KENILWORTH, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the European Commission has granted marketing approval to NOXAFIL(R) (posaconazole) Oral Suspension for the treatment of certain serious invasive fungal infections in adult patients with disease that is refractory to or who are intolerant of certain commonly used antifungal agents. The approval follows a positive opinion granted on July 27, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
In clinical studies, NOXAFIL has demonstrated broad-spectrum activity covering both yeasts and moulds responsible for serious invasive fungal infections. Invasive fungal infections, which can be life threatening, most often occur in people who are immunocompromised or immunosuppressed, such as organ transplant patients or cancer patients undergoing chemotherapy or stem cell transplant.
“With the approval of NOXAFIL, the European medical community now has a safe and effective option for treating patients with serious infections caused by a variety of fungal organisms, including those resistant to other therapies,” said Raoul Herbrecht, M.D., professor and head of hematology in the Department of Hematology and Oncology, University Hospital of Strasbourg, France. “NOXAFIL provides the coverage needed to effectively treat difficult fungal infections requiring long-term therapy.”
Approval of NOXAFIL in the European Union represents the first marketing approval for this novel antifungal agent discovered and developed by Schering- Plough Research Institute. The European Commission Decision results in Marketing Authorization with unified labeling that will be valid in the current 25 EU member states as well as in Iceland and Norway.
NOXAFIL is indicated for use in treating invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma and coccidioidomycosis in adult patients with refractory disease or who are intolerant of certain commonly used antifungal agents.
Clinical Study Results
The EU approval is based primarily on data from a clinical study evaluating NOXAFIL Oral Suspension 400 mg twice daily for the treatment of invasive aspergillosis in patients with refractory disease or who were intolerant of other medicinal products. In this study, a successful response (complete or partial resolution) at the end of treatment was seen in 42 percent (45 out of 107) of patients treated with NOXAFIL compared to 26 percent (22 out of 86) of patients in an external control group, as determined by an independent data review committee. The external control group was derived by retrospective review of medical records for patients with similar diagnoses treated within the same timeframe as those in the NOXAFIL cohort.
Additional clinical data from this study demonstrated that patients with invasive fungal infections caused by Fusarium, agents of chromoblastomycosis and mycetoma, and Coccidioides were successfully treated with NOXAFIL.
Clinical studies have demonstrated that NOXAFIL Oral Suspension is generally safe and well tolerated. The most frequently reported adverse reactions reported in healthy volunteers and patients receiving NOXAFIL were headache (8 percent) and nausea (6 percent). Treatment-related serious adverse events reported in patients with invasive fungal infections (1 percent each) included altered concentration of other medicinal products, increased hepatic enzymes, nausea, rash and vomiting. NOXAFIL co-administration with ergot alkaloids, CYP3A4 substrates known to prolong the QTc interval and HMG-CoA reductase inhibitors is contraindicated. NOXAFIL also should be used with caution in patients with pro-arrhythmic conditions and severe hepatic impairment. The safety and efficacy of NOXAFIL in patients below the age of 18 years have not been established.
About NOXAFIL
NOXAFIL (posaconazole) Oral Suspension is a novel triazole agent that exhibits potent antifungal activity in vitro against a wide range of fungal pathogens, including both yeasts and moulds. It has been studied as treatment for serious invasive fungal infections in patients with refractory disease. Development of NOXAFIL is consistent with Schering-Plough’s strategy to broaden its anti-infectives portfolio and is in line with its plans to build strength in its global franchises through both internal research and external licensing opportunities.
Schering-Plough Corporation 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 30,000 people around the world. The company’s Web site is 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 NOXAFIL and the company’s strategy. 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 the company’s second quarter 2005 10-Q.
Schering-Plough Corporation
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