FDAnews
www.fdanews.com/articles/63268-roche-and-trimeris-provide-update-on-development-of-needle-free-administration-for-fuzeon

ROCHE AND TRIMERIS PROVIDE UPDATE ON DEVELOPMENT OF NEEDLE-FREE ADMINISTRATION FOR FUZEON

October 12, 2006

Roche and Trimeris, Inc. provided an update on the companies' development plans for administration of FUZEON (enfuvirtide) with a needle-free injection device (Biojector 2000, B2000). In recent discussions with FDA regarding the submission of an amended sNDA for inclusion of the B2000 device as an administration option for FUZEON, the agency acknowledged that, based on currently available evidence, administration with B2000 achieves similar blood levels of FUZEON compared to standard needle-syringe administration.

Genetic Engineering News (http://www.genengnews.com/news/bnitem.aspx?name=6824654)