About ORION-9ORION-9 is a Phase III, placebo-controlled, double-blind, randomized study of ~400 heterozygous familial hypercholesterolemia patients with elevated LDL-C levels above 100 mg/dL despite maximum tolerated doses of LDL-C lowering therapies including statins. The primary endpoint of the study is LDL-C reduction from baseline to day 510. The trial also evaluates the safety and tolerability of inclisiran. About heterozygous familial hypercholesterolemia According to the Familial Hypercholesterolemia Foundation, familial hypercholesterolemia (FH) is an inherited disorder that leads to aggressive and premature cardiovascular disease. This includes problems like heart attacks, strokes, and even narrowing of heart valves. For individuals with FH, although diet and lifestyle are important, they are not the cause of high LDL. In FH patients, genetic mutations make the liver incapable of metabolizing (or removing) excess LDL. The result is very high LDL levels which can lead to premature cardiovascular disease (CVD). Heterozygous FH occurs in 1 in 250 people worldwide. In the United States alone, an estimated 1.3 million people live with FH. Yet only 10% of them are diagnosed. FH runs in families. If one parent has FH, each child has a 50% chance of having FH. If left untreated, men have a 50% rise of having a heart attack by age 50. Untreated women have a 30% risk by age 60. 1 in 160,000 to 1 in 1 million people have HoFH. For more information go to https://thefhfoundation.org About inclisiran Inclisiran is an investigational GalNAc-conjugated RNA interference therapeutic which inhibits the synthesis of PCSK9 protein in liver cells, thereby reducing liver cell LDL-receptor turnover, and lowering plasma LDL-C. The Medicines Company and Alnylam Pharmaceuticals, Inc. are collaborating in the advancement of inclisiran pursuant to the terms of their 2013 agreement. Under the terms of that agreement, Alnylam completed certain pre-clinical studies and the Phase I clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase II forward, as well as potential commercialization.
About The Medicines CompanyThe Medicines Company is a biopharmaceutical company driven by an overriding purpose - to save lives, alleviate suffering and contribute to the economics of healthcare. The Company's goal is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers in cardiovascular care. The Company is headquartered in Parsippany, New Jersey. Forward-Looking Statements Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" "expects" and "potential" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether clinical trials for inclisiran will advance on a timely basis, or at all, or succeed in achieving their specified endpoints; whether physicians will prescribe and patients will use inclisiran, if it becomes available; whether the Company will make additional regulatory submissions for inclisiran on a timely basis, or at all; whether the Company's regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all; and such other factors as are set forth in the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2017, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.