Biotech Values

[DewDiligence]

Lucentis Approved by EU Commission

[This was a rubber-stamp approval of the positive recommendation from the CHMP in November. Lucentis is now approved in all major pharmaceutical markets except Japan, China, Canada, Brazil, and Australia. DNA has the marketing rights in the U.S. and NVS has them everywhere else.

One notable aspect of this PR is that it does not mention NVS’ other AMD drug, Visudyne. It’s hard to see why NVS would put much effort into that now. Despite the spin emanating from QLTI, NVS recognizes that the future of AMD treatment is not combination therapy with Visudyne and Lucentis.]

http://www.novartis.com

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24 Jan 2007 1:15 am ET

Lucentis® receives approval in the European Union - the first drug to improve vision in patients with wet AMD, a leading cause of blindness

• Lucentis the first and only treatment proven in clinical trials to maintain and improve vision in patients with the degenerative eye disease wet AMD

• Vision improvement with Lucentis treatment increases the ability of patients to perform everyday activities such as reading

• Wet AMD a leading cause of severe vision loss in people over age 50 in the Western world

Basel, January 24, 2007 - Lucentis® (ranibizumab) has received European Union approval as a new treatment for patients with wet age-related macular degeneration (AMD), a leading cause of severe vision loss in people over age 50 in the Western world.

Until now, available therapies have only been able to slow the decline in vision, not to improve it. Lucentis is the first therapy shown in clinical trials to improve vision and vision-related quality of life in a significant number of people suffering from wet AMD.

"The positive European Commission decision for Lucentis is a major breakthrough for the wet AMD community and gives hope to many of us," said MacDonald Curran, Chairman of AMD Alliance International, a non-profit alliance of organizations dedicated to the prevention and treatment of macular degeneration. "We now look forward to regulatory authorities in the EU member states continuing to recognize the value of Lucentis by reimbursing it as quickly as possible to avoid unnecessary blindness."

The pivotal studies used in the regulatory submissions for Lucentis and recently published in the New England Journal of Medicine[1],[2] show an unprecedented response rate among wet AMD patients. Approximately 95% of Lucentis-treated patients maintained their vision, as defined by a loss of less than 15 letters in visual acuity on the study eye chart. More than 68% of Lucentis-treated patients gained some vision, which is defined as any increase above baseline visual acuity. To date, this gain in vision has been sustained at two years with monthly Lucentis treatment.

The European Commission decision comes just 11 months after submission and applies to all 27 member states as well as Iceland and Norway. Novartis will launch Lucentis in European countries throughout 2007 and 2008 [i.e. pending reimbursement agreements from the national governments on a country-by-country basis].

In addition to the European Union, Lucentis is already approved for use in patients with wet AMD in Switzerland, India and the United States. Novartis expects regulatory decisions in Australia and Canada during the first half of 2007.

"With Lucentis, we have a new option for wet AMD patients that offers real hope," said Francesco Bandello, M.D., Full Professor and Chairman of the Department of Ophthalmology at the University of Udine, Italy. "Lucentis offers patients the possibility that they will not only gain some vision but also independence by restoring the ability to recognize faces and do day-to-day activities like reading."

Lucentis is designed to block the uncontrolled formation, growth and leakage of new blood vessels underneath the retina that lead to the development of the wet form of AMD and subsequent vision loss. Lucentis is given by intravitreal injection once a month for three months, followed by a maintenance phase in which patients are monitored monthly. Lucentis should be re-administered if a patient loses more than five letters in visual acuity.

"After nearly a decade of development, including rigorous clinical trials testing its safety and efficacy, Lucentis is the first treatment to show improvement in vision in a significant number of patients," said James Shannon, M.D., Global Head of Development at Novartis Pharma AG. "Looking into the future, Novartis has clinical trials underway to evaluate the safety and efficacy of Lucentis in other eye diseases, such as diabetic macular edema."

About AMD

AMD is a degenerative eye disease affecting 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. Approximately 25 to 30 million people worldwide are living with the disease.

There are two types of AMD: dry and wet. Neovascular, or 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 and destroys the macula.

Lucentis was developed by Genentech and Novartis Pharma AG. Genentech has the commercial rights to Lucentis in the US, while Novartis has exclusive rights in the rest of the world.
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