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news.Bayer HealthCare has agreed to pay $15m milestone payment to Ardea Biosciences, in connection with the terms of a global license agreement signed between the companies in April 2009 for the development and commercialization of Ardea's mitogen-activated ERK kinase (MEK) inhibitor compounds for cancer and other indications.
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The milestone was triggered by the initiation of a Phase 2 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 receive license fee and milestone payments under the agreement totaling $50m.
Bayer will pay up to an additional amount of $357m to Ardea for achievement of future development and commercialization milestones.
Additionally, Bayer is also responsible to pay an amount of $7.5m for the initiation of a second Phase 2 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.
Ardea president and CEO Barry Quart said based on the good tolerability and impressive number of patients who achieved stable disease or partial response to treatment in Phase 1 trials in refractory patients with advanced solid tumors, they believe BAY 86-9766 has the potential to be a clinically important drug in the treatment of patients across multiple tumor types.