The company also provided an update on its Phase 3 LDL cholesterol (LDL-C) lowering clinical trials for ORION-11.
The Medicines Company (NASDAQ:MDCO) has announced its Q3 financial results for the quarter ended September 30, 2019.
As quoted in the press release:
Third-quarter highlights included successful completion of pivotal Phase 3 LDL cholesterol (LDL-C) lowering clinical trials for inclisiran with presentation of efficacy and safety data for ORION-11 at the European Society of Cardiology’s ESC Congress 2019 and announcement of topline results for ORION-9 and ORION-10. Each study met all primary and secondary endpoints, showing durable and potent efficacy with twice-yearly dosing of inclisiran and excellent safety with no treatment-related liver or renal laboratory abnormalities.
“Flawless execution defined our performance in the third quarter, as outstanding progress for our pivotal Phase 3 clinical trials moves us closer to our goal of realizing the intrinsic value of inclisiran,” said Mark Timney, Chief Executive Officer of The Medicines Company. “Clinical data confirm inclisiran’s highly differentiated profile and reinforce its potential to transform the treatment of cardiovascular disease for millions of patients with significant unmet needs.”
During the quarter, the company completed validation of manufacturing batches for inclisiran, enabling commercial scale manufacturing and also supporting anticipated regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.