Health Canada Approves New Cream Treatment for Skin Cancer

          ALDARA is the first new treatment approved in Canada 
                   for basal cell carcinoma in 30 years
    
                   Pro Golfer David Barr urges Canadians 
                    to take action against skin cancer

    TORONTO, Jan. 6 /CNW/ - Health Canada has approved ALDARA(TM) (imiquimod)
Cream, 5%, a topical prescription medication for the treatment of superficial
basal cell carcinoma (sBCC) - a form of non-melanoma skin cancer. ALDARA is
the first new treatment for this type of cancer to be approved in Canada in
close to 30 years and is the first in a new class of medications called immune
response modifiers. The medication works by triggering the body's immune
system to find and kill mutated cells on the outer layer of the skin.
    "Standard skin cancer treatment options include scraping, burning,
radiation, or surgically removing cancer lesions from the skin, which can be
uncomfortable and sometimes disfiguring," says Dr. Goldstein, consultant
dermatologist at the University Health Network, Toronto Western Hospital. "But
with the availability of ALDARA for sBCC, Canadians have another effective
option, which is associated with little or no discomfort, and may not cause
the long-term scarring that can be seen with more invasive treatments. This
therapy can replace surgical options for superficial BCCs, with good cure
rates and an acceptable side effect profile."
    Skin cancer is the most common of all cancers affecting approximately
82,000 Canadians(1). Over the last 15 years its incidence has increased by 
two-thirds (67 per cent)(2). Basal cell carcinoma accounts for 80 per cent of
all skin cancers(3).
    "When I was diagnosed with basal cell carcinoma (BCC), I was shocked -
skin cancer was never something I was concerned about," says Canadian Hall of
Fame and Senior PGA Championship golfer, David Barr. "Now I know the
importance of examining my skin regularly and seeing my doctor if I notice
anything unusual. For many of us the damage from years of sun exposure is
already done, so early detection is crucial. If caught early, BCC is highly
treatable."
    ALDARA is a cream that is applied at home by the patient and unlike most
approved therapies, is non-invasive, which means it does not involve surgery.
In clinical trials involving 364 patients with primary sBCCs, 82 per cent of
patients treated with ALDARA achieved complete disease clearance confirmed by
biopsy, compared with only three per cent in the placebo group(4).
    "Finding effective and patient-friendly options is important in advancing
the treatment of non-melanoma skin cancer," comments Dr. Jason Rivers,
dermatologist and active staff member at the British Columbia Cancer Agency,
and professor of dermatology at the University of British Columbia in
Vancouver. "Not only is ALDARA effective, but it's exciting because it works
with the body's own immune system to fight cancer from within, rather than
treating it invasively from the outside."
    ALDARA is applied five times per week, for six weeks, to sBCC lesions
with a maximum diameter of two centimetres, confirmed by biopsy, located on
the trunk of the body, neck, or extremities (excluding hands and feet). In
clinical trials, the most frequent reactions reported by ALDARA patients were
local skin reactions, including erythema (redness), and scabbing at the
application site. Although 97 per cent of patients reported erythema, only
three per cent reported pain and only one per cent of patients discontinued
treatment due to local skin or application-site reactions. Scarring was not
reported as a result of ALDARA treatment at the 12 week post-treatment
evaluation.
    ALDARA was first approved by Health Canada in 1999 for the treatment of
external genital and perianal warts, caused by the human papillomavirus (HPV).
In June 2004, Health Canada approved ALDARA for the treatment of actinic
keratosis, a precancerous skin condition that can lead to squamous cell
carcinoma, another form of non-melanoma skin cancer.

    Basal Cell Carcinoma
    Basal cell carcinoma affects approximately 65,000 Canadians(5).
Superficial BCC is a type of BCC that typically occurs on the torso and may
appear on the face. It appears as well-defined, red, scaly patches that can
resemble eczema or psoriasis. Like other skin cancers, sBCC is caused by over
exposure to the sun's damaging rays.
    Basal cell carcinoma lesions generally grow slowly and have up to a
95 per cent treatment success rate if caught early(6). If left untreated,
BCC tumours can continue to grow, eventually invading and causing damage to
surrounding tissues.

    3M Canada
    3M Canada is the marketer of ALDARA. 3M Pharmaceuticals, a division of
3M Canada Company, develops, manufactures and sells prescription drug products
related to dermatology, sexual health, and respiratory conditions. 3M Canada
Company employs over 1,800 people across Canada and has annual sales exceeding
$1billion (CDN). Additional information is available at www.3m.ca
    Worldwide, 3M Company is a $16 billion (US) diversified technology
company with leading positions in industrial, consumer, office, health care,
safety and electronics, telecommunications and other markets.

    3M and ALDARA are trademarks of 3M. Used under license in Canada.

    NOTE TO TELEVISION STATIONS:
    B-roll will be available on January 6, 2005 from 11:00 - 11:30 EST and
14:00 -14:30 EST at the following coordinates:
    Anik E2F C Band, Transponder 5 Baker, audio subcarriers 6.2/6.8. Down
link frequency 3900 vertical polarity


    References:
    -----------------------------------
    (1) National Cancer Institute of Canada: Canadian Cancer Statistics 2004.
    (2) Ibid.
    (3) Alam M, Datner D. Cutaneous squamous cell carcinoma. New Eng J Med.
        2001; 334 (13): 975-983
    (4) Geisse et.al. Imiquimod 5% cream for the treatment of superficial
        basal cell carcinoma: Results from two phase III, randomized,
        vehicle-controlled studies. J. Amer. Acad. Dermatol. May 2004:
        722-733.
    (5) National Cancer Institute of Canada: Canadian Cancer Statistics 2004.
    (6) American Accreditation HealthCare Commission for Medline Plus Medical
        Encyclopedia: Basal cell carcinoma. Available at
        http://www.nlm.nih.gov/medlineplus/ency/article/000824.htm
        (Accessed October 19, 2004).

For further information: Environics Communications: Jennifer Casey, 
(416) 969-2724, jcasey@environicspr.com; Sacha Tynan, (416) 969-2716, 
stynan@environicspr.com

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