medicines company (MDCO) Key Developments
The Medicines Company and SciClone Pharmaceuticals Establish Strategic Partnership for Two Cardiovascular Products in China
Dec 18 14
The Medicines Company and SciClone Pharmaceuticals announced the establishment of a strategic partnership for two cardiovascular products in China. The partnership includes an agreement granting SciClone a license and the exclusive rights in China to promote two products of The Medicines Company: ANGIOMAX (bivalirudin) for Injection, an anticoagulant indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. A Phase 3 registration trial was completed in China and is currently under review by the China Food and Drug Administration (CFDA) for marketing approval. CLEVIPREX (clevidipine) Injectable Emulsion, a third-generation dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or desirable. The clinical trial application (CTA) for China was filed in 2013. Under the terms of the agreement, SciClone will be responsible for all aspects of commercialization, including pre- and post-launch activities, for both products in the China market (excluding Hong Kong and Macau). SciClone has also agreed to assist in the China registration process for both products. Financial terms of the agreement, in addition to net sales royalties payable to The Medicines Company, include the following additional payments to The Medicines Company: an upfront payment; a product support services fee; and regulatory/commercial success milestone payments of up to an aggregate of $50.5 million.
The Medicines Company Presents at Oppenheimer 25th Annual Healthcare Conference, Dec-10-2014 09:10 AM
Dec 3 14
The Medicines Company Presents at Oppenheimer 25th Annual Healthcare Conference, Dec-10-2014 09:10 AM. Venue: The Crowne Plaza Hotel, New York, New York, United States. Speakers: Glenn P. Sblendorio, President, Chief Financial Officer, Treasurer and Director.
The Medicines Company Presents New Phase 1 Study of MDCO-216
Nov 16 14
The Medicines Company presented findings from a new Phase 1 study showing that a single infusion of MDCO-216, in both healthy and CAD patients, modified key lipid parameters including ApoA-1, phospholipids, HDL, pre-beta 1 HDL and Apo E, markedly increased ABCA1 mediated efflux, a potential marker of reverse cholesterol transport and was well tolerated. The study was presented as part of a poster session at The American Heart Association's Annual Scientific Sessions in Chicago. Clinical findings have shown that human carriers of the ApoA-1 Milano variant have a reduced incidence of cardiovascular disease. MDCO-216, currently under development by The Medicines Company, is a complex of recombinant human Apo A1 with phospholipids to emulate an HDL particle. MDCO-216 has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport, and its potential impact on reducing cardiovascular events in acute coronary syndrome (ACS) patients. In the Phase 1 study, 24 healthy volunteers and 24 patients with documented CAD received a 2-hour infusion of MDCO-216 in a randomized, placebo-controlled, single ascending dose study. Five cohorts of healthy volunteers and four cohorts of CAD patients received doses ranging from 5 - 40 mg/kg. Subjects were followed for 30 days and returned throughout the study for safety assessments. In both healthy volunteers and stable CAD patients, dose dependent increases in ApoA-1, phospholipid and prebeta-1 HDL and decreases in Apo E were observed. Prominent and sustained increases in triglyceride and decreases in HDL-C occurred at doses above 20 mg/kg in both healthy volunteers and patients with CAD. In both subject populations, profound increases in ABCA1 mediated cholesterol efflux were observed. Other lipid and lipoprotein parameters were generally unchanged with increases in HDL particle size and a shift to larger HDL particles. The study also demonstrated that MDCO-216 was well tolerated with no serious adverse events and no other significant adverse safety findings, including laboratory parameters.
The Medicines Company - Analyst/Investor Day
Oct 31 14
To provide a comprehensive overview of the company's business and strategies for growth at what promises to be a highly informative event
The Medicines Company Announces Results of Pivotal Phase III Clinical Trial of Investigational Hemostatic Agent RAPLIXA at Clinical Congress of the American College of Surgeons in San Francisco, Ca
Oct 28 14
The Medicines Company announced the presentation of the results of the pivotal Phase III clinical trial of the investigational hemostatic agent RAPLIXA (fibrin sealant), formerly known as Fibrocaps, at the 100(th) Clinical Congress of the American College of Surgeons in San Francisco, CA. As previously reported, the Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection. RAPLIXA, currently under regulatory review with the U.S. Food and Drug Administration and the European Medicines Agency, is a dry powder topical formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery. FINISH-3 is an international, randomized, single-blind, controlled trial that compared the efficacy and safety of RAPLIXA(TM), a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen with gelatin sponge, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in four indications (spinal, hepatic, vascular, soft tissue dissection). Adults with mild/moderate surgical bleeding -- randomized 2:1; RAPLIXA(TM) vs. gelatin sponge -- were treated at a single bleeding site (Day 1). Time to hemostasis (TTH) over five minutes was compared (log-rank statistic) within each indication. Safety follow-up continued to Day 29. Patients were treated (RAPLIXA(TM): 480; gelatin sponge: 239) while undergoing spinal (n=183), vascular (n=175), hepatic (n=180), or soft tissue (n=181) procedures. RAPLIXA(TM) was applied by spray device in 53% of all procedures (94% of hepatic and soft tissue procedures). RAPLIXA(TM) significantly reduced TTH compared to gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each p<0.001; primary endpoint). RAPLIXA(TM) significantly reduced median TTH for each indication (p<0.0001), and was superior for secondary efficacy endpoints of restricted mean TTH (p<0.0001) and probability of hemostasis at 3 (p<0.0001) and 5 (p<=0.002) minutes. Adverse event incidences were generally similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2% of RAPLIXA(TM)-treated and 3% of gelatin sponge-treated patients.