KENILWORTH, N.J., April 19 /PRNewswire-FirstCall/ -- Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational oral thrombin receptor antagonist (SCH 530348), currently in Phase II clinical development for secondary prevention of cardiovascular morbidity and mortality outcomes in at-risk patients.
The FDA granted Fast Track designation for the following reasons:
-- Cardiovascular disease, as evidenced in patients with acute coronary syndrome or in patients with a history of major cardiovascular disease, is a serious, life-threatening disease;
-- A drug to reduce cardiovascular morbidity and mortality addresses an unmet medical need.
Fast Track designation allows FDA to expedite review of drugs and biologics for serious or life-threatening conditions which demonstrate the potential to address unmet medical needs. An important feature of Fast Track designation is that it emphasizes the critical nature of close, early communication between the FDA and the sponsor company to improve the efficiency of product development.
Status of SCH 530348 Clinical Development
Schering-Plough is investigating SCH 530348 for prevention of arterial thrombosis in patients with acute coronary syndrome and those with prior myocardial infarction or stroke, as well as in patients with existing peripheral arterial disease.
Thrombosis may result in partial or complete blockage of critical arteries. This process is the underlying mechanism of most acute vascular events, including acute coronary syndromes (ACS) such as myocardial infarction (MI), and ischemic stroke, which are the leading causes of death. Platelets activated at the site of injured blood vessel walls release substances that initiate aggregation and clot formation. Drugs that block platelet activation by other mechanisms, such as the thromboxane or ADP mediated pathways, have shown reduction in such clinical events, but events continue to occur despite these therapies. There is, thus, a need for novel agents that specifically modify the actions of thrombin, the most potent activator of platelets. SCH 530348 binds selectively to the thrombin receptor on platelets (PAR-1), and is therefore a member of a potentially new class of drugs called thrombin receptor antagonists (TRA). Importantly, SCH 530348 is being investigated to determine whether it has the potential to provide clinical benefit through inhibition of this thrombin mediated platelet activation without the liability of increased bleeding, a tendency associated with drugs that block thromboxane or ADP pathways. SCH 530348 is being investigated as an oral antiplatelet agent for patients with established vascular disease. Results of a Phase I
clinical study with SCH 530348 were presented at the American Heart Association Scientific Sessions in Dallas, Texas, in November 2005.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to SCH 530348. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including risk factors listed in the company’s 2005 10-K.
Source: Schering-Plough Corporation
