Health Canada approves ERAXIS(TM) (anidulafungin), a new antifungal agent with potent effect against life-threatening fungal infections



    KIRKLAND, QC, Nov. 27 /CNW/ - Pfizer Canada Inc. announced today that
Health Canada has given its approval to ERAXIS(*) (anidulafungin), a new
hospital treatment for invasive candidiasis/candidemia in adult
non-neutropenic patients.
    Invasive candidiasis is a leading cause of death from hospital-acquired
infections in Canada, with crude mortality rates ranging between 38 and
46 percent(1). Critically ill patients, those suffering from cancer or those
having undergone an organ transplant, are at the greatest risk for invasive
Candida infections.
    Rates of resistance to standard antifungal treatments are rising. ERAXIS
has been shown to be an effective new agent in the treatment of invasive
candidiasis in a phase 3 trial involving 47 trial sites in Canada, the U.S.
and Europe, of which eight were headed by Canadian researchers. Results of the
study were published in June 2007 in The New England Journal of Medicine(2).
    "There is a very real need for effective agents to treat critically ill
hospitalized patients who are affected by fungal infections that can threaten
their life," said Dr. Coleman Rotstein, Professor of Medicine and Director of
the Division of Infectious Diseases at McMaster University, Hamilton, Ontario,
and one of the lead researchers in the study. "We have seen excellent efficacy
with ERAXIS demonstrating proven response by both reducing the symptoms and by
eradicating the fungus. This means better outcomes for our most vulnerable
patients."
    ERAXIS (anidulafungin), belongs to a class of anti-infective agents,
called echinocandins, that have a potent anti-candida effect. ERAXIS is
administered intravenously, and is used to treat Candida infections of the
blood stream (candidemia), and other forms of Candida infections, including
abdominal abscesses and peritonitis (inflammation of the lining of the
abdominal cavity).
    "We are very pleased to have the opportunity to develop and bring to
patients another important new medicine that is proven to save lives," said
Dr. Bernard Prigent, Vice President & Medical Director, Pfizer Canada.
"Pfizer's role in this research and development demonstrates our commitment to
Canadian healthcare by providing the support required to ensure Canadians have
access to innovative new medicines."
    ERAXIS will be available to Canadian hospitals early in 2008.

    Clinical Data Support

    Clinical data was collected in a randomized, double-blind, phase 3 trial
involving 47 trial centres in which anidulafungin was compared with a standard
agent, fluconazole, for the treatment of candidemia and other forms of
invasive candidiasis. A successful global response required both clinical
success (defined as the resolution of signs and symptoms of invasive
candidiasis and no additional systemic antifungal therapy) and microbiologic
success (defined as the eradication of Candida species present at baseline as
determined on follow-up culture, or the presumed eradication if culture data
were not available for a patient with a successful clinical response). At the
end of intravenous therapy, the global success rate was 75.6% of patients
treated with anidulafungin, as compared to 60.2% of those treated with
fluconazole. Global success at the 2-week and 6-week follow up periods
favoured anidulafungin.
    ERAXIS was generally well tolerated in clinical studies. The majority of
adverse events were considered to be mild or moderate in severity. As per the
Canadian product monograph, no clinically-relevant drug-drug interactions were
observed during clinical trials. Additionally, no dose adjustments are
required for any degree of hepatic or renal insufficiency, age, gender,
weight, ethnicity or HIV positivity(3).

    About Pfizer Canada Inc.

    Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's
leading pharmaceutical company. Pfizer discovers, develops, manufactures and
markets prescription medicines for humans and animals. Pfizer Inc invests more
than US$7 billion annually in R&D to discover and develop innovative
life-saving and life-enhancing medicines in a wide range of therapeutic areas,
including arthritis, cardiovascular disease, endocrinology, HIV/AIDS,
infectious disease, neurological disease, oncology, ophthalmology and smoking
cessation. For more information, visit www.pfizer.ca.

    These press releases were issued in Canada and are intended as reference
information for Canadians. The information contained in each press release was
accurate at the time of issuance, and Pfizer Canada assumes no responsibility
for updating the information to reflect subsequent developments.

    
    -------------------------------------
    (1) Laupland KB, Gregson DB, Church DL, et al. Invasive Candida species
        infections: a 5 year population-based assessment. J Antimicrob
        Chemother. 2005; 56(3): 532-7.
    (2) Reboli AC et al. Anidulafungin versus fluconazole for invasive
        candidiasis. N Eng J Med 2007;356(24):2472-82.
    (3) Canadian Product Monograph.
    





For further information:

For further information: Julie-Catherine Racine, Pfizer Canada Inc.,
(514) 693-4602; Fiona Robinson, Hill & Knowlton Canada, (416) 413-4737,
fiona.robinson@hillandknowlton.ca


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