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 twitter: @emergentbiosolu.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2012, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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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