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NIAID to Fund Development of Emergent BioSolutions’ Advanced Anthrax Vaccine Candidate

ROCKVILLE, Md.–(BUSINESS WIRE)–Sep. 30, 2009– 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 37^oC.

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 (VaxImmune^TM), 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 (VaxImmune^TM), 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.

 

 

Source: Emergent BioSolutions Inc.