Chelsea Therapeutics International has initiated a development program and signed a letter of intent to acquire all intellectual property rights previously belonging to Synergia Pharma for L-Threo DOPS (L-DOPS or Droxidopa), a synthetic amino acid currently approved and marketed in Japan for the treatment of neurogenic orthostatic hypotension.

Chelsea intends to seek Orphan Drug Status for Droxidopa from the FDA and European Health Agencies for the treatment of neurogenic orthostatic hypotension. Orphan Drug Status, granted for rare diseases afflicting less than 200,000 patients per year in the United States and similar population in Europe, should provide Chelsea with considerable strategic advantages for accelerating the development of Droxidopa by reducing clinical development costs, facilitating global regulatory filings and providing 7 years of marketing exclusivity in the United States and 10 years in the European Union.

"Development of Droxidopa provides a unique opportunity to accelerate Chelsea's drug development activities, expand our product pipeline and help finance the establishment of a sales and marketing infrastructure prior to commercialization of our lead compound, CH-1504," commented Dr. Simon Pedder, Chelsea's president and CEO. "Given the accumulated evidence of its clinical efficacy and safety, its potential for rapid development and the significant unmet need in its therapeutic indications, we believe Droxidopa represents an attractive commercialization opportunity in the global markets." he added.

Droxidopa initially received Japanese 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.

Early clinical data suggests that Chelsea's lead product candidate, CH-1504, may support a safe and effective treatment for rheumatoid arthritis and may have further applications for psoriasis, certain cancers and other immunological disorders.