Emergent BioSolutions Inc. (NYSE:EBS) announced today that it was
awarded a cooperative agreement from the National Institute of Allergy
and Infectious Diseases (NIAID), part of the National Institutes of
Health, to further the development of one of Emergent’s advanced anthrax
vaccine candidates known as dmPA7909. The novel vaccine candidate is
designed to have characteristics that will make it ideal to meet the
U.S. government’s needs for an advanced anthrax vaccine such as the
potential to confer a rapid immune response following only two doses,
long-term stability to enable ambient storage in the Strategic National
Stockpile, and the potential to be distributed in a national emergency
without the need for cold chain storage conditions.
"We are excited about receiving NIAID funding support for dmPA7909, one
of Emergent’s next generation anthrax vaccine candidates in
development,” said W. James Jackson, Ph. D., senior vice president and
chief scientific officer of Emergent BioSolutions. "We look forward to
advancing dmPA7909, along with our other vaccine and therapeutic
candidates in our anthrax program, as we continue to support the U.S.
government’s approach of funding the development of multiple medical
countermeasures against the threat of bioterrorism.”
The anthrax vaccine candidate is composed of the double-mutant
recombinant protective antigen (dmPA), which has been genetically
engineered for improved stability. dmPA is adsorbed to Alhydrogel®,
combined with the immunostimulatory compound CPG 7909 (VaxImmune TM)
and formulated as a dry powder. Emergent is employing proven stabilizing
technologies for each of the components in the vaccine formulation to
seek to maximize vaccine stability even at elevated temperatures and to
extend shelf life.
This funding in the amount of $4.9 million over a two-year period
provides for manufacturing of clinical lots, non-clinical safety and
efficacy studies, and stability studies to demonstrate whether the
vaccine candidate can withstand high temperatures up to 37oC.
The cooperative agreement is funded through the American Recovery and
Reinvestment Act of 2009 (ARRA), which was signed into law on February
17 to stimulate the growth and recovery of the U.S. economy.
About Emergent’s Anthrax Program
Emergent’s anthrax program consists of a licensed vaccine and several
novel vaccines and immune-related therapeutics in development:
-
BioThrax® (Anthrax Vaccine Adsorbed) -
the only vaccine licensed by the FDA for the prevention of anthrax
infection. Since 1998, the U.S. government has procured nearly 34.5
million doses of BioThrax. During that time period, nearly 8.7 million
doses have been administered to more than 2.2 million military
personnel.
-
rPA Anthrax Vaccine - a recombinant anthrax vaccine candidate,
which is composed of a purified protective antigen protein adsorbed to
an aluminum adjuvant and is designed to induce antibodies that
neutralize anthrax toxins.
-
Advanced Anthrax Vaccine
(dmPA7909) – a recombinant
anthrax vaccine candidate, which is composed of the double-mutant
protective antigen, licensed from NIAID, adsorbed to Alhydrogel®,
combined with the immunostimulatory compound CPG 7909 (VaxImmuneTM),
licensed from Pfizer, Inc., and formulated as a dry powder.
-
Advanced Anthrax Vaccine
(AV7909) - an anthrax vaccine
candidate based on BioThrax combined with the immunostimulatory
compound CPG 7909 (VaxImmuneTM), licensed from Pfizer, Inc.
We are anticipating this candidate will have advanced characteristics,
including one or more of the following: reduced number of doses,
enhanced immune response, longer expiry dating or a novel delivery
method.
-
Anthrax Immune Globulin Therapeutic (AIG) - a polyclonal
anthrax immune globulin candidate being developed as an intravenous
post-exposure treatment for patients who present with symptoms of
anthrax disease. AIG is derived from human plasma from individuals who
have been vaccinated with BioThrax.
-
Anthrax Monoclonal Antibody Therapeutic – a fully human anthrax
monoclonal antibody candidate also being developed as an intravenous
post-exposure therapy for individuals who have symptoms of anthrax
disease. Based on pre-clinical animal studies, this monoclonal
antibody appears to be a highly active therapeutic.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of vaccines and
therapeutics that assist the body’s immune system to prevent or treat
disease. Emergent’s marketed product, BioThrax® (Anthrax
Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and
Drug Administration for the prevention of anthrax disease. Emergent’s
development pipeline includes programs focused on anthrax, botulism,
tuberculosis, typhoid, hepatitis B and chlamydia. Additional information
may be found at www.emergentbiosolutions.com
and www.biothrax.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 any potential future securities
offering, our expected revenue growth and net earnings for 2009, 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 ability to
obtain additional development funding for our product candidates; the
rate and degree of market acceptance and clinical utility of our
products; the success of our ongoing and planned development programs,
preclinical studies and clinical trials; the timing of and our ability
to obtain and maintain regulatory approvals for our other product
candidates; our ability to obtain sales contracts for products; 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 June 30, 2009 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.
