Tuesday July 6, 8:16 am Eastern Time
Company Press Release
SOURCE: Schering-Plough Corporation
Schering-Plough Announces EU
Approval of INTEGRILIN(R) for the
Prevention of Early Myocardial
Infarction in Patients Presenting with Unstable Angina or
Non-Q-Wave Myocardial Infarction
MADISON, N.J., July 6 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP - news)
announced today that the European Union's (EU) Commission of the European Communities has
granted marketing authorization to INTEGRILIN® (eptifibatide) Injection for the prevention of early
myocardial infarction in patients with unstable angina (UA) or non-Q-wave myocardial infarction
(NQMI), serious heart conditions known collectively as acute coronary syndromes (ACS), who are
managed medically and/or with percutaneous coronary intervention (PCI).
European Commission approval of the centralized Marketing Authorization Application for
INTEGRILIN results in a single marketing authorization with unified labeling that is immediately valid
in all 15 European Union-Member States. The approval follows a positive recommendation by the
European Agency for the Evaluation of Medicinal Products' (EMEA) Committee for Proprietary
Medicinal Products (CPMP) in February 1999.
Schering-Plough will launch and market INTEGRILIN in Europe. It is marketed in the United States
by COR Therapeutics, Inc. (Nasdaq: CORR - news) and Key Pharmaceuticals, a pharmaceutical
marketing unit of Schering-Plough.
INTEGRILIN is a member of a new class of drugs known as platelet receptor GP IIb-IIIa
inhibitors. A landmark global trial known as PURSUIT (Platelet IIb-IIIa in Unstable Angina:
Receptor Suppression Using INTEGRILIN Therapy) served as the basis for the marketing
application authorization. PURSUIT demonstrated that INTEGRILIN significantly reduces the
combined incidence of death or myocardial infarction (MI) in patients admitted to the hospital with
UA or NQMI. Results of PURSUIT were published in the August 13, 1998 issue of The New
England Journal of Medicine. The study found that INTEGRILIN was effective in reducing the
incidence of death or MI in the 30 days following an episode of UA or NQMI regardless of whether
the patient was receiving drug therapy alone or in combination with invasive cardiac procedures.
Bleeding is the most common complication encountered during INTEGRILIN therapy. The majority
of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal,
genitourinary, gastrointestinal and retroperitoneal bleeding were also seen more commonly with
INTEGRILIN compared to placebo. Contraindications include, but are not limited to, a history of
bleeding diathesis or stroke, evidence of abnormal bleeding within the previous 30 days, recent
major surgery, or concomitant use of a GP IIb-IIIa inhibitor.
''The evidence clearly suggests that the use of GP IIb-IIIa inhibitors should be considered a new
standard of care in the management of ACS,'' said Professor Maarten Simoons, Erasmus University
and University Hospital Dijkzigt in Rotterdam, the Netherlands, and principal European PURSUIT
investigator. ''With PURSUIT and other clinical studies of its kind confirming the benefit of this
therapeutic class, we have the opportunity to advance the treatment of patients suffering from acute
coronary syndromes.''
The cost-effectiveness of eptifibatide in treating cases of ACS compared to other cardiac
interventions in Western Europe was evaluated as part of a prospective substudy of PURSUIT. ''It
is the patient who ultimately reaps the benefits of this therapy,'' said Professor Karl Karsch,
University of Tubingen, Germany and the German country coordinator for PURSUIT.
Worldwide hospitalizations for UA and NQMI are estimated to be in excess of 2 million patients
annually. Approximately 1 million patients in Europe suffer from ACS. In the United States, ACS are
the leading cause of admission to coronary care units; approximately 10 to 12 percent of these
patients develop myocardial infarction and 2 to 5 percent die within 30 days of experiencing UA or
NQMI.
In the United States, INTEGRILIN received Food and Drug Administration (FDA) marketing
clearance in May 1998 for treatment of patients with ACS (UA/NQMI), including patients who are
to be managed medically and those undergoing percutaneous coronary intervention (PCI).
INTEGRILIN is also indicated in the United States for the treatment of patients undergoing PCI.
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