Health Canada approves Astellas' Mycamine(TM)



    A new anti-fungal treatment for Candida infections in immunocompromised
    patients

    MARKHAM, ON, June 21 /CNW/ - Mycamine(TM), (micafungin sodium for
injection) has been approved by Health Canada for the treatment of esophageal
candidiasis and the prophylaxis of Candida infections in patients undergoing
hematopoietic stem cell transplantation.(1) Mycamine, marketed by Astellas
Pharma Canada, Inc., is expected to be available in September 2007.
    Mycamine belongs to a new class of anti-fungal agents, the echinocandins,
which inhibit cell wall synthesis. Specifically, Mycamine blocks the synthesis
of 1,3-B-D-glucan, an integral fungal cell wall component. Fungal infections
are often a prevalent complication for immunocompromised patients, such as
those undergoing cancer treatment or who are HIV-positive.(1) Mycamine is the
first echinocandin to be approved for prophylaxis of Candida infections.
    The approval of Mycamine is based on 32 clinical studies conducted in the
United States, Canada, Japan, South America, Europe and Africa. The clinical
development program included data from 2,402 subjects. Patients in the
Mycamine studies included a broad range of individuals who had a confirmed, or
were at risk for, Candida fungal infections, including patients with
hematologic malignancies, bone marrow transplant recipients and HIV positive
patients.
    "The results of the clinical trials of Mycamine show this medication is
effective in preventing or treating opportunistic Candida fungal infections in
patients, such as those undergoing treatment for certain types of cancer or
who are HIV positive." says Barbara Reynolds, Director of Marketing, Astellas
Pharma Canada, Inc. "These results are encouraging and we are pleased to be
able to offer physicians another option to benefit their patients who may
suffer health complications as a result of a fungal infection."
    The role of Mycamine in the treatment of candidemia and invasive
candidiasis has been examined in a randomized, double-blind comparative trial
of Mycamine and AmBisome(R) (liposomal amphotericin B), a cornerstone of
treatment of fungal infections. Results were recently published in The Lancet,
May 5, 2007.(2) The international study involved 531 patients, enrolled at 115
sites between 2003 and 2004, who were being treated for candidemia or invasive
candidiasis.
    Results showed that Mycamine was as effective as AmBisome in treating
Candida infections. However, Mycamine demonstrated reduced toxicity, with
fewer side effects and treatment discontinuation than in patients receiving
AmBisome. AmBisome, an effective treatment for Candida infections, has been
associated with side effects including renal dysfunction, infusion related
toxicities and electrolyte imbalances. The effect of both treatments was
independent of the primary site of the infections and the patient's immune
system status, or whether patients had an indwelling catheter.
    Mycamine has now received marketing approval in seven countries for the
treatment of esophageal candidiasis and prophylaxis of Candida infections in
patients undergoing hematopoietic stem cell transplantation. Mycamine is also
approved and indicated for the treatment of candidemia and invasive
candidiasis in Japan, Jordan and China.

    About Mycamine
    --------------

    The novel mechanism of action of echinocandins specifically targets the
wall of fungal cells to treat or prevent the infection. Mycamine is
contraindicated in patients with hypersensitivity to any component of the
product. Patients receiving Mycamine have reported isolated cases of serious
hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock),
significant hemolysis and hemolytic anemia. The most common side effects
experienced in the clinical trials included changes in liver and renal
function. Possible histamine-mediated symptoms have been reported with
Mycamine, including rash, pruritus, facial swelling, and vasodilatation.
Injection site reactions, including phlebitis and thrombophlebitis, have been
reported at Mycamine doses of 50-150 mg/day.(1)

    About Astellas Pharma Canada, Inc.
    ----------------------------------

    Astellas Pharma Canada, Inc. is highly focused on customers and their
needs and is committed to making a difference in the treatment of infectious
diseases. Astellas Pharma Canada is dedicated to improving the health of
people around the world through the provision of innovative and reliable
pharmaceutical products. It is one of the Astellas Group of companies in North
America and an affiliate of Astellas Pharma Inc., located in Tokyo. The
organization is committed to becoming a global pharmaceutical leader by
combining outstanding R&D and marketing capabilities. Additional corporate
information is available at www.astellas.com/ca.

    Mycamine is a trade-mark of Astellas Pharma Inc.
    AmBisome is a registered trade-mark of Gilead Sciences, Inc., used under
    license.

    
    References
    ----------------------------------

    (1) Mycamine Product Monograph, Astellas Pharma Canada, Inc. April 9,
        2007.
    (2) Kuse ER, Chetchotisakd P, da Cunha CA, Ruhnke M, Barrios C, et al.
        Micafungin versus liposomal amphotericin B for candidaemia and
        invasive candidosis: a phase III randomised double-blind trial. The
        Lancet 2007; 369:1519-1527.
    





For further information:

For further information: Communications MECA, Lindsay Peterson,
1-866-337-3362 x229


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