(Source: Business Wire)
Ardea Biosciences, Inc. (Nasdaq: RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, human immunodeficiency virus (HIV), cancer and inflammatory diseases, today reported recent accomplishments and financial results for the first quarter ended March 31, 2009 and announced a restructuring of operations. The restructuring is intended to conserve financial resources by focusing the Company on its clinical-stage programs.
"Ardea is off to an excellent start in 2009. Since our last quarterly update, we have reported positive clinical trial results for RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, and announced a global agreement with Bayer HealthCare focused on the development and commercialization of small-molecule, mitogen-activated ERK kinase inhibitors for the treatment of cancer," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "We plan to initiate a broad-based Phase 2 program for RDEA594 this quarter, which, if successful, will position us to initiate pivotal Phase 3 trials in 2010. From a financial perspective, we expect that our current financial resources, plus the $35 million upfront payment from Bayer, combined with the savings generated from our restructuring, will allow us to fund operations through the first quarter of 2011. This current financial projection does not include any milestone payments under our global agreement with Bayer, proceeds from future partnering activities or financings."
Recent Accomplishments
On April 28, 2009, we announced a global agreement with Bayer to develop and commercialize small-molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of cancer. Under the terms of the agreement, we granted to Bayer a worldwide, exclusive license to develop and commercialize our MEK inhibitors for all indications. Our lead product candidate from this program, RDEA119, is currently being evaluated both as a single agent and in combination with sorafenib (Nexavar®; Bayer HealthCare, Onyx Pharmaceuticals) in advanced cancer patients. Bayer has agreed to pay us a non-refundable, upfront license fee of $35 million for the development and commercialization rights to our MEK inhibitors. Potential payments under the agreement could total up to $407 million, not including royalties. We will also be eligible to receive low double-digit royalties on worldwide sales of products under the agreement.
On April 20, 2009, we presented positive results from a multiple-ascending-dose Phase 1 clinical trial of RDEA594 in normal healthy volunteers at an investor and analyst event. In this study, RDEA594 produced statistically significant, dose-dependent reductions in uric acid of up to 45% after 10 days of treatment at the highest dose evaluated. RDEA594 also was safe and well-tolerated in the study.
At the same event, we presented data from our Phase 2a proof-of-concept study of RDEA594's prodrug, RDEA806, in the target population of patients with hyperuricemia (uric acid greater than or equal to 8 mg/dl) and a history of gout. Results from this study showed that RDEA594, when administered as its prodrug, RDEA806, produced statistically significant, dose-dependent reductions in uric acid of up to approximately 40% after 28 days of treatment in the twice-daily dosing group. These reductions were consistent with those seen in previous studies of RDEA806 in normal healthy volunteers. RDEA806 also was safe and well-tolerated in the study.
On April 21, 2009, we presented data from preclinical studies of RDEA119, demonstrating synergy when administered in combination with multiple anticancer agents in vivo, at the American Association for Cancer Research 100th Annual Meeting.
Important Upcoming Development Milestones
We plan to initiate a comprehensive Phase 2 program to demonstrate the broad clinical utility of RDEA594 in the treatment of hyperuricemia and gout in the second quarter of 2009. Initial results from this program are expected in the fourth quarter of 2009.
