SPRIAFIL(R) (posaconazole) is approved by Health Canada for prevention and treatment of invasive fungal infections



    Only antifungal product approved to prevent potentially life-threatening
    Aspergillus and Candida infections among high-risk patients

    MONTREAL, Nov. 12 /CNW/ - Canadian patients who are at high risk of
developing serious, and potentially life-threatening fungal infections now
have a new treatment option to prevent these infections from occurring and
treat them if they occur. SPRIAFIL(R) (posaconazole) Oral Suspension, a new
antifungal agent, has been approved by Health Canada, in patients 13 years of
age and older, for prophylaxis (prevention) of Aspergillus and Candida
infections in patients who are at high risk of developing these infections and
in the treatment of invasive aspergillosis in patients with disease that is
refractory to amphotericin B or itraconazole, or in patients who are
intolerant of these medicinal products.(1)
    Research has shown that patients undergoing allogeneic hematopoietic stem
cell transplant or chemotherapy for acute myelogenous leukemia or
myelodysplastic syndromes who develop IFIs have a high mortality rate of 50-90
percent.(2) Invasive fungal infections (IFIs) are considered extremely
difficult to assess which is why preventative measures are so important.(3)
Invasive fungal infections occur most often in people whose immune systems
have been compromised or weakened as a result of undergoing chemotherapy
treatment for leukemia, allogeneic stem-cell or bone marrow transplants for
example, and are a leading cause of death in this already high-risk group.
    "In patients with a compromised immune system, invasive fungal infections
can be quite serious and difficult to treat when they've become established",
said Dr. Jeffrey Lipton, Head, Chronic Myeloid Leukemia Group Princess
Margaret Hospital, Associate Professor of Medicine, University of Toronto.
"The approval of SPRIAFIL (posaconazole) for the prevention of IFIs in this
high-risk patient population has the potential to change medical practice in
this area because it may allow physicians to prevent these infections in the
first place."
    The frequency and relative importance of infection caused by Aspergillus
species are on the rise in all developed countries, which is possibly related
to increased numbers of immunocompromised patients.(4)
    "There is an unmet medical need worldwide for new drugs to treat serious
invasive fungal infections in immunocompromised or immunosuppressed
individuals, such as cancer patients undergoing chemotherapy or bone marrow
transplantation," said Dr. Michel Laverdière, Professor of Medical
Microbiology and Infectious Diseases University of Montréal, Director,
Diagnostic Laboratories Program, Hopital Maisonneuve-Rosemont. "With new
treatments like SPRIAFIL, which can now both treat and prevent these
life-threatening fungal infections, while treating the patient's underlying
cancer."
    SPRIAFIL (posaconazole) is a novel triazole agent which has been
demonstrated to offer superior treatment and prevention of a broad spectrum of
common, rare and emerging pathogens, including those with limited treatment
options(5,6,7,8). SPRIAFIL's (posaconazole) oral dosing also provides
continuity of care in and out of hospital.
    Health Canada's approval of SPRIAFIL (posaconazole) for prophylaxis is
based primarily on the results of two head-to-head randomized clinical
studies, published recently in The New England Journal of Medicine. These are
the largest prophylaxis studies conducted to date in high-risk patient
populations, with more than 1,200 patients enrolled in the studies.(9,10) In
high-risk neutropenic (low white blood cell count) patients, prophylaxis with
SPRIAFIL (posaconazole) was associated with a decrease in all cause mortality
versus the comparator drugs.(11) SPRIAFIL (posaconazole) has also been proven
to treat patients with invasive aspergillosis who are refractory or intolerant
of previous antifungal therapy.(12)
    SPRIAFIL (posaconazole) is a new antifungal agent, developed for both the
prevention and management of invasive fungal infections. SPRIAFIL
(posaconazole) is indicated in Canada for:
    
    -  the prophylaxis of Aspergillus and Candida infections in patients,
       13 years of age and older, who are at high risk of developing these
       infections.
    -  the treatment of invasive aspergillosis in patients 13 years of age or
       older with disease that is refractory to amphotericin B or
       itraconazole, or in patients who are intolerant of these medicinal
       products.
    

