Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine technology company, and subsidiary of Emmaus Life Sciences, Inc., today announced that the European Commission (EC) has granted Orphan Medicinal Product designation for the company's investigational drug Levoglutamide (L-glutamine) for the treatment of sickle cell disease. The EC designation follows the recommendation of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products announced in May.
Sickle cell disease affects approximately 2.5 in 10,000 people in the European Union, according to studies filed with EMA. However, in some European countries, the concentration of those suffering from sickle cell disease is higher as a result of demographics, migration and geographic mobility, surpassing genetic disorders such as hemophilia and cystic fibrosis, according to a study in the Hematology Journal.
"The positive decision by the European Commission paves the way for us to provide accessible treatment to people throughout Europe who suffer from this debilitating disease," said Yutaka Niihara, M.D., MPH, founder and CEO of Emmaus. "Throughout the world a new treatment option for sickle cell disease is urgently needed, and we are committed to bringing a treatment to market for this severely underserved patient population."
Emmaus said it currently is conducting a clinical trial that is in Phase III with the U.S. Food and Drug Administration (FDA) to study L-glutamine as a treatment for sickle cell disease. Research is being conducted at over 30 clinical trial sites around the country with over 175 people presently enrolled. The company anticipates total enrollment of more than 200 and aims to complete the trial in 2013.
"We are pleased to have received this important designation, which provides for marketing exclusivity 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.
SOURCE Emmaus Medical, Inc.