Healthcare Industry News:  myelodysplastic syndromes 

Biopharmaceuticals Regulatory

 News Release - September 22, 2006

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

Treatment of Oropharyngeal Candidiasis (OPC) Also Recommended for Approval

KENILWORTH, N.J., Sept. 22 (HSMN NewsFeed) -- Schering-Plough Corporation (NYSE: SGP ) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of NOXAFILŽ (posaconazole) Oral Suspension for prophylaxis (prevention) of invasive fungal infections (IFIs) in the following patients at high risk of developing these infections: patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD).

The CHMP also recommended approval of NOXAFIL for oropharyngeal candidiasis (OPC) as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. OPC is a fungal infection of the mouth and throat.

NOXAFIL currently is approved in the European Union (EU) and Australia for the treatment of certain IFIs in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents. Upon approval, the prophylaxis and OPC indications will expand the potential spectrum of use for NOXAFIL in the EU.

"This CHMP recommendation demonstrates how prophylaxis with NOXAFIL has the potential to change medical practice in this area, offering physicians a well tolerated, effective option for preventing serious invasive fungal infections," said Oliver Cornely, M.D., University of Cologne, Germany. "Invasive fungal infections are a leading cause of death in certain high-risk patient populations, so preventing these infections in the first place is critically important for these seriously ill patients."

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.

NOXAFIL Clinical Studies

The CHMP recommendation of NOXAFIL for prophylaxis is based primarily on the results of two successful head-to-head randomized clinical studies, the largest prophylaxis studies to date conducted in these high-risk patient populations. A total of more than 1,200 patients were enrolled in these studies. An open-label study compared NOXAFIL Oral Suspension 200 mg three times daily (n=304) to fluconazole suspension 400 mg once daily (n=240) or itraconazole oral solution 200 mg twice daily (n=58) as prophylaxis against IFIs in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS). A double-blind study compared NOXAFIL Oral Suspension 200 mg three times a day (n=301) to fluconazole capsules 400 mg once daily (n=299) as prophylaxis against IFIs in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease.

The CHMP recommendation of NOXAFIL for the treatment of OPC is based primarily on the results of a randomized, evaluator-blinded, controlled clinical study conducted in HIV-infected patients with azole-susceptible oropharyngeal candidiasis. This study compared NOXAFIL Oral Suspension (n=169) to fluconazole oral suspension (n=160), both given as 100 mg twice daily for one day followed by 100 mg once daily for 13 days.

NOXAFIL Safety Information

Clinical studies have demonstrated that NOXAFIL Oral Suspension is well tolerated. The most common treatment-related serious adverse events (1 percent each) in the combined prophylaxis studies were bilirubinemia, increased hepatic enzymes, hepatocellular damage, nausea and vomiting. In clinical trials, there were infrequent cases of hepatic reactions (e.g., mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical hepatitis).

Liver function tests (LFTs) should be monitored at the start of and during the course of therapy. Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine is contraindicated since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes. Co-administration with ergot alkaloids is also contraindicated.

Dose reduction and more frequent clinical monitoring of cyclosporine, tacrolimus and sirolimus should be performed when NOXAFIL therapy is initiated. In the EU, NOXAFIL is recommended for use in patients 18 years of age and above.

About NOXAFIL

NOXAFIL is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute. The U.S. Food and Drug Administration (FDA) on Sept. 15, 2006 approved NOXAFIL for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy. A new drug application for NOXAFIL for treatment of certain refractory IFIs received an approvable letter from FDA in June 2005 and is pending review of additional data. Schering-Plough also is seeking U.S. marketing approval of NOXAFIL for the treatment of oropharyngeal candidiasis (OPC) and this indication is currently undergoing FDA review.

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 related to NOXAFIL, its potential 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, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, 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 Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.


Source: Schering-Plough

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