NOVARTIS' WET AMD DRUG APPROVED IN THE EU

Novartis' Lucentis has received approval in Europe as a new treatment for patients with wet age-related macular degeneration (AMD), the company announced.

According to Novartis, Lucentis (ranibizumab) is the first therapy shown in clinical trials to improve vision and vision-related quality of life in a significant number of people with wet AMD. The drug 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.

The European Commission's decision comes just 11 months after the application submission and applies to all 27 European Union (EU) member states as well as Iceland and Norway. Novartis said it will launch Lucentis in European countries throughout 2007 and 2008.

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

The pivotal studies submitted in the regulatory filings for Lucentis and recently published in the New England Journal of Medicine show an unprecedented response rate among wet AMD patients. Approximately 95 percent 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. Additionally, more than 68 percent of Lucentis-treated patients gained some vision, which is defined as any increase above baseline visual acuity.

"Looking into the future, Novartis has clinical trials under way to evaluate the safety and efficacy of Lucentis in other eye diseases, such as diabetic macular edema," James Shannon, global head of development at Novartis, said.