Emergent BioSolutions Receives Orphan Drug Designation for Its TRU-016 Protein Therapeutic for the Treatment of Chronic Lymphocytic Leukemia

Emergent BioSolutions Inc. (NYSE: EBS) announced today that its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, in development for the treatment of B-cell malignancies has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of chronic lymphocytic leukemia patients. This designation is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S. TRU-016 is being developed in collaboration with Abbott.

“Receiving FDA Orphan Drug Designation for TRU-016 underscores the medical need in treating B-cell malignancies like CLL,” said Scott C. Stromatt, M.D., Senior Vice President and Chief Medical Officer, Emergent BioSolutions. “Emergent is pleased to receive this designation and is committed to advancing product candidates that improve the lives of patients suffering from diseases like CLL.”

The FDA Orphan Drug Designation of TRU-016 provides for a number of potential benefits, including a seven-year period of marketing exclusivity in the U.S., reduced or waved regulatory fees, certain tax credits, and additional regulatory assistance and access to specific grants programs for research and development initiatives.