SAN DIEGO—Ardea Biosciences Inc. has earned a $15 million milestone payment from Bayer HealthCare AG (Bayer) 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.
The trigger for this particular milestone payment comes from the start of a Phase II clinical study evaluating MEK inhibitor BAY 86-9766 in combination with sorafenib (Nexavar from Bayer and Onyx Pharmaceuticals) for the treatment of hepatocellular carcinoma, or primary liver cancer.
In November 2010, Ardea had presented positive data from preclinical and clinical trials of BAY 86-9766 (formerly known as RDEA119) that complements this new study.
"Based on the good tolerability and impressive number of patients who achieved stable disease in this Phase I monotherapy trial 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," said Dr. Alex Adjei, one of the study investigators, at the time. "These monotherapy results support our ongoing Phase I/II study of BAY 86-9766 in combination with sorafenib at the maximum tolerated dose defined in this trial and the continued research by Bayer Healthcare on this important new targeted therapy."
This January 2011 milestone payment will bring to $50 million the total license fee and milestone payments that Bayer has paid under the agreement, but Ardea remains eligible to receive as much as $357 million more 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.
"We are extremely pleased to have reached this important clinical milestone in the development of BAY 86-9766," says Dr. Barry D. Quart, 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."
The trigger for this particular milestone payment comes from the start of a Phase II clinical study evaluating MEK inhibitor BAY 86-9766 in combination with sorafenib (Nexavar from Bayer and Onyx Pharmaceuticals) for the treatment of hepatocellular carcinoma, or primary liver cancer.
In November 2010, Ardea had presented positive data from preclinical and clinical trials of BAY 86-9766 (formerly known as RDEA119) that complements this new study.
"Based on the good tolerability and impressive number of patients who achieved stable disease in this Phase I monotherapy trial 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," said Dr. Alex Adjei, one of the study investigators, at the time. "These monotherapy results support our ongoing Phase I/II study of BAY 86-9766 in combination with sorafenib at the maximum tolerated dose defined in this trial and the continued research by Bayer Healthcare on this important new targeted therapy."
This January 2011 milestone payment will bring to $50 million the total license fee and milestone payments that Bayer has paid under the agreement, but Ardea remains eligible to receive as much as $357 million more 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.
"We are extremely pleased to have reached this important clinical milestone in the development of BAY 86-9766," says Dr. Barry D. Quart, 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."
