The Medicines Company Presents Clinical Data Analyses for Inclisiran at 87th European Atherosclerosis Society Congress

The Medicines Company (NASDAQ: MDCO) today announced presentation of analyses of two clinical studies of inclisiran at the 87^th European Atherosclerosis Society (EAS) Congress in Maastricht, Netherlands. A combined analysis (N=279) from the Phase 2 ORION-1 and Phase 1 ORION-7 trials, presented during an e-poster session, demonstrated that patients across a range of renal function levels achieved consistent reductions in low-density lipoprotein cholesterol (LDL-C) with no dose adjustment necessary for patients with renal impairment. Results from the Phase 2 ORION-2 pilot study, presented as a late-breaking abstract, showed that inclisiran provided durable reductions in LDL-C levels up to day 180 in patients with homozygous familial hypercholesterolemia (HoFH), a genetic disorder characterized by very high levels of LDL-C and early onset of cardiovascular disease, without the need to increase the dose of inclisiran.

“The information discussed at EAS supports inclisiran’s potential to address the high burden of cardiovascular disease caused by cumulative exposure to elevated LDL-C,” said Peter Wijngaard, Ph.D., Chief Development Officer of The Medicines Company. “We are pleased with these findings that demonstrate inclisiran’s potent, durable and consistent lowering of LDL-C, as well as favorable tolerability and safety, in patients with renal insufficiency or HoFH.”

Inclisiran, the first cholesterol-lowering therapy in the siRNA class, is The Medicines Company’s investigational therapy in Phase 3 clinical development to evaluate its ability to lower LDL-C through twice-a-year dosing. The company expects pivotal Phase 3 data readouts for inclisiran in the third quarter of 2019 followed by anticipated regulatory filings in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.

“There remains significant unmet need in the treatment of ASCVD, as approximately four out of five statin-treated patients are not at LDL-C goals, with poor adherence to therapy a major underlying cause,” said Mark Timney, Chief Executive Officer of The Medicines Company. “We are excited at the prospect of bringing forward a revolutionary approach to treat cardiovascular disease using a twice-a-year therapy with unique potential to address the need for additional LDL-C lowering and long-standing medication adherence challenges faced by millions of people.”