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Ardea Biosciences Reports Recent Accomplishments; Provides 2010 Outlook; Announces Fourth Quarter and Full-Year 2009 Financial Results and 2010 Financial Guidance
Date:3/12/2010

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  • The RDEA594 Phase 2 development program is nearing completion. We expect to provide in the near term, results from a Phase 2b single-agent dose-response study evaluating the safety and urate-lowering effects of 200 mg, 400 mg and 600 mg of RDEA594 in approximately 140 gout patients. In the second quarter of 2010, we expect to provide results from a Phase 2b combination study evaluating RDEA594 as an add-on to allopurinol in approximately 70 patients who do not respond adequately to allopurinol alone. Also in the second quarter, we expect to provide results from a small pharmacokinetic study of RDEA594 in subjects with moderate renal impairment.
  • We expect to obtain guidance from the US FDA and European Medicines Agency, and initiate the RDEA594 Phase 3 development program, in the second half of 2010.
  • In coordination with our commercial partner, Bayer HealthCare AG (Bayer), we intend to continue to progress RDEA119 in advanced cancer patients with different tumor types, as a single agent in the ongoing Phase 1 study as well as in combination with sorafenib (Nexavar®, Bayer HealthCare, Onyx Pharmaceuticals, Inc.) in the ongoing Phase 1/2 study.

Fourth Quarter and Year-End 2009 Financial Results and 2010 Financial Guidance


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Related medicine technology :

1. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
2. Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
3. Ardea Biosciences Lead MEK Inhibitor, RDEA119, to Enter Human Clinical Trials in Advanced Cancer Patients
4. Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout
5. Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus
6. Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load
7. Ardea Biosciences Presents Data Demonstrating Favorable Pharmacokinetics and Efficacy for Mitogen-Activated ERK Kinase (MEK) Inhibitors
8. Ardea Biosciences Appoints John W. Beck Chief Financial Officer, Announces Clinical Development Progress and Reports First Quarter 2008 Financial Results
9. Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594
10. Ardea Biosciences Presents Preclinical Data on RDEA119 Demonstrating Favorable Anti-Inflammatory Profile for Potential Use in Ulcerative Colitis
11. Ardea Announces Progress with HIV Non-Nucleoside Reverse Transcriptase Inhibitor Program
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