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The SOUL trial met its primary objective by demonstrating a 14% reduction in the risk of major adverse cardiovascular events (MACE), which include cardiovascular death, nonfatal heart attacks, and nonfatal strokes, for patients treated with Rybelsus compared to those receiving a placebo.
Peripheral artery disease is a serious type of atherosclerotic cardiovascular disease that is often underdiagnosed and affects about 230 million people worldwide.
Under the terms of the agreement, Lexicon will complete specific preclinical activities before handing over the reins to Novo Nordisk for further development, manufacturing, and commercialization.
In this agreement, United Biotechnology will receive an upfront payment of US$200 million, with potential milestone payments from Novo Nordisk that could reach up to US$1.8 billion.