Array BioPharma Reaches Multi-Million Dollar Milestone
Array BioPharma Inc. recently announced that an $8.5-million milestone was achieved in its collaboration with Amgen. Array entered into an agreement with Amgen in December 2009 for the worldwide development of the small-molecule glucokinase activator (GKA) program, including AMG 151. The milestone was achieved after Amgen reached a pre-defined patient enrollment level in a Phase IIa clinical trial.
The Phase IIa trial is a randomized, double-blind, placebo-controlled study of AMG 151 in combination with metformin in patients with type 2 diabetes. The primary endpoint is change in fasting plasma glucose levels from baseline to end of treatment. Amgen continues to advance the trial and seeks to enroll approximately 224 patients.
Under the agreement, Amgen paid an up-front fee of $60 million. Array is also entitled to receive up to approximately $658 million in additional aggregate milestone payments if all clinical and commercialization milestones specified in the agreement for AMG 151 and at least one backup compound are achieved. Array will also receive royalties on sales of any approved drugs developed under the agreement.
Glucokinase activators, such as AMG 151, represent a promising new class of drugs for the treatment of type 2 diabetes. Glucokinase is the enzyme that acts as a glucose sensor in the pancreas and liver. The activation of glucokinase lowers glucose levels by enhancing the ability of the pancreas to sense glucose, which leads to increased insulin production. Simultaneously, GKAs increase the net uptake of blood glucose by the liver. In multiple well-established preclinical models of type 2 diabetes, AMG 151 was highly efficacious in controlling both fasting and non-fasting blood glucose, with rapid onset of effect and maximal efficacy within 5 to 8 once-daily doses. In these studies, when combined with existing standard-of-care drugs (metformin, Januvia (sitagliptin) or Actos (pioglitazone), AMG 151 provided additional glucose control, which reached maximal efficacy after 5 to 7 days of once-daily dosing. AMG 151 did not increase body weight, plasma triglycerides, or total cholesterol, whether used as monotherapy or in combination with other diabetes drugs.
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 and inflammatory diseases. Array has four core proprietary clinical programs: ARRY-614 for myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded clinical programs including two MEK inhibitors in Phase II clinical trials: selumetinib with AstraZeneca and MEK162 with Novartis. For more information, visit www.arraybiopharma.com.
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