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Angiomax

The Medicines Company

Drug Names(s): bivalirudin, Hirulog, Angiox

Description: Angiomax is a direct thrombin inhibitor that reduces the incidence of death, myocardial infarction, and requirements for revascularization in patients undergoing balloon angioplasty. Angiomax’s associated bleeding complication rate is less than other direct thrombin inhibitors and unfractionated heparin, and its treatment benefit profile has held up even for high-risk patient groups. It is indicated, with aspirin, for the anticoagulation of patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

Angiomax is a bivalent direct thrombin inhibitor, meaning that it binds to thrombin at two sites – a substrate recognition site and the enzymatic active site. The low molecular weight and other univalent inhibitors bind only to thrombin’s active site. Other bivalent thrombin inhibitors include recombinant hirudin, originally isolated from the salivary glands of the medicinal leech Hirudo medicinalis, now marketed by Aventis as Refludan [lepirudin]. Angiomax is an engineered analog of hirudin.

Refludan and Angiomax have demonstrated important clinical advantages over univalent direct thrombin inhibitors (Encysive’s Novastan [argatroban], efegatran, and AstraZeneca’s inogatran) in the management of acute coronary syndromes (myocardial infarction / heart attack; unstable angina; sudden cardiac death). Both bivalent and univalent direct thrombin inhibitors demonstrated important clinical advantages over the indirect thrombin inhibitor of choice in these clinical management scenarios – unfractionated heparin.

Direct thrombin inhibitors have been especially indicated for use in the management of patients with heparin-induced thrombocytopenia who require anticoagulation. Univalent direct thrombin inhibitors are sometimes used off-label in the setting of percutaneous coronary interventions (PCIs), but are thought to be less effective than Refludan and especially Angiomax in this setting.

Angiomax is used off-label for peripheral arterial disease interventional procedures.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

Nycomed Danmark A/S markets Angiomax in 35 countries including most of the E.U. CSL Limited markets Angiomax in Australia. Grupo Ferrer Internacional sells Angiomax in Spain, Portugal, Greece and eighteen Latin American markets including Argentina, Brazil and Mexico. Medison Pharma Ltd. sells Angiomax in Israel.

In July 2007, the Medicines Company announced that it had reacquired all development, commercial and distribution rights for Angiox in Europe from Nycomed.

Angiomax was originally developed by Biogen (now part of BiogenIDEC), which receives royalties on Angiomax sales.

In October 2011, The Medicines Company and Daiichi Sankyo announced a co-promotion for Angiox (bivalirudin) in Germany, beginning on November 1, 2011. No further details were disclosed.

In April 2012, AstraZeneca entered into a global collaboration agreement with The Medicines Company for their acute ischaemic...See full deal structure in Biomedtracker

Partners: Biogen, Inc. Daiichi Sankyo Co., Ltd. AstraZeneca PLC SciClone Pharmaceuticals, Inc.


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