical outcome may aid clinical development of PLX4032.
"As one of the leading pharmaceutical companies in oncology, together with their commitment to personalized medicine, Roche makes an ideal partner for the development of this unique compound," said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon Inc. "We believe PLX4032 could be a first-in-class oral cancer therapeutic which selectively targets an oncogenic protein found only in diseased tissue. Along with our Phase 2 diabetes product and preclinical stage portfolio in multiple therapeutic areas, PLX4032's entry into development further validates Plexxikon's discovery platform for novel drug candidates."
"There is a growing body of evidence demonstrating that agents such as PLX4032, which selectively inhibit activated kinases, are increasingly useful in treating cancer and improving patient outcomes," said Peter Hug, Roche's Global Head of Pharma Partnering. "We are very excited to partner with Plexxikon for the development of PLX4032 and other B-Raf(V600E) targeted compounds. This could be a further example of the potential of personalized medicine. With our combined expertise in diagnostic and therapeutic development as well as commercialization, we are confident in our capability to develop this potential drug to make a difference to patients' lives."
Plexxikon Roche Collaboration
Under the terms of the agreement, Roche will pay Plexxikon $40 million as an upfront payment and a further $6 million in guaranteed research funding over the next two years. In addition, Plexxikon could potentially receive up to approximately $660 million over the term of the collaboration based on the successful completion of a series of development and commercial milestones for multiple indications and/or multiple compounds, as well as royalties on potential product sales.
Also under the collaboration, Roche and Plexxikon will jointly develop PLX4032 and follow on compounds targeting other BRAF kinase mutations. Plexxikon has filed an IND application for PLX4032, and will conduct a Phase 1 dose escalation study in patients with cancer, including melanomas. Roche will have a worldwide, exclusive license to develop and commercialize PLX4032, in addition to other anticancer compounds resulting from the partnership. Plexxikon retains the right to co-promote any product in the collaboration in the United States.
About PLX4032
PLX4032 is a selective inhibitor of the B-Raf(V600E) kinase found in approximately 70% of malignant melanomas, a large percentage of colorectal and thyroid cancers and many other tumor types. In preclinical studies in both melanoma and colorectal cancer models, PLX4032 reduces tumor size and slows the progression of the tumors even after the completion of treatment, without evidence of side effects. Highly selective against B-Raf(V600E) compared to a panel of over 70 other kinases, PLX4032 is designed to work specifically on cancer cells, leaving healthy cells untouched in contrast to chemotherapeutic agents.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, a leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totaled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
Plexxikon Profile
Plexxikon is a leader in the discovery and development of novel small molecule pharmaceuticals to treat human disease. Plexxikon's proprietary Scaffold-Based Drug Discovery(TM) platform is being applied to build therapeutic franchises in metabolic and cardiovascular disease, inflammation and oncology. This discovery process integrates a number of state-of-the-art technologies, including structural screening as one key component that provides a significant competitive advantage over other drug discovery approaches. To date, the company has discovered a portfolio of clinical and preclinical stage compounds in each of these franchises.
Currently, the company's most advanced program is a PPAR pan-agonist for the treatment of diabetes and related cardiovascular complications, with the lead candidate now in Phase 2 clinical testing in collaboration with Wyeth Pharmaceuticals. Other discovery programs include a dual kinase inhibitor for the treatment of rheumatoid arthritis and other inflammatory diseases and a renin inhibitor for hypertension in collaboration with Servier. Plexxikon is seeking pharmaceutical and biotechnology partners for select collaboration opportunities. For more information, please visit www.plexxikon.com. |
