"Completion of enrollment in ORION-10 is one of the key milestones in our quest to confirm the promising safety and efficacy data for inclisiran, which were reported during Phase I and Phase II clinical studies," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "We believe that the rapid pace of enrollment in the pivotal trials of the ORION program, as well as the quality of data emerging from this and other trials, reflect the design of the studies, the effective operational support of excellent clinical sites, exceptional work by our team and our partners at PPD, and the apparent ease of use of the protocol and study medication," continued Dr. Meanwell.About ORION -10 ORION-10 is a Phase III, placebo-controlled, double-blind, randomized study of ~1,500 patients with ASCVD (coronary heart disease, cerebrovascular disease and peripheral arterial disease), and elevated LDL-C levels above 70 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 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 Company The 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 StatementsStatements in this presentation about The Medicines Company (the Company), the Company's products and product candidates, the timing of clinical trial results, regulatory submissions, product or indication launches, the Company's strategy, future financial results and operations, and future opportunities for the 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," "plans," "expects," "intends," "estimates," "potential," "outlook," "may," "will," "would," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward looking statements, including: whether the Company's product candidate will advance in the clinical trials process on a timely basis or at all; whether clinical trial results will warrant submission of applications for regulatory approval; whether the Company's product candidate will receive approvals from regulatory agencies; the extent of the commercial success of the Company's product candidate, if approved; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission (SEC) including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 1, 2018, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements whether as a result of new information, future events or otherwise.