    SPRIAFIL (posaconazole) is also approved by Health Canada for the
treatment of oropharyngeal candidiasis (OPC) in patients 13 years of age or
older. OPC is a fungal infection of the mouth and throat caused by the yeast
Candida and is often referred to informally as thrush.

    SPRIAFIL (posaconazole) Safety Information

    Clinical studies have demonstrated that SPRIAFIL (posaconazole) Oral
Suspension is generally safe and 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. Treatment-related SAEs reported in
patients with IFIs  (1% each) included altered concentration of other
medicinal products, increased hepatic enzymes, nausea, rash, and vomiting.
Adverse events were reported more frequently in the pool of patients with
refractory OPC. Among these highly immunocompromised patients with advanced
HIV disease, SAEs were reported in 55%. The most commonly reported SAEs were
fever (13%) and neutropenia (10%). Treatment-related SAEs were reported for
14% of these patients and included neutropenia (5%) and abdominal pain (2%).
    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 should be
evaluated at the start of and during the course of SPRIAFIL (posaconazole)
therapy. Patients who develop abnormal liver function tests during SPRIAFIL
(posaconazole) therapy should be monitored for the development of more severe
hepatic injury. Patient management should include laboratory evaluation of
hepatic function (particularly liver function tests and bilirubin).
Discontinuation of SPRIAFIL (posaconazole) should be considered if clinical
signs and symptoms are consistent with development of worsening liver disease.
    SPRIAFIL (posaconazole) has been associated with prolongation of the QT
interval of the electrocardiogram (ECG) in some patients. Prolongation of the
QT interval may increase the risk of arrhythmia. SPRIAFIL (posaconazole)
should be administered with caution to patients with potentially proarrhythmic
conditions. Caution should be exercised if SPRIAFIL (posaconazole) is used in
patients taking other drugs that may prolong the QT interval.
    Co-administration with the CYP3A4 substrates terfenadine, astemizole,
cisapride(1), 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.
    Drugs whose concomitant use should be avoided: cimetidine, rifabutin and
phenytoin. Drugs whose concomitant use requires consideration of dose
reduction at initiation of concomitant treatment and close therapeutic
monitoring of drug levels during treatment: cyclosporine, tacrolimus and
sirolimus. Drugs whose concomitant use requires consideration of dose
reduction and close monitoring for adverse events during treatment: vinca
alkaloids, midazolam, HMG-CoA reductase inhibitors (statins), calcium channel
blockers.
    The safety and effectiveness of SPRIAFIL (posaconazole) in patients below
the age of 13 years old have not been established.

    -----------------------------------------
    (1) Terfenadine, astemizole, cisapride are no longer available on the
    Canadian market.

    ABOUT SPRIAFIL (posaconazole)

    SPRIAFIL (posaconazole) is a novel triazole antifungal agent discovered
and developed by Schering-Plough Research Institute. SPRIAFIL (posaconazole)
provides broad spectrum coverage for patients at high risk of developing IFIs
and for the treatment of refractory fungal infections, due to its clinical
efficacy, oral administration and safety profile, including limited drug
interactions and safety in renal impairment.
    SPRIAFIL (posaconazole) is also available in the United States and in
certain EU countries and international markets, including: Germany, France,
U.K, Spain, Portugal, Austria, Slovakia, Finland, Netherlands, Denmark,
Sweden, Norway, Greece and Australia.
    SPRIAFIL (posaconazole) received marketing approval for prophylaxis in
the United States and European Union (EU) in 2006.(3,4) SPRIAFIL
(posaconazole) was also approved in the United States and EU in 2006 for the
treatment of OPC, and in the EU in 2005 and Australia in 2006 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(13).

