ROCKVILLE, Md.–(BUSINESS WIRE)–Mar. 22, 2012– Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has received a multi-year grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to advance the development of MVA85A, a candidate vaccine against tuberculosis (TB). The vaccine is being developed through a partnership between Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC), a joint venture between Emergent and the University of Oxford, where the vaccine was originally developed and investigated.
MVA85A is now completing a Phase 2b clinical trial sponsored by Aeras to evaluate the safety and efficacy of the vaccine in over 2,700 infants in South Africa. Results from this trial, which has received continued funding from Aeras and the Wellcome Trust, are anticipated later this year. MVA85A is also currently being studied in a second Phase 2b clinical trial, with primary funding and support from the European and Developing Countries Clinical Trials Partnership and Aeras, which will enroll approximately 1,400 adults living with the human immunodeficiency virus (HIV) in Senegal and South Africa.
“Emergent is honored to gain NIAID support, expanding the current government and non-government partners that are joining forces to advance this vaccine candidate. We all share a vision to declare victory in the global fight against tuberculosis and Emergent is proud to be at the forefront with such distinguished organizations,” said Daniel J. Abdun-Nabi, President and Chief Operating Officer of Emergent BioSolutions. “With efficacy data expected in the coming months, we are hopeful that MVA85A will have a significant impact on the global burden of this highly contagious and lethal disease.”
According to the World Health Organization, approximately 1.5 million people die from tuberculosis annually, and more than two billion people are infected with TB – an estimated one out of every three people on the planet. It is the second leading cause of death from infectious disease worldwide. The limited efficacy against pulmonary TB of the only available licensed TB vaccine, BacilleCalmette-Guerin (BCG), and the rise of multi-drug and extensively-drug resistant TB cases, demonstrate the need for improved control measures against TB.
“We join the rest of the world in observing World TB Day on March 24, commemorating the discovery of the cause of the disease, the TB bacillus, that paved the way for the development of TB treatments, diagnostics, and vaccines,” said Dr. Jacqui Shea, General Manager of OETC. “Through much appreciated and essential grant funding, product development partnerships are making significant steps forward to stop TB. With continued support and collaboration, we hope to achieve our shared goal of a world free of TB within our lifetime.”
About Emergent BioSolutions Inc.
Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.
About MVA85A
The MVA85A vaccine candidate is intended to boost the response of T-cells already stimulated by the BCG vaccine. The vaccine candidate was originally developed at the University of Oxford by Professor Helen McShane, a professor of vaccinology and Wellcome Trust Senior Fellow, working with Dr. Sarah Gilbert, a Reader in Vaccinology, and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow. It was licensed to theOxford-Emergent Tuberculosis Consortium by Isis Innovation, the University’s technology transfer company, inJuly 2008. Previous clinical trials of the vaccine in adults – supported by the Wellcome Trust – in the United Kingdom, the Gambia, Senegal and South Africa have demonstrated consistently high cellular immune responses in those who received the MVA85A vaccine candidate following vaccination with BCG. To date, the vaccine has been shown to have an acceptable safety profile. The vaccine has been awarded orphan drug status by theEuropean Medicines Agency (EMA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.
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 strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, 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 actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain additional funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent’s Annual Report on Form 10-K for the year ended December 31, 2011 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim 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.
Emergent BioSolutions Inc.
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Published Date : March 22, 2012
