North Carolina-based Chelsea Therapeutics has entered into an exclusive license agreement with Japan's Dainippon Sumitomo Pharma (DSP) for the global development and commercialization rights to L-Threo DOPS (L-DOPS or Droxidopa), excluding Japan, Korea, China and Taiwan. Droxidopa is a synthetic amino acid for the treatment of neurogenic orthostatic hypotension.
Droxidopa is currently marketed in Japan by DSP. The compound initially received approval in 1989 for the treatment of frozen gait or dizziness associated with Parkinson's disease, and for the treatment of orthostatic hypotension, syncope or dizziness associated with Shy-Drager syndrome and familial amyloidotic polyneuropathy. In 2000, DSP received expanded marketing approval to include treatment of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.
"This licensing agreement with DSP provides Chelsea with exclusive access
to a substantial body of clinical safety and efficacy data believed to be applicable
to both the U.S. and E.U. regulatory approval," said Simon Pedder, Chelsea's
president and CEO.