If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Single-Bolus Thrombolytic, Metalyse (Tenecteplace, TNK-T-PA) Available In Europe INGELHEIM, GERMANY -- March 12, 2001 -- Boehringer Ingelheim announced that it will introduce its new single-bolus thrombolytic agent Metalyse® (tenecteplace, TNK-t-PA) in Germany, The Netherlands, Sweden, Austria, Denmark and Finland within the next days. The European Commission had granted Marketing Authorisation for the sale of Metalyse in the EU on 23rd February 2001. Introduction to additional European and other countries will follow during 2001/2002 after completion of further administrative, regulatory and logistical activities. Metalyse is a co-development with Genentech, which launched the drug under the trade name "TNKase™" in mid-2000 after having received FDA approval. As the first thrombolytic that can be given within seconds in a single bolus dose, Metalyse offers physicians unprecedented speed and reliability in the treatment of heart attack. Coronary heart disease is the leading cause of mortality and is responsible for one in five deaths in the industrial world. Most of these deaths are attributable to acute myocardial infarction. Metalyse is the only thrombolytic ever having shown therapeutic equivalence to Actilyse (alteplase) in a direct large-scale comparative trial. Actilyse, also within a co-marketing agreement with Genentech, has been the reference standard for the past decade. More than a million patients all over the world have been treated with Actilyse since its market The new drug, Metalyse, has unique, bio-engineered features designed to provide improved administration convenience and safety benefits while preserving the efficacy standard of Actilyse. Furthermore, Metalyse is compatible with established, adjunctive heart attack therapies. Both Actilyse and Metalyse are plasminogen activators, which convert plasminogen to active plasmin. Plasmin is in turn able to degrade fibrin to soluble degradation products. Fibrin is a naturally occurring protein fibre in blood, which forms a mesh, netting together the blood clots. Thus, plasmin mediates dissolution of a blood clot. The tissue plasminogen activator (t-PA) occurs naturally in only minute amounts in the blood. Whenever a thrombus develops, the formation of fibrin stimulates the release of t-PA and causes thrombolysis. However, the t-PA produced naturally soon becomes insufficient to dissolve clots rapidly, if a larger thrombus develops. Genentech and Boehringer Ingelheim were thus seeking improvements to Mother Nature's process. The first step was the development of alteplase by using recombinant DNA techniques. In 1993 the publication of the landmark GUSTO-1 study established the superiority of alteplase over streptokinase with respect to mortality reduction. The GUSTO-1 angiographic substudy also established the paradigm of "time is muscle," i.e. earlier re-vascularisation of the infarct-related artery results in a better clinical outcome. In a new approach Genentech and Boehringer Ingelheim had been looking for further improvements of thrombolytics which included the achievement of variants of t-PA with: -- a longer half-life and greater resistance to plasmin activator inhibitor PAI-1, which leads to a slower clearance for single bolus administration, These would improve the convenience of the treatment and make the drug far better suited for early administration in the emergency room, or even the ambulance, and further reduce the "time-to-needle" which would in turn be beneficial to the patient as "time is muscle." Metalyse embraces all these features. The ASSENT-2 clinical study with 17,000 patients demonstrated in 1999 that Metalyse and Actilyse have essentially identical rates of mortality, intracranial hemorrhage and total stroke. The mortality rates in this study were at 6.2 percent the lowest ever observed in a thrombolytic mega-trial, also reconfirming the low mortality data of GUSTO-1 for Actilyse. Furthermore, as Prof. Frans van de Werf, the chairman of ASSENT-2 explained, significantly fewer non-intracranial bleeding complications occurred in patients treated with Metalyse as compared to those receiving Actilyse. The most significant clinical adverse events observed in clinical trials with Metalyse included intracranial hemorrhage and total strokes, which are similar to those seen with other thrombolytics. As Dr Andreas Barner, Member of the Board of Managing Directors, responsible for Pharma Research, Development & Medicine points out, Metalyse is the cornerstone medication in four ongoing clinical studies, involving nearly 9,000 patients, that are seeking the best possible heart attack therapy regimen. The largest of these studies is ASSENT-3, a 6,000 patient, multi-centre trial that will evaluate the safety and efficacy of three different regimens of Metalyse and concurrent anti-thrombotic therapies, including the low molecular weight heparin enoxaparin sodium and the fibrinogen receptor antagonist abciximab. A satellite study, ASSENT-3 Plus, will enroll 1,000 heart attack patients treated prior to arriving in the emergency room or cardiology unit, e.g. in the pre-hospital setting. Related Link: Boehringer Ingelheim.
|
