Raptor Pharmaceutical Corp. (Raptor) announced that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for two patents covering the company's delayed-release oral formulation of cysteamine bitartrate (DR Cysteamine), as well as other formulations of cystamine and cysteamine.

Raptor holds exclusive, worldwide 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). Both patent applications are expected to issue before the end of 2011.

"In addition to the market exclusivity we may receive in the US and the European Union for our orphan designated programs, we believe that the claims in these patent applications will provide significant additional market protection for our expanding portfolio of orphan and non-orphan cysteamine clinical indications," commented Christopher M. Starr, Ph.D., CEO of Raptor. "These allowances testify to the innovative and novel work performed by the medical researchers at UCSD, who had the scientific vision and dedication to the cystinosis patient community to perform the pivotal proof-of-concept work that we believe will lead us to an improved therapy for nephropathic cystinosis and support our expanding list of additional indications."

Patent application 11/990,869 covers the use of any composition of cysteamine or cystamine, regardless of the specific formulation, that provides increased delivery to the small intestine with pharmacokinetic benefits that allow for less than 4 times daily dosing. The company believes that its proprietary formulation of cyteamine may provide significant therapeutic and compliance advantages compared to the presently marketed, immediate-release cysteamine bitartrate for the treatment of nephropathic cystinosis. Data analysis is underway for the Phase 3 clinical trial of DR Cysteamine in patients with nephropathic cystinosis following the completion of the last patient visit in early June 2011. The company expects to report top-line data from this clinical trial by the end of July 2011.

Patent application 12/745,504 covers the use of cysteamine or cystamine, in any formulation, for the treatment of Non-alcoholic Steatohepatitis (NASH). In 2010, the company released results of its phase 2a clinical trial of a prototype formulation of DR Cysteamine in NASH, which was conducted in collaboration with UCSD. Raptor plans to test a solid caplet formulation of DR Cysteamine in a phase 2b clinical trial in NASH in 2012.

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. In addition to claims related to the treatment of neurodegenerative diseases in UCSD patent application 11/990,869, the Company holds an exclusive worldwide license to two issued patents related to the treatment of a variety of neurodegenerative diseases, including Huntington's Disease, from the Weizmann Institute of Science in Israel and the Niigata University in Japan.

DR Cysteamine is Raptor's proprietary enteric-coated, microbead oral formulation of cysteamine bitartrate designed to reduce dosing frequency and reduce gastrointestinal side effects associated with immediate-release cysteamine bitartrate, which is approved for sale by the US Food and Drug Administration and the European Medicines Agency to treat nephropathic cystinosis.

In December 2007, Raptor obtained an exclusive, worldwide license from the University of California, San Diego for the development DR Cysteamine for nephropathic cystinosis and cysteamine for other potential indications including Huntington's Disease and NASH.

Raptor Pharmaceutical Corp.(Raptor) is dedicated to speeding the delivery of new treatment options to patients by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise.