El-Hibri Fuad Blog

Posts Tagged ‘National Institute of Allergy and Infectious Diseases

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.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com

Published Date : March 22, 2012

ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. The product candidate, a third generation vaccine being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909.

“Emergent is pleased to commence this clinical trial in support of the U.S. government’s multiple product strategy to strengthen the nation’s biodefense capabilities,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe this third generation anthrax vaccine has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response, and having a favorable shelf life. If successful, this could be an attractive candidate for the government’s growing arsenal of medical countermeasures.”

The Phase I clinical trial, a parallel arm dose-ranging study, is designed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the U.S. and involves 105 healthy volunteers. Preliminary data from this study is expected to be available in the third quarter of 2011.

This Phase I trial is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat 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.

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 2010, 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 success of our ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; 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 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, 2010 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.