On December 20, 2022 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported a $25M milestone payment from Amgen (NASDAQ: AMGN) (Press release, Arrowhead Pharmaceuticals, DEC 20, 2022, View Source [SID1234625459]). This milestone was triggered by the first subject enrolled in Amgen’s Phase 3 trial of olpasiran. Arrowhead is further eligible to receive up to an additional $535 million in aggregate development, regulatory, and sales milestone payments from Amgen and Royalty Pharma plc (NASDAQ: RPRX).
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"We are pleased with the great progress on the clinical development of olpasiran, which was developed using Arrowhead’s proprietary TRiMTM technology," said Christopher Anzalone, Ph.D., Arrowhead’s president and CEO. "This is an important milestone for the program and for Arrowhead, as this is the second TRiMTM-enabled candidate to enter Phase 3 studies. Importantly, as our pipeline continues to advance expeditiously, we anticipate multiple Arrowhead therapies will also reach Phase 3 trials over the coming year."
Olpasiran is a small interfering RNA (siRNA) originally developed by Arrowhead using its proprietary Targeted RNAi Molecule, or TRiM, platform and licensed to Amgen in 2016. It is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically determined risk factor for cardiovascular disease. Phase 2 study results from the OCEAN(a)-DOSE study were presented at the American Heart Association Scientific Sessions 2022, where olpasiran demonstrated a significant and sustained reduction in Lp(a) levels over 36 weeks. These data were simultaneously published in the New England Journal of Medicine on November 6, 2022.
About Lp(a)
Lp(a) is genetically determined1-3 and a presumed independent risk factor for cardiovascular disease (CVD). Although an agreed upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).1 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.