The Medicines Company (MDCO - Free Report) announced that its PCSK9 inhibitor candidate, inclisiran, met primary as well as secondary endpoints in two pivotal phase III studies — ORION-9 and ORION-10 — evaluating it in heterozygous familial hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD), respectively.
In the studies, inclisiran demonstrated durable and potent efficacy. Safety data from these studies showed that no treatment-related liver or renal laboratory abnormalities were observed.
Detailed data from these studies will be presented at the American Heart Association Scientific Sessions in Philadelphia scheduled to be held in November.
The completion of ORION-9 and ORION-10 studies along with recently completed ORION-11 study marks successful conclusion of pivotal stage LDL-C (bad cholesterol) lowering studies of inclisiran. Data from these studies will form the basis of regulatory submission for approval of inclisiran, which is expected in the United States in the fourth quarter of 2019 and in Europe in the first quarter of 2020.
In response to the positive development, shares of the company gained 5.5% on Sep 25. The company’s shares have surged 159.9% so far this year against the industry’s decline of 3.2%.
The Medicines Company is currently enrolling patients who have completed any of three phase III studies in the ORION program in open-label, long-term extension study — ORION-8.
Please note that The Medicines Company is developing inclisiran in partnership with Alnylam Pharmaceuticals (ALNY - Free Report) .
Meanwhile, the company presented detailed data from the ORION-11 study at the European Society of Cardiology’s ESC Congress 2019 earlier this month. Data showed that twice a year administration of inclisiran achieved a placebo-adjusted 54% reduction in LDL-C levels at day 510 in patients with ASCVD or ASCVD-risk equivalents and elevated LDL-C, following treatment with maximum tolerated dose of statin therapy alone or in combination with Merck’s (MRK - Free Report) Zetia. Moreover, time-adjusted reduction in LDL-C levels following treatment with inclisiran was 50%, which was sustained over 18 months of treatment.
We note that there are already two approved PCSK9 inhibitors — Sanofi/Regeneron’s Praluent and Amgen’s (AMGN - Free Report) Repatha — for treating hypercholesterolemia. However, accessibility of these drugs is hampered by high co-pay expenses and payer restrictions. This led to 60% reduction in list prices of Repatha and Praluent in the United States last year.
Although less frequent dosing of inclisiran compared to Repatha and Praluent may prove advantageous for the candidate following its potential approval, it is also likely to face challenges like high co-pay expenses and payer restrictions during commercialization.
The Medicines Company currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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