Emergent BioSolutions Inc. (NYSE: EBS) today announced that the European Commission granted orphan medicinal product designation to Emergent’s humanized single chain monoclonal antibody against CD37, also called TRU-016, for the treatment of chronic lymphocytic leukemia (CLL).
“Receiving orphan medicinal product designation for TRU-016 from the European Commission, following orphan drug designation from the FDA in 2011, is an important step in the development of TRU-016 and underscores the medical need in treating B-cell malignancies like CLL,” said Scott C. Stromatt, M.D., senior vice president and chief medical officer of Emergent BioSolutions. “Emergent is pleased to receive these designations and we are looking forward to data from our ongoing CLL studies.”
Orphan designation of TRU-016 for CLL in Europe qualifies it for certain development and commercial incentives, including protocol assistance, access to centralized authorization procedures, reduced fees for regulatory activities, and ten years of market exclusivity after approval. In December 2011, Emergent announced that the United States Food and Drug Administration granted orphan drug designation to TRU-016 for the treatment of CLL.
TRU-016 is currently being evaluated in a randomized Phase 2 study (16201) in combination with bendamustine compared to bendamustine alone in relapsed CLL patients. The primary outcome measurement for this study is overall response rate and data are expected in the second half of 2013.
Data from the Phase 1b portion of the study (16201) were presented at the American Society of Hematology annual meeting on December 8, 2012. Results from this study indicated that TRU-016 in combination with bendamustine was well tolerated and showed a positive response.
In addition, the company initiated in November 2012 a Phase 1b, single-arm, open label study (16009) evaluating TRU-016 in combination with rituximab in previously untreated patients. The primary outcome measurement for this study is overall response rate and data are expected in the second half of 2013.