Inclusion of untested cancer drug clouds BC government announcement recognizing needs of persons with wet age-related macular degeneration



    DORVAL, QC, April 8 /CNW Telbec/ - Novartis Pharmaceuticals Canada is
pleased that the government of British Columbia has recognized the challenges
facing patients with wet age-related macular degeneration (AMD) with its
announcement today of a program to fund new treatments for the disease,
including the Novartis medication Lucentis(*) (ranibizumab).
    However, Novartis is concerned about the inclusion in the program of the
cancer drug Avastin (bevacizumab) which has not been tested or approved for
treating the disease. As well, since the government's announcement contained
no details about exactly how the new treatments will be made available, the
extent to which BC patients will benefit from this announcement is not yet
clear. Novartis will work closely with the BC government and doctors to ensure
the new program is implemented as efficiently as possible.
    Lucentis(*) is the first and only treatment for wet AMD that has been
specifically developed to treat the disease and has been shown in studies to
improve the sight of persons with the disease. The treatment, which is
administered by injections into the eye, was approved by Health Canada in June
2007 and was recommended as cost-effective and suitable for reimbursement by
provincial drug plans by the Common Drug Review in March 2008. Since that
time, persons in BC with wet AMD have been anxiously awaiting news that would
provide reimbursement of the treatment through the BC Pharmacare program.
    Avastin has not been tested or proven safe to treat wet AMD and both
Health Canada and the provider of the drug in Canada, Roche, have discouraged
its off-label use to treat wet AMD. Novartis believes Canada's health system
and provincial drug plans should rely on scientific rather than anecdotal
evidence to make its decisions about appropriate treatments, and that given
the availability of Lucentis(*) with its scientifically backed track record of
efficacy and safety, the use of the cancer medicine Avastin for wet AMD should
be discouraged, in accordance with Health Canada recommendations. Novartis is
dismayed that British Columbia is not following the advice of Health Canada by
becoming the first province to include Avastin in a wet AMD treatment program.
    Novartis is committed to working with the government of British Columbia
to allow BC residents access to Lucentis(*). Novartis has also offered the BC
government to absorb some of the cost of reimbursing Lucentis(*), as it does in
other Canadian provinces. Lucentis(*) is currently reimbursed in Quebec,
Ontario, Saskatchewan and Yukon while Newfoundland and Labrador announced in
its recent budget that reimbursement would be forthcoming.

    About AMD

    Nearly 300,000 Canadians suffer from wet AMD. It is anticipated that
20,000 new cases of wet AMD will be diagnosed in Canada this year alone, a
number expected to double within the next 25 years. AMD is a progressive
disease that causes rapid and severe central vision loss in a matter of a few
weeks to months and can severely compromise a person's ability to function
independently. AMD can lead to vision loss and blindness. Wet AMD is
responsible for 90% of vision loss associated with AMD.

    About Lucentis(*)

    Lucentis(*) is the first and only approved treatment clinically proven to
not only stop progression of wet AMD, but also to restore vision, increasing a
patient's ability to perform activities requiring central vision such as
seeing faces, reading and driving.
    Lucentis(*) 0.5 mg is recommended to be administered by intravitreal
injection once a month. The treatment is initiated with a loading phase of one
injection per month for three consecutive months, followed by a maintenance
phase in which patients should be monitored for visual acuity on a regular
basis. If the patient experiences a loss of greater than 5 letters in visual
acuity (Early Treatment Diabetic Retinopathy Study (ETDRS) or one Snellen line
equivalent), or clinical or diagnostic evidence of disease activity, Lucentis(*)
should be administered.
    Of the close to 1,500 patients who were followed in clinical trials, most
reported side effects were mild to moderate and generally reversible. Serious
ocular adverse events related to the injection procedure are rare and could
include inflammation of the interior of the eye, tear or detachment of the
retina or traumatic cataract. In the MARINA trial, the rate of inflammation of
the interior of the eye (endopthalmitis), one of the more serious potential
adverse events with Lucentis(*) administration, was 0.05%, or 5 cases out of
10,443 total injections.
    Lucentis(*) was developed by Genentech and Novartis. Genentech has the
commercial rights to Lucentis(*) in the United States, while Novartis has
exclusive rights in the rest of the world.

    About Novartis Pharmaceuticals Canada Inc.

    Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2008, the Company
invested over $96 million in research and development. Novartis
Pharmaceuticals Canada Inc. employs approximately 800 people in Canada and its
headquarters are located in Dorval, Quebec. It was named again one of the "50
Best Employers in Canada" for 2009. For further information, please consult
www.novartis.ca.

    
    (*) Lucentis is a registered trademark of Genentech, Inc., used under
        permission by Novartis Pharmaceuticals Canada Inc.
    




For further information:

For further information: Silvie Letendre, Novartis Pharmaceuticals
Canada Inc., Cell. (514) 449-7872, silvie.letendre@novartis.com


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