GAITHERSBURG, Md., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it is launching a ruggedized, military-grade auto-injector device, known as Emergard™, which is designed for intramuscular self-injection of antidotes and other emergency response medical treatments that can address exposure to certain chemical agents and other similar emerging threats. Emergard is not approved by the U.S. Food and Drug Administration (FDA) and is not currently marketed in the U.S., although the company intends to pursue FDA approval of the device. The company has received preliminary interest for Emergard from countries outside the U.S. and anticipates making its first deliveries in limited quantities in Q4 2015.
Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions, stated, “Emergent is excited to add the Emergard auto-injector platform to our portfolio, which allows us to supply critical medical countermeasures to militaries and countries across the globe. Based on internal market research, we estimate the annual worldwide market for military-grade auto-injectors to be between $100-$200 million with one major pharmaceutical company and multiple regional players in the space. We intend to build upon our broad capabilities in government contracting and commercial distribution of medical countermeasures and seize this global market opportunity to drive revenue growth.”
Emergent acquired rights to the device, formerly known as PC-2M, through an exclusive worldwide license agreement with Pharma Consult Ges.m.b.H of Austria, which has been selling the auto-injector in limited quantities to select allied nations. The company has also executed a global manufacturing and supply agreement for Emergard with Nemera Development S.A. Emergent plans to supply cGMP-compliant product through current global sales channels for its other biodefense products.
Emergard is designed to be transported, stored, and operated in a military environment and to ensure needle penetration and successful injection through chemical protective gear.
About Emergent BioSolutions
Emergent BioSolutions is a global specialty biopharmaceutical company dedicated to one simple mission—to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. We also develop and commercialize therapeutics and other specialty products for hospitals and clinics in the areas of hematology/oncology, transplantation, infectious diseases and autoimmune disorders. 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 @emergentbiosolu.
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 the potential uses, market opportunities and intention to seek FDA approval for the auto-injector and any other 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. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, 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 our ability to successfully integrate the business and realize the benefits of the transaction; our ability to obtain sales contracts for the device and to perform under such contracts; the availability of funding for any contracts; the rate and degree of market acceptance of the device; our reliance on a third party to manufacture and supply the device to meet demand under our contracts; the ability of our third party supplier to maintain compliance with cGMP and other regulatory obligations; the success of our efforts to pursue FDA approval of the device; and the success of our commercialization and marketing capabilities and strategy. 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.
CONTACT: Investor Contact: Robert G. Burrows Vice President, Investor Relations 240-631-3280 BurrowsR@ebsi.com Media Contact: Tracey Schmitt Vice President, Global Public Affairs and Corporate Responsibility 240-631-3394 SchmittT@ebsi.com
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