Profile: Medicines Co (MDCO.O)
7 Mar 2014
The Medicines Company, incorporated on July 31, 1996, is a pharmaceutical company focused on the treatment of critical care patients through the delivery of medicines to the global hospital marketplace. The Company has three marketed products: Angiomax(bivalirudin), Cleviprex (clevidipine butyrate) injectable emulsion and its ready-to-use formulation of Argatroban. It also has a pipeline of acute and intensive care hospital products in development, including three late-stage development product candidates, cangrelor, oritavancin and MDCO-157, and two early stage development product candidates, MDCO-2010 and MDCO-216. All of its marketed products and products in development are administered intravenously. All of its acute care generic products are injectable products. In January 2012, the Company acquired from APP Pharmaceuticals, LLC (APP), non-exclusive rights to market in the United States a portfolio of ten generic drugs, which it refers to as its acute care generic products. In January 2013, the Company acquired Incline Therapeutics Inc. Effective August 5, 2013, The Medicines Company acquired the entire interest of ProFibrix BV, a biotechnology company. Effective December 4, 2013, The Medicines Co acquired Rempex Pharmaceuticals Inc.
The Company licensed Angiomax, an intravenous direct thrombin inhibitor, which is a peptide compound, from Biogen Idec, Inc. (Biogen Idec) and have license rights to develop, market, and sell Angiomax globally. It markets Angiomax in the United States for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and for use in patients undergoing percutaneous coronary intervention (PCI), including patients with or at risk of heparin induced thrombocytopenia and thrombosis syndrome (HIT/HITTS). In Europe, the Company markets Angiox for use as an anticoagulant in patients undergoing PCI, for use in adult patients with acute coronary syndrome (ACS), and for the treatment of segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. Its approval for ACS in Europe also includes patients with unstable angina or non-STEMI planned for urgent or early intervention when used with aspirin and clopidogrel. Angiomax is also approved for sale in Australia, Canada and a range of countries in Central America, South America and the Middle East for PCI indications similar to those approved by the Food and Drug Administration (FDA). In addition, Angiomax is approved in Canada for the treatment of patients with HIT/HITTS undergoing cardiac surgery.
The Company develops Angiomax for use in additional patient populations, including patients with structural heart disease, patients undergoing peripheral angioplasty, carotid angioplasty and cardiovascular surgery and patients with or at risk of HIT/HITTS. It markets Angiomax to hospital systems, individual hospitals and health care providers, including interventional cardiologists in cardiac catheterization laboratories.
As of December 31, 2011, the Company had operations in Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, India, Italy, the Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Switzerland and the United Kingdom and are developing its business infrastructure and capabilities in Brazil, China, Eastern Europe and Turkey. It has tested Angiomax against heparin or enoxaparin or combinations of drugs, including heparin or enoxaparin and glycoprotein IIb/IIIa receptor (GP IIb/IIIa) inhibitors or oral P2Y12 inhibitors in 12 comparative PCI and ACS trials. It develops Angiomax for use in additional patient populations, including patients with structural heart disease, patients undergoing peripheral angioplasty, carotid angioplasty and cardiovascular surgery and patients with or at risk of HIT/HITTS.
As of December 31, 2011, the Company was conducting a phase-IV clinical trial of Angiomax, which it refers to as the EUROMAX trial, to assess whether the early administration of Angiox in STEMI patients intended for PCI presenting either through the ambulance or to referral centers. During the year ended December 31, 2011, the Company supported a pilot study of the use of Angiomax in catheter-based procedures in patients with defective aortic heart valves in whom surgery is not possible. These procedures are either transcatheter aortic valve implantations (TAVI), where a valve is implanted using a percutaneous approach, or balloon aortic valvuloplasty procedures (BAV), where a balloon is used to repair the damaged aortic valve.
Cleviprex is an intravenous small molecule calcium channel blocker for the reduction of blood pressure when oral therapy is not feasible or not desirable. It has exclusive license rights to develop, market, and sell Cleviprex globally. In addition to the United States, Cleviprex is also approved for sale in the United Kingdom, the Netherlands, Australia, New Zealand, Sweden and Switzerland with indications for blood pressure control in perioperative settings. As of December 31, 2011, the Company did not sold Cleviprex outside the United States. In June 2011, the FDA approved an sNDA that it submitted for an improved formulation of Cleviprex. It re-launched Cleviprex in October 2011 with the new formulation for neurocritical care patients, including intracranial bleeding and acute ischemic stroke patients requiring blood pressure control, and cardiac surgery patients, including patients undergoing coronary artery bypass graft surgery, heart valve replacement or repair, and surgery for the repair of aortic dissection.
