Ardea Biosciences and Bayer HealthCare Enter into Global Agreement Focused on the Development of MEK Inhibitors for the Treatment of Cancer
On Tuesday April 28, 2009, 8:30 am EDT
Ardea Biosciences, Inc.
SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq:RDEA - News) today announced that it has entered into a global agreement with Bayer HealthCare focused on the development of small molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of cancer. The lead compound in this program, RDEA119, is currently being evaluated in advanced cancer patients as a single agent in a Phase 1 study and in a Phase 1/2 study in combination with sorafenib (Nexavar®, Onyx Pharmaceuticals, Bayer HealthCare).
Under the terms of the agreement, Ardea will grant Bayer a worldwide, exclusive license to develop and commercialize Ardea’s MEK inhibitors for all indications. Potential payments to Ardea under the agreement could total up to $407 million, not including royalties. This amount includes an upfront cash payment to Ardea of $35 million, as well as additional cash payments upon achievement of certain development, regulatory and sales-based milestones. Ardea is also eligible to receive low double-digit royalties on sales of products under the agreement.
Ardea will be responsible for the completion of the Phase 1 and Phase 1/2 studies currently being conducted for RDEA119. Thereafter, Bayer will be responsible for the further development and commercialization of RDEA119 and any of Ardea’s other MEK inhibitors. The agreement announced today is subject to all necessary authorizations, consents or clearances of governmental authorities.
“RDEA119 has demonstrated compelling synergistic activity in vitro in combination with sorafenib, as well as other approved anti-cancer agents, and we look forward to working with Bayer as a globally successful company in the field of targeted anti-cancer therapies to evaluate multiple drug combinations in several cancer indications,” commented Barry D. Quart, Ardea’s president and chief executive officer.
“We are very excited about the potential use of MEK inhibitors to treat a broad range of cancer indications,” stated Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. “We are looking forward to working with Ardea’s team on the development of novel cancer treatments for patients.”
About RDEA119, RDEA436 and Ardea’s Other MEK Inhibitors
RDEA119, a non-ATP competitive, highly-selective MEK inhibitor for the treatment of cancer and inflammatory diseases, is Ardea's lead compound from its MEK inhibitor research and development program. MEK is believed to play an important role in cancer cell proliferation, apoptosis and metastasis, as well as inflammation. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects. Ardea has also designed a portfolio of next generation MEK inhibitors from chemical classes that are distinct from the RDEA119 chemical class. The most advanced of these compounds is RDEA436, which has been evaluated in a human micro-dose pharmacokinetic study.
surf's up......crikey
