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.

      -30-  /For further information: Silvie Letendre, Novartis Pharmaceuticals Canada Inc., Cell. (514) 449-7872, silvie.letendre@novartis.com/   
 

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