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Ardea Biosciences Awarded Composition of Matter Patent Covering RDEA806, Its Lead NNRTI for the Treatment of HIV


Tuesday, October 21, 2008

San Diego, CA -- Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that the United States Patent and Trademark Office has issued a patent covering the composition of matter of RDEA806, the Company’s lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of patients with human immunodeficiency virus (HIV), and related analogs. U.S. Patent No. 7,435,752 was issued on October 14, 2008.

"We are very pleased with the continued expansion of our proprietary position in the NNRTI area. This issued patent significantly enhances the value of RDEA806 and strengthens our ability to enter into future strategic alliances for its further development," commented Barry D. Quart, PharmD, Ardea’s president and chief executive officer. "We look forward to further expanding the proprietary position of RDEA806 and our other product candidates through additional future patent issuances."

About RDEA806

RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV infection. Based on preclinical and clinical studies to-date, we believe that RDEA806 may have important competitive advantages compared to currently available NNRTIs. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to Sustiva® (efavirenz) and other currently available NNRTIs; a high genetic barrier to resistance; no reproductive toxicity based on animal studies; the potential to be administered in a patient-friendly, oral dosing regimen; limited pharmacokinetic interactions with other drugs; and the ability to be co-formulated with other HIV antiviral drugs.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have five product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of gout, is being evaluated in a Phase 1 clinical trial and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1/2 study in combination with Nexavar® (sorafenib) and as a single agent in a Phase 1 study, both in advanced cancer patients, and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development.

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 goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the results of 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, and costs associated with our drug discovery and development programs and 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.



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