Under the terms of the agreement, Array will receive an upfront payment of $60 million and additional contingent payments for certain clinical and commercial milestones. Array is responsible for completing the Phase 1 trial for ARRY-403. Amgen is responsible for future clinical development and commercialization for ARRY-403 and any resulting back-up compounds, with Array having an option to co-promote in the United States. Array will receive double digit royalties on sales of ARRY-403. In addition, Amgen will fund an agreed upon number of full time Array employees as part of a two-year research collaboration intended to identify and advance second-generation glucokinase activators.
"Type 2 diabetes affects over 20 million Americans and its incidence is increasing at an alarming rate," said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president of Research and Development. "We are pleased to be collaborating with Array BioPharma in this arena, and are excited about the potential of this glucokinase activator. Type 2 diabetes has long been an important focus of research for Amgen, and the addition of ARRY-403 clearly strengthens our diabetes pipeline."
"The glucokinase activator ARRY-403 is a member of a new class of drugs targeting Type 2 diabetes, and we're delighted to partner with Amgen to develop and commercialize this novel therapy for diabetic patients," said Robert E. Conway, chief executive officer, Array BioPharma. "Amgen is a leading innovator of important new therapies, with a focus on the treatment of severe, chronic diseases, and we believe that this collaboration indicates the significant potential of our glucokinase activator program."
According to the Centers for Disease Control, approximately 24 million (8 percent) Americans have diabetes. Current therapies for this progressive disease are insufficient or have unwanted side-effects, creating a need for the development of novel therapeutic approaches.
About Glucokinase Activation
In normal individuals, the pancreas secretes insulin in response to increased levels of glucose in the blood. Glucokinase (GK) is the enzyme that senses glucose in the pancreas. GK also increases glucose utilization and decreases glucose production in the liver. In patients with Type 2 diabetes, there is a reduction of GK activity in the pancreas and the liver. Activating GK with small molecules such as ARRY-403 lowers blood glucose levels by enhancing the ability of the pancreas to sense glucose, which leads to increased insulin production. Simultaneously, glucokinase activators increase the net uptake of blood glucose by the liver. Glucokinase activators, such as ARRY-403, represent a promising new class of drugs for the treatment of Type 2 diabetes.
ARRY-403 is a potent, selective and orally administered small molecule glucokinase activator. In multiple preclinical models of Type 2 diabetes, ARRY-403 was studied in controlling both fasting and non-fasting blood glucose by itself and in combination with other existing standard-of-care diabetes drugs. In a Phase 1 single ascending dose study in patients with Type 2 diabetes, ARRY-403 demonstrated dose-dependent glucose reductions.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, inflammatory and metabolic diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas. For more information on Array, please go to www.arraybiopharma.com.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.