Biotech Values

[DewDiligence]

CHMP Approves Lucentis

[Formal clearance for marketing in the EU should come in 2-3 months. NVS has commercial rights to Lucentis in the entire world except the U.S.]

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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.
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