Emergent BioSolutions to Expand Front Line CLL Clinical Trial of TRU-016 and Rituximab Based on Strong Patient Enrollment and

  Emergent BioSolutions to Expand Front Line CLL Clinical Trial of TRU-016 and
  Rituximab Based on Strong Patient Enrollment and Encouraging Early Clinical
  Data

Business Wire

ROCKVILLE, Md. -- April 05, 2013

Emergent BioSolutions Inc. (NYSE: EBS) today announced its decision to expand
the protocol for its ongoing Phase 1b, single arm, open label study (Protocol
16009) evaluating the safety and efficacy of TRU-016 in combination with
rituximab in previously untreated patients with chronic lymphocytic leukemia
(CLL).The expanded protocol will include two new study cohorts to examine a
lower dose of TRU-016 with rituximab in front line CLL and to evaluate the
combination in relapsed CLL patients. This decision is based on strong patient
enrollment along with encouraging early safety and efficacy data from this
study.TRU-016 is the company’s humanized anti-CD37 monospecific protein
therapeutic, built on its ADAPTIR^TM (Modular Protein Technology) platform,
for the treatment of CLL.

“Emergent is pleased with the progress of our Phase 1b study of TRU-016 in
combination with rituximab in front line patients with CLL.The strong
enrollment and the encouraging early data from this open label study are
expected to facilitate an expanded clinical trial program that would further
support the start of Phase 3 clinical trials for TRU-016 in 2014,” said Scott
C. Stromatt, M.D., senior vice president and chief medical officer of Emergent
BioSolutions. “We thank our investigators and all of the patients for the
progress thus far and look forward to presenting data later this year.”

The company anticipates that this expanded clinical program will significantly
enhance the value of TRU-016 and the company’s active partnering program
without impacting the company’s total 2013 operating expenses.

Update on TRU-016 in Combination with Bendamustine (Protocol 16201)

TRU-016 is also currently being evaluated in a randomized, open label,
active-controlled Phase 2 study in combination with bendamustine in patients
with relapsed CLL. This study is on track to achieve its target enrollment of
approximately 60 patients in April 2013. The primary outcome measurement for
this study is overall response rate. Results from the Phase 1b portion of this
study, presented at the American Society of Hematology annual meeting on
December 8, 2012, indicated that TRU-016 in combination with bendamustine was
well tolerated and showed an NCI overall response rate of 83% with a CR rate
of 33% (n=12). “Data from the combination study with bendamustine are very
encouraging,” said Dr. Stromatt. “TRU-016 is a unique molecule with a novel
target that has shown additive and/or synergistic efficacy in animal models
when used in combination with several therapeutic agents used to treat CLL,
such as rituximab, ofatumumab, mTOR inhibitor, bendamustine, and PI3K
inhibitors.”

Data from both TRU-016 clinical trials are expected to be available in the
second half of 2013. TRU-016 has received Orphan Drug status from the FDA and
Orphan Medicinal Product Designation from the European Commission for the
treatment of CLL.

About the ADAPTIR™ Platform

ADAPTIR monospecific proteins are single chain polypeptides that comprise
three components: a binding domain (VL and VH), a hinge domain, and an
effector domain (huFc). They have a differentiated structure from monoclonal
antibodies and can generate a unique signaling response. In addition, ADAPTIR
proteins may mediate complement dependent cytotoxicity and Fc dependent
cytotoxicity, similar to monoclonal antibodies.

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, prospects, plans and objectives of management,
and any other statements containing the words “believes”, “expects”,
“anticipates”, “intends”, “plans”, “estimates” and similar expressions, are
forward-looking statements. Forward-looking statements in this press release
include statements about the possible start of Phase 3 clinical trials of
TRU-016, the encouraging data from the Phase 1b study, enrollment in the Phase
2 study (Protocol 16201), and the availability of data from our clinical
trials. These forward-looking statements are based on our current intentions,
beliefs and expectations regarding future events. We cannot guarantee that any
forward-looking statement will be accurate. Investors should realize that if
underlying assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could differ materially from our expectations.
Investors are, therefore, cautioned not to place undue reliance on any
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There are a number of important factors that could cause the company’s actual
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factors that could cause actual results to differ from our expectations in any
forward-looking statement. Investors should consider this cautionary
statement, as well as the risk factors identified in our periodic reports
filed with the SEC, when evaluating our forward-looking statements.

Contact:

Emergent BioSolutions Inc.
Investors:
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
Media:
Tracey Schmitt, 301-795-1800
Vice President, Corporate Communications
SchmittT@ebsi.com
 
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