Cangrelor is an intravenous small molecule antiplatelet agent that the Company is developing to prevent platelet activation and aggregation, which leads to thrombosis in the acute care setting of the cardiac catheterization laboratory to address unmet medical needs in patients undergoing PCI. It has license rights to develop, market, and sell cangrelor globally, excluding Japan, China, Korea, Taiwan and Thailand. In patients undergoing PCI, the use of antiplatelet agents blocks platelet activation at the time of the PCI. Clopidogrel is marketed under the brand name Plavix by Bristol-Myers Squibb Co./Sanofi Pharmaceuticals Partnership. Clopidogrel is administered at a high dose by giving patients four to eight oral tablets at the time of PCI. This practice is known as pre-loading.
Oritavancin is an investigational intravenous antibiotic, which Company is developing for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). Oritavancin is synthetically modified from a naturally occurring compound. Oritavancin was originally discovered and developed by Eli Lilly to combat antibiotic-resistant Gram-positive pathogens, including MRSA and pathogens resistant to vancomycin, prescribed antibiotic for resistant Gram-positive infections. It has rights to develop, market, and sell oritavancin worldwide under a license agreement with Eli Lilly.
The Company’s SOLO I and SOLO II trials are identical multicenter, double-blind, randomized clinical studies, in which a single 1,200 milligrams intravenous dose of oritavancin is compared with seven to 10 days of intravenous vancomycin treatment. The Company is exploring the development of oritavancin for other indications, including for the treatment of Clostridium difficile, anthrax and other Gram-positive bacterial infections.
In May 2011, the Company entered into a licensing agreement with Ligand Pharmaceuticals Incorporated (Ligand), through its subsidiary CyDex Pharmaceuticals, Inc. Under the agreement, the Company acquired a global license to patents claiming a Captisol-enabled intravenous formulation of clopidogrel bisulfate, which it refers to as MDCO-157.
MDCO-2010 is a small molecule serine protease inhibitor, which it is developing as an intravenous antifibrinolytic for the reduction of blood loss during surgery. During 2011, the Company completed Phase 2a clinical trial conducted in Switzerland to study the safety, tolerability, pharmacokinetics and pharmacodynamics of MDCO-2010.
MDCO-216 is a naturally occurring variant of a protein found in human high-density lipoprotein (HDL), which has the potential to reverse atherosclerotic plaque development and reduce the risk of coronary events in patients with ACS. It licensed global rights to MDCO-216, from Pfizer Inc. (Pfizer).
Ready-to-Use Formulation Argatroban
The Company has licensed from Eagle Pharmaceuticals, Inc. (Eagle), marketing rights in the United States and Canada to a ready-to-use formulation of Argatroban developed by Eagle. Argatroban, which is marketed by GlaxoSmithKline in a concentrated formulation and by Sandoz, a Novartis company, in a ready-to-use formulation, is approved as an anticoagulant in the United States for prophylaxis or the treatment of thrombosis in patients with or at risk for HIT and for patients with or at risk for HIT undergoing PCI. In June 2011, the FDA approved ready-to-use Argatroban for prophylaxis or treatment of thrombosis in adult patients with HIT and for use as an anticoagulant in adult patients with or at risk for HIT undergoing PCI. In September 2011, it began selling ready-to-use Argatroban. In December 2011, Eagle conducted a voluntary recall of the product due to the presence of particulate matter in some vials.
Acute Care Generic Products
On January 22, 2012, the Company entered into a license and supply agreement with APP in connection with the settlement of its patent litigations with APP. Under the license and supply agreement, APP granted to the Company a non-exclusive license under APP's marketing authorizations and to sell 10 generic products to hospitals and integrated delivery networks in the United States. The generic products are adenosine, amiodarone, azithromycin, clindamycin, esmolol, haloperidol, ondansetron, midazolam, milrinone and rocuronium. These acute care generic products are used in the therapeutic areas, in which it focuses or plan to focuses, including cardiovascular, neurocritical care and infection.
The Company competes with Eli Lilly, Johnson & Johnson, Centocor, Inc., Schering-Plough Corporation, Iroko Pharmaceuticals, LLC, MediCure Inc., Bristol Meyers Squibb, Sanofi-Aventis, Daiichi Sankyo, AstraZeneca, Cubist Pharmaceuticals, Inc., Pfizer, Monarch Pharmaceuticals Inc., Theravance, Inc., stellas Pharma Inc., Forest, Dainippon Sumitomo, GlaxoSmithKline and Sandoz.
8 SYLVAN WAY
PARSIPPANY NJ 07054
Company Web Links
- FDA panel votes against approval of Medicines Co's blood clot preventer
- UPDATE 1-FDA panel votes against approval of Medicines Co's blood clot preventer
- FDA panel votes against approval of Medicines Co's blood clot preventer
- FDA staff offer mixed view of Medicines Co's blood clot drug
- UPDATE 1-FDA staff offer mixed view of Medicines Co's blood clot drug