Ardea Biosciences earned a $15 million milestone payment from Bayer HealthCare under the terms of their April 2009 global license agreement to develop and commercialize Ardea’s mitogen-activated ERK kinase (MEK) inhibitor compounds for cancer and other indications. This milestone was triggered by the initiation of a Phase II clinical study evaluating BAY 86-9766 in combination with sorafenib (Nexavar®; Bayer, Onyx Pharmaceuticals) for the treatment of hepatocellular carcinoma, or primary liver cancer.
Upon receipt of this milestone payment, which is expected shortly, Ardea will have received license fee and milestone payments under the agreement totaling $50 million. Ardea is eligible to receive up to an additional $357 million for achievement of future development and commercialization milestones, including $7.5 million for the initiation of a second Phase II clinical study of BAY 86-9766 for a different indication. Ardea will also be eligible to receive low double-digit royalties on worldwide sales of products under the license agreement.
“Based on the good tolerability and impressive number of patients who achieved stable disease or partial response to treatment in Phase I trials in refractory patients with advanced solid tumors, we believe BAY 86-9766 has the potential to be a clinically important drug in the treatment of patients across multiple tumor types,” comments Barry D. Quart, Pharm D., Ardea’s president and CEO. “Including this milestone payment, we ended 2010 with unaudited, pro-forma cash and short-term investments of approximately $95 million, which will primarily be used to fund the further development of RDEA594, our lead product candidate for the chronic management of hyperuricemia and gout.”
Ardea Biosciences is focused on the development of small-molecule therapeutics. In addition to BAY 86-9766, the company has a lead candidate, RDEA594, in Phase II clinical development for the chronic management of hyperuricemia and gout. Ardea’s next-generation URAT1 inhibitor program is currently in preclinical development.