Ardea Biosciences, Inc 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 programme, 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."

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.

Ardea Biosciences of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of gout, human immunodeficiency virus (HIV), cancer and inflammatory diseases.