Emergent’s TRU-016 for CLL Receives Orphan Medicinal Product Designation
from European Commission
ROCKVILLE, Md. -- January 2, 2013
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.
About Emergent BioSolutions
Emergent BioSolutions is a specialty pharmaceutical company seeking to protect
and enhance life by offering specialized products to healthcare providers and
governments to address medical needs and emerging health threats. Additional
information may be found at www.emergentbiosolutions.com. Follow us on
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Emergent BioSolutions Inc.
Robert G. Burrows, 301-795-1877 (Investor)
Vice President, Investor Relations
Tracey Schmitt, 301-795-1800 (Media)
Vice President, Corporate Communications
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