Ardea Biosciences, Inc. (Nasdaq:RDEA) 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.