The Medicines Company (MDCO - Analyst Report) announced positive top-line results from a Day 90 interim analysis of the ongoing ORION-1 phase II study of its pipeline candidate, PCSK9si, for the treatment of hypercholesterolemia.
PCSK9si, earlier known as ALN-PCSsc, is a first-in-class investigational proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis inhibitor that inhibits PCSK9 synthesis in the liver.
ORION-1 is a placebo-controlled, double-blind, randomized, dose-finding phase II study. It compares and evaluates the effect of various doses of single or multiple subcutaneous injections of PCSK9si. The study is being conducted in a total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (hypercholesterolemia).
The interim data demonstrated that PCSK9si led to a significant and durable reduction of LDL (low-density lipoprotein) cholesterol upto day 90. PCSK9si was well tolerated throughout the study, with infrequent and mild or moderate injection site reactions.
Further results from the ORION-1 study, including the Day 180 follow-up for up to 200 patients, are expected to be presented at an American Heart Association meeting scheduled for Nov 15, 2016.
The Medicines Company is developing PCSK9si under a collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Analyst Report) , which was inked in early 2013. The Medicines Company is responsible for the development and commercialization of the candidate.
The Medicines Company has several other pipeline candidates targeting key focus areas. Three of these candidates have blockbuster potential. These include MDCO-216 (atherosclerotic plaque burden), ABP-700 (general anesthesia for surgical care) and Carbavance (treatment of hospitalized patients with serious gram-negative bacterial infections).
Zacks Rank & Key Picks
The Medicines Company currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN - Analyst Report) and Exelixis, Inc. (EXEL - Analyst Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 100.9% year to date.
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