Safety Monitoring Committee Recommends That Emergent BioSolutions Continue Its Hepatitis...

Wed Jan 9, 2008 7:00am EST
 
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Safety Monitoring Committee Recommends That Emergent BioSolutions Continue Its Hepatitis B Immunotherapy Phase II Trial

ROCKVILLE, Md.--(Business Wire)--Emergent BioSolutions Inc. (NYSE: EBS) announced today that based
upon recommendations from an independent Safety Monitoring Committee
(SMC) the company is progressing into the next stage of the enrollment
of patients in its study of a hepatitis B immunotherapy. In this
study, a total of 45 patients with chronic hepatitis B virus (HBV)
infection are being randomized within three separate groups to receive
immunotherapy or placebo. The immunotherapy utilizes the company's
proprietary spi-VEC delivery system to deliver the hepatitis B core
antigen, in order to induce an immune response to the hepatitis B
virus.

   "We are pleased by the Safety Monitoring Committee's
recommendation and look forward to advancing this critical study of
our hepatitis B candidate. Hepatitis B is the tenth leading cause of
death worldwide and our commitment to the development of this
therapeutic vaccine is squarely in line with our mission - to protect
life," said Daniel Abdun-Nabi, president of Emergent BioSolutions Inc.

   The SMC reviewed the safety data from the first group of patients
that have completed day 70 in the study. On the basis of the available
data, the SMC recommended that the company continue to progress the
study into the two remaining groups. The company anticipates
preliminary top line safety and efficacy data from this study will be
available at the end of 2008 and complete study results will be
available in the first half of 2009.

   About The Hepatitis B Therapeutic Vaccine Candidate

   Although current treatment options are safe and effective in the
majority of patients, the majority of hepatitis B patients are unable
to clear the viral infection resulting in the need for long-term
therapy. The company's HBV immunotherapeutic is designed to direct the
immune system against virus infected cells in the liver. Following
oral administration, the hepatitis B core antigen protein is produced
by the spi-VEC Salmonella vector, within gut macrophages. The
macrophages "present" portions of the HBV core antigen to the immune
system, inducing antigen specific T-cells responsible for
cell-mediated immunity. Through the targeted immune response, the
company's hepatitis B immunotherapy is anticipated to benefit patients
by increasing the potential to clear the virus therefore minimizing
the risk of liver damage and eliminating the need for long-term
antiviral therapy.

   About Hepatitis B

   The World Health Organization (WHO) estimates that up to 2 billion
people (one-third of the world's population) have been infected with
HBV and that between 350 and 400 million people are chronically
infected. Globally, chronic HBV is one of the leading causes of
advanced liver cancer. During their lifetime, 10-40% of chronic HBV
patients will develop serious sequelae, such as hepatocellular
carcinoma, cirrhosis and decompensated liver disease. Hepatitis B
virus affects all countries and geographic areas throughout the world.

   The hepatitis B market size is estimated to be currently valued at
$500 million and is expected to double to over $1 billion by 2010. The
strong market growth is attributed to an increase in the awareness and
diagnosis of hepatitis B, as well as the increasing use of drug
combination therapy.

   About Emergent BioSolutions Inc.

   Emergent BioSolutions Inc. is a profitable, multinational
biopharmaceutical company dedicated to one simple mission--to protect
life. We develop, manufacture and commercialize immunobiotics,
consisting of vaccines and therapeutics, that assist the body's immune
system to prevent or treat disease. Our products target infectious
diseases and other medical conditions that have resulted in
significant unmet or underserved public health needs. Our marketed
product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine
approved by the U.S. Food and Drug Administration for the prevention
of anthrax infection. More information on the company is available at
www.emergentbiosolutions.com.

   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, including clinical trial results and
development plans, 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 rate and degree of market acceptance and
clinical utility of our products; our ongoing and planned development
programs, preclinical studies and clinical trials; our ability to
identify and acquire or in license products and product candidates
that satisfy our selection criteria; the potential benefits of our
existing collaboration agreements and our ability to enter into
selective additional collaboration arrangements; the timing of and our
ability to obtain and maintain regulatory approvals for our product
candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our intellectual property portfolio; 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, 2007 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.

Emergent BioSolutions Inc.
Investors:
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt, 301-795-1847
Director, Corporate Communications
SchmittT@ebsi.com

Copyright Business Wire 2008

 

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