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Lucentis® receives positive European Union regulatory agency opinion for approval as new treatment for a leading cause of severe vision loss


Positive recommendation from the European Union’s Committee for Medicinal Products for Human Use (CHMP) comes just nine months after submission

Lucentis the first drug to improve vision in patients with “wet” age-related macular degeneration (AMD), setting new treatment standard for this degenerative eye disease

Vision improvement associated with Lucentis treatment correlates with a return of everyday activities such as reading, driving, telling time or identifying faces

Basel, November 17, 2006 - Novartis has received a positive opinion supporting European Union regulatory approval for Lucentis® (ranibizumab) as a new treatment option for patients with the “wet” form of age-related macular degeneration, the leading cause of severe vision loss in people over age 50 in the western world.

The Committee for Medicinal Products for Human Use (CHMP), which reviews drug applications for all 25 countries in the European Union as well as Iceland and Norway, recommended approval of Lucentis. The European Commission generally follows the recommendation of the CHMP, and delivers its final decision within two to three months.

The positive opinion in Europe came only nine months after submission and comes after earlier approvals for Lucentis in Switzerland, India and the United States. Regulatory submissions for Lucentis have been based on three Phase III clinical trials, including two pivotal studies that were published in October 2006 in the New England Journal of Medicine.

“With Lucentis, the future of wet AMD treatment is certainly brighter than ever,” said Ursula Schmidt-Erfurth, MD, Professor and Chairman, Department of Ophthalmology, University of Vienna. “Lucentis gives real hope to wet AMD patients since it is the first and only therapy proven in clinical trials to help them regain vision on average. This means that many patients may regain the ability to do everyday activities such as reading, driving a car, cooking or going up and down stairs--ultimately helping to restore their independence.”

AMD is a degenerative eye disease that affects the macula - the central part of the retina at the back of the eye that is responsible for the “straight ahead” central vision necessary for everyday activities like reading, driving, telling time or identifying faces.

There are two types of AMD: dry and wet. Wet AMD accounts for about 15% of all AMD cases, but the majority of vision loss. It is associated with the growth of pathological new vessels under the macula that are fragile and leak fluid and blood. If not treated, scar tissue develops that destroys the macula.

“This positive recommendation highlights the important unmet need in the wet AMD patient population and the fact that Lucentis is a true breakthrough treatment,” said Nicholas Franco, Head of Novartis Ophthalmics. “Novartis now looks forward to final European Commission approval, and being able to provide European wet AMD sufferers access to Lucentis as quickly as possible.”

About Lucentis®
Lucentis® (ranibizumab) has been shown in clinical trials to maintain and improve vision and vision-related quality of life in people suffering from neovascular, or “wet,” age-related macular degeneration (AMD). A therapeutic antibody fragment designed specifically for treating conditions of the eye, Lucentis blocks all known biologically active forms of vascular endothelial cell growth factor A (VEGF-A), the molecule believed to be a major underlying cause of wet AMD. Lucentis was developed by Genentech and Novartis Pharma AG. Genentech has the commercial rights to Lucentis in the United States, while Novartis Pharma AG has exclusive rights in the rest of the world.

The foregoing release contains forward-looking statements that can be identified by terminology such as “recommended for approval”, “generally follows”, “future”, “may”, “looks forward to”, or similar expressions, or by express or implied discussions regarding potential approvals to market Lucentis in additional markets or potential future sales of Lucentis, or regarding the long-term impact of a patient’s use of Lucentis. Such forward-looking statements 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 market. Nor can there be any guarantee regarding potential future sales of Lucentis. Neither can there be any guarantee regarding the long-term impact of a patient’s use of Lucentis. 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 additional analysis of existing clinical data, or new 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; 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 this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

About Novartis Ophthalmics
With worldwide headquarters in Basel, Switzerland, the Novartis Ophthalmics Business Unit is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular allergies and other disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. Novartis products are made in Switzerland, France, the United States and Canada.

About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 people and operate in over 140 countries around the world. For more information, please visit

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