What happened
Shares of The Medicines Company (MDCO) closed the trading day up 12.8% following the presentation of two phase 3 clinical trials testing cholesterol-lowering drug inclisiran at the American Heart Association's Scientific Sessions in Philadelphia. Shares of Alnylam Pharmaceuticals (ALNY -0.28%), which discovered the RNAi-based drug and will receive royalties on sales, were essentially flat for the day.
So what
The Medicines Company had already announced that the Orion-9 and Orion-10 trials were successful, but the company held the data for the Philadelphia meeting.
In Orion-9, inclisiran reduced LDL cholesterol -- that's the bad kind -- by 50% relative to a placebo over the 18-month study. In days 90 through 540, the time-averaged placebo-adjusted reduction of LDL cholesterol was 45%.
The LDL cholesterol reductions for Orion-10 looked even better, with a placebo-adjusted 18-month reduction of 58% and a time-averaged placebo-adjusted reduction of 56% from days 90 through 540.
The results bookended those of the third phase 3 study, Orion-11, released in September, in which the drug produced a 54% reduction in LDL cholesterol with time-adjusted reductions of 50%.
Most importantly, there were no new safety issues that might trip up inclisiran's approval.
Image source: Getty Images.
Now what
The Medicines Company plans to submit marketing applications for inclisiran to the Food and Drug Administration before the end of the year and to European regulators in the first quarter of next year.
With data presented, The Medicines Company is less risky from a clinical standpoint, but much of the near-term upside has also been achieved. Biotech investors should keep in mind that the commercial launch might be more challenging, with inclisiran facing competition from established cholesterol-lowering drugs from Amgen (AMGN 0.22%), as well as Sanofi (SNY -0.47%) and Regeneron Pharmaceuticals (REGN -0.84%), which have the same target as inclisiran.