    About Schering-Plough Canada Inc.

    Schering-Plough Canada Inc. is a country operation of Schering-Plough
Corporation that employs over 850 people across Canada. Schering-Plough Canada
Inc.'s web site is www.schering-plough.ca.
    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 approximately 33,500 people
around the world. The company is based in Kenilworth, NJ, and its website is
www.schering-plough.com.

    SPRIAFIL(R) is a registered trademark of Schering Corporation, used under
license by Schering-Plough Canada Inc.
    (C) Schering-Plough Canada Inc. 2007. All rights reserved.


    NOTE: Medical experts are available for interviews in English and French.

    
    References:
    ------------------------------
    (1)  SPRIAFIL(R) (posaconazole) Product Monograph, March 23, 2007.
    (2)  Bow, Eric J., Laverdiere, Michel, Lussier, Nathalie et al.
         Antifungal Prophylaxis for Severely Neutropenic Chemotherapy
         Recipients. Cancer 2002; 94:3230-46.
    (3)  De Pauw, Ben E., Donnelly, J. Peter. Prophylaxis and Aspergillosis -
         Has the Principle Been Proven?. N Engl J Med 2007; 356: 409-411
    (4)  Stevens DA, Kan VL, Judson MA, et al. Practice guidelines for
         diseases causes by Aspergillus. Clin Infec Dis. 2000;30:697
    (5)  SPRIAFIL Product Monograph, March 23, 2007
    (6)  Ullmann AJ, Lipton JH, Vesole DH, et al. SPRIAFIL(R) or Fluconazole
         for Prophylaxis in Severe Graft-versus-Host Disease. N Engl J Med
         2007;356:335-47
    (7)  Cornely OA, Maertens J, Winston DJ, et al. SPRIAFIL(R) vs.
         Fluconazole or Itraconazole Prophylaxis in Patients with
         neutropenia. N Engl J Med 2007;356:348-59.
    (8)  Walsh, Thomas J., Issam, Raad, Patterson, Thomas F. et al. Treatment
         of Invasive Asperigillosis with Posaconazole in Patients Who Are
         Refractory to or Intolerant of Conventional Therapy: An Externally
         Controlled Trial. CID 2007:44
    (9)  Ullmann AJ, Lipton JH, Vesole DH, et al. SPRIAFIL or Fluconazole for
         Prophylaxis in Severe Graft-versus-Host Disease. N Engl J Med
         2007;356:335-47.
    (10) Cornely OA, Maertens J, Winston DJ, et al. SPRIAFIL(R) vs.
         Fluconazole or Itraconazole Prophylaxis in Patients with
         neutropenia. N Engl J Med 2007;356:348-59.
    (11) Cornely OA, Maertens J, Winston DJ, et al. SPRIAFIL(R) vs.
         Fluconazole or Itraconazole Prophylaxis in Patients with
         neutropenia. N Engl J Med 2007;356:348-59.
    (12) Walsh, Thomas J., Issam, Raad, Patterson, Thomas F. et al. Treatment
         of Invasive Aspergillosis with Posaconazole in Patients Who Are
         Refractory to or Intolerant of Conventional Therapy: An Externally
         Controlled Trial. CID 2007:44
    (13) Walsh, Thomas J., Issam, Raad, Patterson, Thomas F. et al. Treatment
         of Invasive Aspergillosis with Posaconazole in Patients Who Are
         Refractory to or Intolerant of Conventional Therapy: An Externally
         Controlled Trial. CID 2007:44
    




For further information:

For further information: Julie Wu, Schering-Plough Canada Inc., (514)
428-8815, julie.wu@spcorp.com; Rosalind O'Connell, Manning Selvage & Lee,
(416) 847-1321, rosalind.o'connell@mslpr.ca

Organization Profile

SCHERING-PLOUGH CANADA INC.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890