Ardea Biosciences to Present Results from a Phase 2a Study of RDEA594 at the 2009 ACR/ARHP Annual Scientific Meeting

SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced that it will present results from a Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, at the 2009 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.

Previously disclosed interim results will be updated to include final single-agent cohort data, as well as data demonstrating RDEA594’s ability to lower serum urate to less than 6.0 mg/dL in patients with mild to moderate renal insufficiency, which was the majority of patients randomized to RDEA594. In addition, the company will provide an update on improved drug formulations and will present data from a preclinical drug-drug interaction study demonstrating RDEA594’s potential to be used in combination with allopurinol and febuxostat (Uloric^®, Takeda Pharmaceutical Company Limited; Adenuric^®, Ipsen), both of which lower serum urate via a different mechanism of action than RDEA594.

About RDEA594 and RDEA684

RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is a selective URAT1 transporter inhibitor that is in Phase 2 development as a single agent and in combination with the approved xanthine oxidase inhibitors, allopurinol and febuxostat (Uloric^®, Takeda Pharmaceutical Company Limited; Adenuric^®, Ipsen). Over 300 people have safely received RDEA594, either by direct administration or through administration of RDEA806, its prodrug. We have selected a next-generation URAT1 inhibitor, RDEA684, as a development candidate and expect to begin a Phase 1 study of RDEA684 in 2010. Based on preclinical results, RDEA684 demonstrates many of the same positive attributes as RDEA594, but with more than 170-times greater potency against the URAT1 transporter.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer, inflammatory diseases and human immunodeficiency virus (HIV). RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is a selective URAT1 transporter inhibitor in Phase 2 clinical development. Our next-generation URAT1 inhibitor, RDEA684, is currently in preclinical development. RDEA119, a potent and specific inhibitor of mitogen-activated ERK kinase (MEK) and our lead product candidate for the treatment of cancer, is being developed under a global license agreement with Bayer HealthCare. RDEA119 is being evaluated as a single agent in a Phase 1 study in advanced cancer patients and in a Phase 1/2 study in combination with sorafenib (Nexavar^®; Bayer HealthCare, Onyx Pharmaceuticals) in advanced cancer patients. RDEA119 has also been evaluated for potential use in inflammatory diseases in a Phase 1 study in normal healthy volunteers. RDEA806, our lead product candidate for the treatment of HIV, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that has successfully completed a Phase 2a study in HIV patients.

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our plans and goals, the expected properties and benefits of RDEA594, RDEA684, RDEA119, RDEA806 and our other compounds and the timing and results of our preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, costs associated with our drug discovery and development programs, and risks related to the outcome of our business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Ardea Contact:
Ardea Biosciences, Inc.
John Beck, 858-652-6523
jbeck@ardeabio.com
or
Media Contact:
Russo Partners, LLC
Heidi Chokeir, Ph.D., 619-528-2217
heidi.chokeir@russopartnersllc.com