Health Canada approves (Pr)Lucentis* to treat vision loss resulting from diabetic macular edema (DME)

First approved treatment of its class for the most-feared complication of diabetes and a leading cause of vision loss in working-aged adults

DORVAL, QC, Sept. 14, 2011 /CNW Telbec/ - Health Canada has approved Lucentis* (ranibizumab) as a treatment for vision loss resulting from diabetic macular edema (DME), one of the major causes of adult vision loss and an important complication of the growing epidemic of diabetes.1

For diabetics, the possibility of losing their eyesight is the most feared complication of their diabetes.  Visual impairment due to DME reduces patients' quality of life by compromising various activities such as ability to work, read and drive.2 DME is a consequence of diabetic retinopathy which usually progresses slowly with worsening symptoms and impact on vision.3

An estimated 2.5 million Canadians have diabetes. And like its parent disease, the sight-robbing condition DME does not discriminate against age. In fact, of the more than 70,000 Canadians whose vision is currently affected by DME, a significant number are of working age, with a recent study enrolling patients as young as 30.4

Laser therapy, the current standard of care, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis* is the first approved therapy to improve vision for patients with visual impairment due to DME.

"Lucentis* provides us for the first time a real opportunity to improve vision in persons with DME," said Dr. Peter Kertes, a vitreo-retinal surgeon and Ophthalmologist-in-chief of the John and Liz Tory Eye Centre at Sunnybrook Health Sciences Centre and Associate Professor in the Department of Ophthalmology and Vision Sciences at the University of Toronto. He was also an investigator in the studies that were reviewed by Health Canada for the approval of Lucentis* for this condition. "In one study, after 12 months a significantly greater proportion of patients treated with Lucentis* had vision in the treated eye at or above the international legal minimum for driving. This is a major achievement that has a meaningful impact on patients' lives."

One of the Canadian patients in the international trials studying Lucentis* in DME was Kash Joshi of Toronto. Diagnosed with diabetes in 1994, several years ago he started having troubles with blurry vision, which continued even after cataract surgery, at which point he enrolled in the Lucentis* study. "I noticed an improvement after the first injection, and it's kept on getting better," he said. "I had given up reading, except for short times with a magnifying glass. Now my eyesight is almost 20/20 and I read and do everything else without a problem. The difference is like night and day."

"The approval of Lucentis* to treat vision loss from DME is an important step forward in alleviating the burden of adult vision loss in Canada," said Sharon Colle, President and CEO of The Foundation Fighting Blindness, based in Toronto. "As an organization dedicated to research and finding a cure for retinal diseases, it's encouraging to see this very positive development. We hope persons with DME will quickly get access to Lucentis* through provincial drug plans."

Lucentis* was specifically developed as a treatment for visual impairment due to its effect on a protein that plays a critical role in the leakage of blood vessels in the retina of diabetic patients. Macular edema is a swelling of the macula from leaking of fluid from blood vessels, resulting in blurred vision.5 In the clinical trial RESTORE, Lucentis* has been shown to significantly improve vision compared to laser therapy, the current standard of care.6

About diabetic macular edema

DME is a common complication of diabetic retinopathy, which is caused by damage to the blood vessels of the retina and is the leading cause of vision loss in working-aged adults in the developed world.7,8 In people with diabetes, elevated blood sugar levels can lead to problems with the blood circulatory system. These problems can result in symptoms in various areas of the body, such as extremities, but also including the small blood vessels in the retina of the eye. These vessels then leak, which causes swelling (edema) of the macula, the centre of the retina responsible for sharp and straight ahead vision.9 Therefore, DME can lead to significant visual impairment.

The first symptoms of DME are most often "floaters" or spots in the line of vision, then blurry vision.  DME usually progresses slowly with worsening symptoms and is a lifelong condition. DME with visual impairment affects 2.6% of diabetics in Canada.10

About Lucentis*

Lucentis* (ranibizumab) was specifically designed for use in the eye and is administered by injection into the eye. It is licensed in more than 30 countries for the treatment of vision impairment due to diabetic macular edema (DME). Earlier this year, Lucentis* was also approved by Health Canada for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). Lucentis* is licensed in more than 85 countries, for wet age-related macular degeneration (AMD). It was approved by Health Canada in 2007 for the treatment of wet AMD and is available through the public health plans of all 10 provinces to treat that disease.

Canadian approval of Lucentis* for the treatment of visual impairment due to diabetic macular edema was based on data from the RESTORE study, involving 345 patients, in which patients treated with either Lucentis* alone or in combination with laser gained significantly more letters in visual acuity at 12 months compared to baseline  versus  patients treated with laser alone.  The safety profile of Lucentis* was consistent with the well-established profile in patients with wet age-related macular degeneration (wet AMD).

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 2010, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. It was named for the seventh time as one of the "50 Best Employers in Canada" for 2011. For further information, please consult www.novartis.ca.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "can," "commitment," "potentially," "ongoing," "will," or similar expressions, or by express or implied discussions regarding potential approvals to sell Lucentis* in additional markets or regarding potential future revenues from Lucentis* You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis* to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis* will be approved for sale in any additional markets. Nor can there be any guarantee that Lucentis* will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis* could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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

________________________

1Canadian Diabetes Association, "Diabetes: Canada at the Tipping Point," April 2011

2 Hariprasad SM et al. Vision-related quality of life in patients with diabetic macular oedema. Br J Ophthalmol. 2008:92. 89-92 and Davidov E et al, Diabetic retinopathy and health-related quality of life. Graefs Arch Clin Exp Ophthalmol, 2009:247:267-272

3,5,7,9 National Eye Institute at www.nei.nih.gov/health/diabetic/retinopathy.asp

4,10 Data on file, Novartis Pharmaceuticals Canada Inc.

6 Data on file, Novartis Pharma AG, Basel, Switzerland

8 Chou TH et al, Relationship of diabetic macular oedema with glycosylated haemoglobin. Eye. 2009:23:1360-1363.


SOURCE NOVARTIS PHARMACEUTICALS CANADA INC.

For further information:

or to arrange an interview, please contact:

Kara Euale
Hill & Knowlton Canada
Tel: 416-413-4695
kara.euale@hillandknowlton.ca

Julie Schneiderman
Novartis Pharmaceuticals Canada Inc.
Tel: 514-633-7880 ext. 1191
Mobile: 514-983-9912
julie.schneiderman@novartis.com

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