- Study designed to confirm safety and immunogenicity of vaccine
manufactured at the large-scale commercial facility planned
for launch
- Phase III trials are expected to begin next year
ROCKVILLE, Md.--(BUSINESS WIRE)--June 5, 2008--Emergent
BioSolutions Inc. (NYSE:EBS) announced today that dosing of patients
has begun in a U.S. Phase II clinical trial of the company's
single-dose oral typhoid vaccine candidate. This randomized,
double-blind, placebo-controlled, single-dose, dose-escalation trial
is being conducted in healthy adults. The company anticipates that
trial results will be available by year end. This US study will
evaluate vaccine manufactured at the large-scale facility planned for
commercial launch. This trial is designed to confirm the safety and
immunogenicity of the vaccine, and Phase III trials are expected to
begin in 2009. If approved, this candidate would be the first
single-dose, drinkable typhoid vaccine available for adults and
children.
"The commencement of this U.S. Phase II study represents an
important milestone in the clinical development of our oral typhoid
vaccine candidate," said Daniel Abdun-Nabi, president and chief
operating officer of Emergent BioSolutions. "In previous clinical
studies, this vaccine candidate has demonstrated promising
immunogenicity and safety results in both children and adults. We are
pleased with our continued progress in the development of this
important vaccine candidate, which is a cornerstone in our company's
mission of protecting life."
Dr. Stephen Lockhart, senior vice president of product development
for Emergent BioSolutions, said, "Typhoid fever continues to be a high
disease burden worldwide, claiming over 200,000 lives annually, most
notably children living in developing countries where the disease is
endemic. In addition, there is increasing incidence of antibiotic
resistant strains of the disease which would suggest an even greater
need for efficient and effective vaccination. This global health
problem affects not only individuals living in endemic regions but
also those traveling to typhoid endemic regions. With millions of
people traveling globally every year, typhoid fever remains a health
concern in industrialized and developing countries. This clinical
trial is an important next step in the development of this advanced
stage product."
About the Typhoid Vaccine Candidate
The company's typhoid vaccine candidate is a live, attenuated
strain of Salmonella typhi engineered to eliminate virulence by
deletion of two specific genes. The vaccine is intended to be
administered in a single, drinkable dose for adults and children
residing in typhoid endemic regions as well as individuals traveling
to these endemic regions. Currently available typhoid vaccines have
limited efficacy in children less than six years of age. In endemic
regions, pre-school aged children have the greatest public health risk
for contracting typhoid fever. Emergent's typhoid development program
is focused on developing a product that is safe and effective with a
patient friendly method of administration, as well as serving a
critical unmet need in targeting a product that would be effective in
children as young as two.
Previously published studies have shown the vaccine candidate to
be immunogenic and well-tolerated in both adults and children as young
as 5 years of age. The vaccine candidate has completed various trials,
including:
- A randomized, placebo-controlled Phase II clinical study
conducted among children in Vietnam. Study results showed that
97% of the children administered a single, oral dose of
vaccine developed an immune response, defined as an increase
in Salmonella typhi anti-LPS IgG and/or IgA antibody levels in
the blood. No serious adverse events were reported.
- An open-label, non-placebo controlled, pilot study conducted
in the United Kingdom in healthy adults in which the vaccine
candidate was well tolerated and immunogenic, eliciting both
cell mediated and humoral responses.
- A double-blind, placebo controlled, single-dose, dose
escalating clinical trial conducted in the United States in
which 100% of the trial participants in the highest dose group
and 56% of the participants in the lowest dose group developed
an immune response.
- An open-label, non-placebo controlled, single-dose clinical
trial conducted in the United States in healthy adults to
evaluate the safety and immunogenicity of two different
presentations of the vaccine. The vaccine candidate was
similarly immunogenic in both presentations and both were well
tolerated.
- A single-blind, placebo controlled clinical trial in Vietnam
in healthy adults. The Wellcome Trust provided funding for the
trial. The vaccine met the criterion for immunogenicity and
was well tolerated, with no serious adverse events reported.
For the current clinical study, approximately 200 patients will be
enrolled across three sites in the U.S. Screening of patients for this
study began in early May 2008. Further information on this trial is
available on www.clinicaltrials.gov and can be referenced under the
trial code NCT00679172.
Additional trials are being designed that would address the needs
of adults, children and seniors residing in and traveling to typhoid
endemic regions. Emergent is working closely with regulatory agencies
in the U.S., Europe and endemic regions to design a development
program that meets disease prevention needs and builds upon current
disease management programs.
About Typhoid
Typhoid, also known as typhoid fever, is caused by infection with
the bacterium Salmonella typhi. Typhoid is characterized by fever,
headache, constipation, malaise, stomach pains, anorexia and myalgia.
Severe cases of typhoid can result in confusion, delirium, intestinal
perforation and death. Typhoid is transmitted by consuming
contaminated food or drinks. Contamination usually results from poor
hygiene and sanitation. Typhoid is often endemic in developing
countries in which there is limited access to treated water supplies
and sanitation.
An estimated 22 million cases of typhoid occur every year
worldwide. The World Health Organization (WHO) recommends that
pre-school aged children living in typhoid endemic regions be
immunized to control the disease. In addition, typhoid fever
vaccination should be considered for all persons traveling to
developing countries, with travelers to Asia, Africa and Latin America
deemed to be especially at risk. U.S. military personnel deployed in
these areas are also at risk of infection.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company
dedicated to one simple mission--to protect life. We develop,
manufacture and commercialize 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, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including our expected revenue growth and
net earnings for 2008, 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 our ongoing and planned development programs,
preclinical studies and clinical trials; our plans to expand our
manufacturing facilities and capabilities; the rate and degree of
market acceptance and clinical utility of our products; 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 other
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 current report on Form 10-Q for the quarter ended March 31,
2008 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.
CONTACT: Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Director, Corporate Communications
301-795-1800
SchmittT@ebsi.com
SOURCE: Emergent BioSolutions Inc.
|