In addition to the layoffs, the company is also looking to divest its Infectious Disease Business.
The Medicines Company released its third-quarter financial results today, with a focus on trying to divest its Infectious Disease Business, restructuring, and reducing headcount to less than 60 people.
Another key focus was on advancing the company’s Phase III clinical program for inclisiran for lowering LDL-C cholesterol. On Aug. 28, the company presented one-year data from the ORION-1 Phase II trial of the drug at the European Society of Cardiology (ESCO) Congress 2017. The drug showed significant success in lowering LDL-C with a starting dose of 300 mg on Day-1 and Day-90, showing a mean decrease of LDL-C of 56 percent at Day-150 and 51 percent at Day-180.
Also, on Aug. 29, the U.S. Food and Drug Administration (FDA) approved the company’s Vabomere (meropenem-vaborbactam) injection for adults with complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterbacter cloacae species complex.
“We made significant clinical and strategic progress during the third quarter,” said Clive Meanwell, The Medicines Company’s chief executive officer, in a statement. “We aggressively advanced start-up work for the inclisiran Phase III clinical program, preparing investigational sites—which began screening patients in September—and manufacturing double-blind-packaged drug supply, and are pleased to announce that dosing of patients in the Phase III LDL-C lowering program will commence next week. We remain confident that all trials comprising the inclisiran LDL-C lowering program will commence before year-end.”
The Medicines Company reported worldwide net revenues of $16.9 million for the third quarter, down significantly from $37.6 million in the third quarter of 2016. In the first quarter of 2016, the company finished divesting its hemostasis products for $174.1 million, as well as potential milestone payments up to another $235.0 million. Net income from discontinued operations in the third quarter of 2016 was $0.1 million.
For the nine months of 2017, net revenue was $59.8 million, compared to $142.6 million in the first nine months of 2016.
In terms of divesting its Infectious Disease Business, The Medicines Company hopes to make an announcement before the end of this year. Meanwell stated, “Independent of that transaction, we are finalizing plans to significantly restructure the remainder of The Medicines Company. We anticipate that the restructuring, which we intend to substantially implement within the next 45 days, will reduce headcount to less than 60 people at The Medicines Company (excluding the ID Business), significantly reducing go-forward annual operating expenses.”
The goal is, with the restructuring and the divestiture of the ID Business, that it will have enough money to aggressively move forward with its inclisiran development program. It expects a final readout from the Phase III LDL-C trial in the second half of 2019.
Inclisiran is a GalNAc-conjugated RNAi therapeutic that targets PCSK9. The company points out that, “In contrast to anti-PCSK9 monoclonal antibodies (MAbs) that bind to PCSK9 in blood, inclisiran is a first-in-class investigational medicine that acts by turning off PCSK9 synthesis in the liver.” The compound is being developed in collaboration with Alnylam Pharmaceuticals. This differentiates inclisiran from Amgen’s Repatha and Regeneron Pharmaceuticals’ and Sanofi’s Praluent.
