Canadian Agency for Drugs and Technologies in Health (CADTH) recommends provincial and publicly funded drug plans reimburse (Pr)Lucentis* to treat vision loss resulting from diabetic macular edema (DME)

Positive recommendation based on treatment's efficacy and cost effectiveness

DORVAL, Quebec, March 28, 2012 /CNW/ - The Canadian Agency for Drugs and Technologies in Health (CADTH) has positively recommended to Canada's provincial and other publicly funded drug plans that they reimburse the Novartis Pharmaceuticals Canada Inc. ("Novartis") drug Lucentis* (ranibizumab) to treat 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

Novartis made its submission to CADTH following the approval by Health Canada in September 2011 of Lucentis* to treat vision loss resulting from DME. The recommendation is based on a review of clinical evidence, cost-effectiveness and multiple patient group submissions. Lucentis* is the first approved pharmacological therapy to improve vision for patients with visual impairment due to DME.

"We are very pleased that CADTH has recognized the value Lucentis* brings to the Canadian healthcare system by making this positive recommendation," said Janice Murray, Vice President Ophthalmics Business Franchise of Novartis Pharmaceuticals Canada Inc. "We hope this will encourage provincial drug plans to provide reimbursement of Lucentis* as soon as possible to those with vision loss resulting from DME."

CADTH, through the Common Drug Review (CDR) is a single process to make recommendations to provincial and other public drug plans on the efficacy and cost effectiveness of new drugs. All provinces participate except Quebec, which has its own process. CADTH's recommendations are not binding on the participating drug plans, which will make their own listing decisions concerning Lucentis* in the treatment of vision loss resulting from DME.

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, which has been regarded as the standard of care, provides stabilization of vision in many patients, but generally does not improve vision. In the clinical trial RESTORE, Lucentis* was shown to significantly improve vision compared to laser therapy in patients with visual impairment due to DME.⁵

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.^6,7 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.⁸ 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.⁹

About Lucentis*

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

Canadian approval of Lucentis* for the treatment of visual impairment due to DME 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 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 2011, the company invested close to $92 million in research and development 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.

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¹ Canadian 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

^3,6,8 National Eye Institute at www.nei.nih.gov/health/diabetic/retinopathy.asp

⁴ Barbeau M, Gonder J, Walker V, Maschio M, Zaour N et al. C-Reality (Canadian Burden of Diabetic Macular Edema Observational Study): Three-Month Findings. Value in Health Vol. 14, Issue 7, Page A504

⁵ Mitchell P, Bandello F, Schmidt-Erfurth U,  et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology, 2011 Apr;118(4):615-25.

⁷ Chou TH et al, Relationship of diabetic macular oedema with glycosylated haemoglobin. Eye. 2009:23:1360-1363.

⁹ Petrella RJ, Davies B, Blouin J, Barbeau M. Prevalence, demographics and treatment characteristics of visual impairment due to diabetic macular edema in a representative Canadian cohort. Value in Health, Volume 14, Issue 7, November 2011, Page A502

Julie Schneiderman
Novartis Pharmaceuticals Canada Inc.
Tel: [phone] ext. 1191
Mobile: [phone]
[email protected]