Feb. 19, 2014 – Under the terms of a partnership agreement made in 2009 with the gene-therapy developer Oxford BioMedica, the international pharmaceutical company Sanofi has been granted broadened global development and commercialization rights for two retinal disease gene therapies: StarGen™, for Stargardt disease, and UshStat®, for Usher syndrome type 1B. Sanofi is expected to take over management of the Phase I/II clinical trials during the first half of 2014.
Oxford BioMedica is eligible for development and commercialization milestone payments as well as royalties from future sales of the gene therapies. Oxford BioMedica has received $24 million for development funding and $3 million for license acquisition from Sanofi since the agreement was executed.
Sanofi and Oxford BioMedica will continue to partner in developing RetinoStat®, a gene therapy in a Phase I clinical trial for people with wet age-related macular degeneration.
“We are very pleased to see the companies proceed with their commercialization plans for making these promising gene therapies available to people with vision-robbing retinal diseases who desperately need them,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “Sanofi’s clinical-development expertise, global presence and financial strength are powerful resources for advancing these therapeutic programs.”
“The Foundation Fighting Blindness began investing aggressively in lab studies of these gene therapies in the late 1990s, when they were at a very early stage of development,” says William T. Schmidt, chief executive officer of the Foundation. “It is wonderful to see that support paying off in terms of both clinical and commercial advancement. That provides tremendous hope for our constituents.”
StarGen and UshStat are currently in Phase I/II clinical trials at Oregon Health & Science University (OHSU) and the Centre Hospitalier Nationale d’Ophthalmologie des Quinze-Vingts in Paris. The Foundation is providing support for the Paris UshStat study. The Phase I RetinoStat clinical study is underway at Johns Hopkins University, OHSU and the University of Iowa.