By STEPHANIE BEASLEY
The National Institutes of Health announced the addition of five drug companies to a new program that would pair the companies with researchers
in order to repurpose pharmaceutical compounds that advanced to clinical studies but were not approved for their original indication.
On Tuesday (June 5) NIH said Abbott, Bristol-Myers Squib Company, GlaxoSmithKline, Janssen Pharmaceutical Research and Development, LLC and Sanofi would join the “Discovering New Therapeutic Uses for Existing Molecules” program at the National Center for Advancing Translational Sciences. The program was launched in May with three companies – Pfizer, AstraZeneca and Eli Lilly and Company – and 24 compounds, but will now expand to include 58 compounds that will be available to researchers seeking to find new therapeutic uses for the drugs.
The eight companies will also provide related data for the compounds which have advanced to phase I or phase II of the development process but have not been approved for their original indications or not pursued for business purposes.
“Each company participating in this innovative collaboration has made substantial research and development investments to advance these compounds to the point where they can be used in clinical studies,” said Kathy Hudson, NCATS’ acting deputy director. “If researchers funded through this effort can demonstrate new uses for the compounds, they could significantly reduce the amount of time it takes to get a treatment to patients in need.”
NCATS will allocate $20 million from the $575 million proposed for the center in the president’s fiscal 2013 budget to fund two-three year staged cooperative agreement research grants. Funded researchers will conduct pre-clinical validation and clinical feasibility studies in the first stage and proof-of-concept clinical trials in the second stage to determine whether the compound is effective against an unexplored disease target. NIH officials said the program will focus on the treatment of rare and genetic diseases as well as neurological disorders, in particular (see related story).
The pre-application deadline for researchers to apply for the program is Aug. 14.