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European Union's CHMP Adopts Positive Opinion for NOXAFIL(R) (Posaconazole) Oral Suspension for Treatment of Invasive Fungal Infections

Posted on: Thursday, 28 July 2005, 15:00 CDT

KENILWORTH, N.J., July 28 /PRNewswire/ -- Schering-Plough Corporation today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of NOXAFIL(R) (posaconazole) Oral Suspension for the treatment of certain serious invasive fungal infections in adult patients with refractory disease (failed prior therapy) or who are intolerant to other therapy.

The CHMP recommendation of NOXAFIL serves as the basis for a European Commission approval. A Commission Decision will result in Marketing Authorization with unified labeling that will be valid in the current EU 25 member states as well as in Iceland and Norway. Approval of NOXAFIL in the European Union would represent the first marketing approval for posaconazole, a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute. 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 either chemotherapy or stem cell transplant.

"I am pleased that the CHMP has granted a positive opinion for posaconazole in refractory invasive fungal infections. This will offer the medical community in Europe an oral therapy for severely ill patients who are struggling not only with their hematological malignancies but also with difficult fungal infections requiring long-term treatment," said Raoul Herbrecht, MD, professor and head of hematology in the Department of Hematology and Oncology, University Hospital of Strasbourg, France.

"A key challenge facing physicians in treating fungal infections today is finding effective treatment options when patients do not respond to or cannot tolerate initial therapy," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "NOXAFIL, upon approval, will provide a new therapeutic option for patients with serious infections caused by certain difficult-to-treat fungal organisms, including those refractory to other drugs."

Study Results

The CHMP positive opinion 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.

NOXAFIL Safety Information

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 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 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 exhibits potent antifungal activity in vitro against a wide range of fungal pathogens, including both yeasts and moulds. NOXAFIL, upon approval, would provide a new therapeutic option for serious infections caused by aspergillosis, fusariosis, chromoblastomycosis, mycetoma, and coccidioidomycosis. 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 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 the company's strategy and the potential regulatory approval for NOXAFIL. Forward- looking statements relate to expectations or forecasts of future events and use words such as "will" and "plans." Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering- Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough's forward-looking statements. These factors include uncertainties of the regulatory approval and review process and difficulties in product development. 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

CONTACT: Media - Mary-Frances Faraji, +1-908-298-7109, or Gail Thornton,+1-908-298-5313, Investors - Alex Kelly, +1-908-298-7436, all forSchering-Plough Corporation

Web site: http://www.schering-plough.com/

Company News On-Call: http://www.prnewswire.com/comp/777050.html

Source: PRNewswire

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