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news.The US Patent and Trademark Office (USPTO) has granted notices of allowance (NOA) for Raptor Pharmaceutical's two patent applications regarding its delayed-release oral formulation of cysteamine bitartrate (DR Cysteamine).
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NOA also includes other formulations of cystamine and cysteamine.
The patent application 11/990,869 covers the use of any composition of cysteamine or cystamine that provides increased delivery to the small intestine with pharmacokinetic benefits that allow for less than 4 times daily dosing.
Another patent application12/745,504 covers the use of cysteamine or cystamine, in any formulation, for the treatment of Non-alcoholic Steatohepatitis (NASH).
Raptor holds licenses to these patent applications, which are owned by the Regents of the University of California, and are based on work performed at the University of California, San Diego (UCSD).
Raptor CEO Christopher Starr said in addition to the market exclusivity they may receive in the US and the EU for their orphan designated programs, they believe that the claims in these patent applications will provide additional market protection for expanding portfolio of orphan and non-orphan cysteamine clinical indications.
DR Cysteamine’s data analysis is underway for the Phase 3 clinical trial in patients with nephropathic cystinosis and expects to report data by the end of July 2011.
Raptor is also investigating DR Cysteamine’s potential to treat neurodegenerative diseases.
The company is collaborating with CHU d’Angers on a Phase 2/3 clinical trial of DR Cysteamine in Huntington’s Disease, a rare, inherited neurological disorder.