The European Medicines Agency as granted Raptor Pharmaceutical orphan medicinal product designation for DR Cysteamine to treat cystinosis, a genetic condition that affects the kidney.
The designation gives Raptor Pharmaceutical ten years of market exclusivity for DR Cysteamine in the EU once the drug is approved.
Raptor Pharmaceutical said that a Phase IIb study of the drug showed improved tolerability and the potential to reduce total daily dosage and administration frequency compared with cysteamine bitartrate, the current standard of care for cystinosis.
Raptor also said it would begin the Phase III clinical trial of the drug in cystinosis patients in the second quarter of 2010.
The orphan medicinal product designation is granted to advance the production of drugs to treat, prevent or diagnose life-threatening conditions in the EU.
The designation provides special benefits, including research support, eligibility for protocol assistance, and reductions in certain regulatory fees during development.
