GAITHERSBURG, Md, USA--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) today announced the successful completion of the Mutual Recognition Procedure (MRP) for market authorisation of BioThrax® (Anthrax Vaccine Adsorbed) in five Concerned Member States (CMS) within the European Union (EU), including Italy, the Netherlands, Poland, the U.K., and France (where it will be marketed as BaciThrax™). Emergent filed the mutual recognition application based on the existing Marketing Authorisation of BioThrax in Germany granted by the Paul-Ehrlich-Institut. Following the positive MRP outcome, national licences are due to be issued shortly by the five CMS countries.
“Expanding the licence of BioThrax globally has been part of Emergent’s strategy and we are pleased with the completion of this process and the positive outcome of our application for market authorisation in these Member States,” said Adam Havey, Executive Vice-President, Business Operations at Emergent BioSolutions. “With the heightened awareness of the need to protect militaries and civilians against public health threats, we are proud to be able to support allied governments with preparedness solutions that align with their national security plans. Based on this regulatory approval, we look forward to further expanding our footprint within the EU.”
Where approved in Europe, BioThrax is indicated for prevention of disease caused by Bacillus anthracis in adults at risk of exposure. BioThrax is administered in a three-dose primary schedule (0, 1 and 6 months) with boosters at three-year intervals recommended thereafter. For full details of EU prescribing information, please visit https://emergentbiosolutions.com/sites/default/files/inline-files/SmPC_EN%20v.11.5%2003Apr2018_1.pdf.
BioThrax is also licensed by the U.S. Food and Drug Administration for the active immunisation for prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age for both pre-exposure and post-exposure prophylactic use. For full U.S. prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.
BioThrax is also licensed by the Singapore Health Sciences Authority.
BioThrax is the only anthrax vaccine licensed by the U.S. Food and Drug Administration, the Singapore Health Sciences Authority, and Germany’s Paul-Ehrlich-Institut, for the prevention of anthrax disease. The safety and efficacy of BioThrax have not been established in paediatric or geriatric populations. Individuals are not considered protected until they have completed the three-dose primary immunisation series. Vaccination with BioThrax may not protect all individuals.
BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Over 14 million doses of BioThrax have been administered to more than 3 million individuals.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
Safe Harbour 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 containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate and there can be no guarantee that BioThrax will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels in any country where market authorisation has been granted. Investors should realise that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
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 demand and governmental funding for and the success of marketing efforts related to BioThrax in countries where it has been approved; the ability to obtain licensure of BioThrax in other foreign countries, and regulatory actions or government regulations generally. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.