Raptor Pharmaceutical Corp awarded US orphan drug exclusivity for PROCYSBI for nephropathic cystinosis.
M2 EQUITYBITES-June 26, 2013-Raptor Pharmaceutical Corp awarded US orphan drug exclusivity for PROCYSBI for nephropathic cystinosis(C)2013 M2 COMMUNICATIONS http://www.m2.com
Biotechnology company Raptor Pharmaceutical Corp (NasdaqGM:RPTP) reported on Tuesday that it has received orphan drug exclusivity for PROCYSBI (cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis in patients age six and older.
This orphan drug exclusivity was awarded by the Office of Orphan Product Development at the Food and Drug Administration (FDA).
The company added the exclusivity period began on the date of FDA approval, 30 April 2013, and lasts seven years subject to certain exceptions.
According to the company, it provides individual services to help patients access PROCYSBI through education, support and extensive case management.
Nephropathic cystinosis reportedly comprises 95% of cases of cystinosis, a rare, life-threatening metabolic lysosomal storage disorder that causes toxic accumulation of cystine in all cells, tissues, and organs in the body, leading to progressive, irreversible tissue damage and multi-organ failure, including kidney failure, blindness, muscle wasting and premature death.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jun 26, 2013|
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