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European Commission Grants Orphan Medicinal Product Designation for Emmaus Medical's Sickle Cell Treatment
Date:7/17/2012

lusivity in the region and further enhances our efforts to team with a strategic partner, both in Europe and in other key regions," added Henry McKinnell, Ph.D., Chairman of the Board of Emmaus Life Sciences, Inc. and former CEO of Pfizer, Inc.

The patent protected treatment, whose research was led by Dr. Niihara and investigators at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, has both an orphan drug designation and fast track status in the United States.

For more information about the clinical trial, please visit the Emmaus Medical website at www.emmausmedical.com or www.clinicaltrials.gov (NCT01179217).

About Orphan Drug Status in the European Union
The EMA grants orphan drug status for products that can be used in the diagnosis, treatment, or prevention of life-threatening or chronically debilitating conditions with an incidence rate of no greater than 5 in 10,000 individuals in the European Union. Orphan status is conferred when either no satisfactory method of diagnosis, prevention or treatment of the authorized condition exists, or, if such a method does exist, the treatment must be of significant benefit to patients affected by the condition. Orphan status allows the company 10 years of marketing exclusivity in all EU member countries after approval, and other benefits during the development and regulatory review process including scientific assistance for study protocols, access to a centralized review process covering all EU member countries, and reduced or waived registration and marketing authorization application fees.

About Sickle Cell Disease
Sickle cell disease is an inherited blood disorder causing red blood cells to become oxidized, forming rigid and sickle shaped cells that block s
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SOURCE Emmaus Medical, Inc.
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