Chelsea Therapeutics International, Ltd., a biopharmaceutical developing company that acquires and develops innovative products for treatment of a variety of human diseases, has received a notice of allowance from the US Patent & Trademark Office (USPTO) for its patent application "Threo-DOPS controlled release formulation," US patent application number 11/698,974. Upon issuance, the patent will expire no earlier than 2026.
The newly allowed claims relate to certain oral, controlled release formulations of Northera (droxidopa) that include an extended release component and an immediate release component. The patent will establish protection for a once-a-day Northera beyond the seven-year marketing exclusivity afforded by its orphan designation in the US, enabling Chelsea to pursue the therapeutic development of Northera in indications expected to benefit from a controlled release formulation.
"This patent allowance notice from the USPTO provides key support for the intellectual property protection we are building for Northera," said Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "This latest patent could provide significant growth opportunities for Chelsea, as we investigate additional, potential therapeutic applications of Northera which is currently under review at the FDA for the treatment of symptomatic, neurogenic orthostatic hypotension and has a PDUFA date of March 28, 2012."
This notice of allowance marks the second major milestone for the Company's intellectual property pursuits this year. In August 2011, the United States Patent and Trademark Office issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia.
Northera (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, has been studied in two Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa previously demonstrated clinical benefits in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder in Phase II trials and is currently being evaluated in an ongoing Phase II trial for the treatment of fibromyalgia.