SOURCE: The Medicines Company

The Medicines Company

August 28, 2012 14:36 ET

Le Ultime Linee Guida Europee Sull'Infarto Raccomandano L'Uso Dell' Angiomax®/Angiox® (Bivalirudina) Al Di Sopra Dell'Eparina

MONACO, GERMANIA--(Marketwire - Aug 28, 2012) - Le linee guida aggiornate sulla gestione dell' infarto severo ovvero infarto del miocardio acuto con sopraslivellamento del segmento ST (STEMI) presentate da un'esperta task force leader europea raccomandano l'uso della bivalirudina (The Medicines Company (NASDAQ: MDCO) nome commerciale Angiox® in Europa e Angiomax® nell'America del Nord e in Asia) al di sopra dell'eparina e degli inibitori delle GP IIb/ IIIa.

Secondo le linee guida, un anticoagulante "deve" essere usato nei pazienti sottoposti ad intervento coronarico percutaneo primario (PCI), una procedura d'emergenza salva vita utilizzata per riaprire le arterie coronarie e ripristinare il flusso sanguigno del muscolo cardiaco che subisce l'infarto. Gli esperti hanno individuato in Angiox la prima scelta di Classe I "raccomandata al di sopra al di sopra dell'eparina e degli inibitori delle GP IIb/ IIIa ."

Le linee guida, presentate durante il congresso annuale European Society of Cardiology (ESC) tenutosi a Monaco questa settimana, sono il risultato del lavoro di 23 membri esperti della Task Force on Myocardial Revascularization of the European Society of Cardiology. Le linee guida forniscono raccomandazioni per la gestione del paziente con infarto acuto dalla diagnosi al trattamento, e vengono utilizzate in ambito sanitario in tutta l'Europa.

Il gruppo di esperti ha riconosciuto bivalirudina come l'antitrombotico endovenoso avente la più elevata classe di raccomandazione e il più elevato livello di evidenza negli studi clinici (Classe I, livello di evidenza B) tra gli antitrombotici endovenosi considerati dalle linee guida aggiornate.

Efthymios Deliargyris, MD, Global Medical Director della The Medicines Company, ha commentato, "Negli ultimi anni sono stati fatti passi da gigante nella gestione dello STEMI. In confronto ad alcuni anni fa, e grazie ai progressi nelle tecniche del trattamento, delle tecnologie e dei farmaci disponibili per i pazienti STEMI, il rischio di morire si è sensibilmente ridotto.."

Cees Heiman, Senior Vice President e Regional Engagement Leader dell'Europa e del Medio Oriente per The Medicines Company ha affermato:, " Dall'ultimo aggiornamento delle linee guida nel 2010, si sono raggiunti importanti obiettivi per l'Angiox The Medicines Company in Europa. . Di rilevante importanza,, nel Giugno del 2011,, The Lancet ha pubblicato i risultati finali a tre anni dello studio clinico globale HORIZONS-AMI condotto su 3,602 pazienti STEMI sottoposti a PCI primaria. Noi accogliamo favorevolmente questo ultimo aggiornamento delle linee guida, poichè saranno di supporto in ambito sanitario per decidere consapevolmente il miglior trattamento per i propri pazienti.

About Angiox®
In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.

About Angiomax® (bivalirudin) for Injection
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life.

In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in ACS patients not undergoing PCI or PTCA. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "plans" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax, the Company's ability to develop its global operations and penetrate foreign markets, risks associated with the establishment of global operations, whether physicians, patients and other key decision-makers will accept clinical trial results, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, including for additional patient populations, whether the Company will be able to obtain regulatory approvals, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 9, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

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