Ranibizumab fast-track designation denied; Genentech plans to file complete application

October 1, 2005

South San Francisco—Genentech Inc. said it intends to file a complete Biologics License Application (BLA) in December for its ranibizumab (Lucentis) treatment for the wet form of age-related macular degeneration (AMD). In addition, the company said it was recently notified that the FDA denied a request for fast-track designation for the investigational drug, which would allow for a rolling BLA submission.

South San Francisco-Genentech Inc. said it intends to file a complete Biologics License Application (BLA) in December for its ranibizumab (Lucentis) treatment for the wet form of age-related macular degeneration (AMD). In addition, the company said it was recently notified that the FDA denied a request for fast-track designation for the investigational drug, which would allow for a rolling BLA submission.

"We recognize the significant unmet medical needs of those with wet AMD and hope to make Lucentis available to patients by seeking FDA approval as quickly as possible," said Hal Barron, MD, Genentech senior vice president, development and chief medical officer.

The FDA ruling will not affect the timing for BLA submission in December or the potential to obtain priority review for ranibizumab, Genentech said in a prepared statement.

The phase IIIb study would evaluate the safety of two doses (0.3 and 0.5 mg) of ranibizumab in a broad population of patients with wet AMD. Patients would receive the drug once a month for 3 months with criteria-based re-treatment options, according to Genentech. The company said it anticipates that patients with wet AMD who have not received prior treatment for their disease, or who continue to have active disease despite treatment with FDA-approved therapies, may be eligible for enrollment in the phase IIIb study.

Genentech said the study is expected to begin before the end of 2005 and would enroll approximately 5,000 patients. The study will be conducted at more than 100 U.S. sites.