Chelsea Therapeutics acquires intellectual property of Synergia, seeks orphan drug status for L-Threo

By Lisa Kerner

Erie, Pa., May 8 - Chelsea Therapeutics International, Ltd. began 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 approved and marketed in Japan for the treatment of neurogenic orthostatic hypotension.

The company plans to seek orphan drug status for Droxidopa from the Food and Drug Administration 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 seven 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 Simon Pedder, Chelsea's president and chief executive officer, in a news release.

"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."

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.

In 2000, Droxidopa received expanded marketing approval to include treatment of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients. Droxidopa currently generates annual revenue of about $50 million in Japan.

Chronic, symptomatic orthostatic hypotension is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in sudden, decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope.

Droxidopa, an orally active synthetic precursor of norepinephrine, increases the supply of norepinephrine available for delivery to its receptors to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.

An estimated 100,000 U.S. patients suffer from chronic, symptomatic orthostatic hypotension, which is commonly associated with Parkinson's disease, Pure Autonomic Failure and Multiple System Atrophy, which encompasses disorders previously known as striatonigral degeneration, olivoponto-cerebellar atrophy and the Shy-Drager syndrome.

Located in Charlotte, N.C., Chelsea is a biopharmaceutical development company that acquires and develops products to treat human diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.