Genentech takes steps to protect Lucentis

Executive Summary

As of Nov. 30, Genentech will no longer allow compounding pharmacies to purchase its VEGF inhibitor Avastin from authorized wholesale distributors, the firm announces Oct. 11 in a letter to retinal physicians. The move is to prevent the off-label use of Avastin (bevacizumab), which is approved for oncologic uses, for wet age-related macular degeneration in place of Genentech's VEGF inhibitor Lucentis (ranibizumab), which is approved for AMD. Genentech's letter notes that "FDA raised concerns related to the sterility and repackaging of Avastin for ocular use in a warning letter to a compounding pharmacy and, separately, during a routine FDA inspection of our South San Francisco manufacturing facility, concerns were raised ... related to the ongoing ocular use of Avastin because it is not designed, manufactured or approved for this use." The National Eye Institute is running trials studying Avastin in ocular settings, including a head-to-head comparison with Lucentis in AMD (1"The Pink Sheet" April 16, 2007, p. 8)...