GAITHERSBURG, Md., June 22, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that on June 21, 2016, the U.S. Department of Health and Human Services (HHS) issued two solicitation notices with respect to the development and procurement of anthrax vaccines for the Strategic National Stockpile (SNS). The company believes that taken together, these two solicitations represent the government’s intent to establish and maintain a stockpile of anthrax vaccines capable of protecting 25 million people through the continued procurement of 29.4 million doses of BioThrax® (Anthrax Vaccine Adsorbed), the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA), and the advanced development and procurement of up to 27 million dose regimens of a next generation anthrax vaccine. The company believes its next generation anthrax vaccine candidate, NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), with its intended two-dose schedule, satisfies all the requirements set forth in the HHS solicitation. The timing and requirements set forth in the two solicitations issued by HHS fully align with the anticipated licensure of the company’s new large-scale manufacturing facility, Building 55, where both BioThrax and NuThrax are expected to be manufactured. The company intends to respond to both solicitations to meet the government’s timeline of completing the BioThrax procurement contract award in September and timely completion of a next generation anthrax vaccine advanced development contract award.
“Emergent is pleased to be uniquely positioned to respond to both solicitations issued by HHS that represent the U.S. government’s intent to continue to procure BioThrax and to further develop and procure a next generation anthrax vaccine for inclusion into the SNS,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “We believe our vaccine candidate, NuThrax, may be distinctly suited to satisfy all of the requirements of the HHS solicitation for a next generation anthrax vaccine. Taken together, we believe the quantities outlined in the two solicitations express the government’s intention of establishing and maintaining a stockpile of anthrax vaccines capable of protecting 25 million people.”
Notice of Intent to Sole Source BioThrax
HHS issued a Sole Source Notification indicating its intention to award Emergent a contract (Solicitation No. 2016-N-17905) for the purchase of 29.4 million doses of BioThrax by September 23, 2016 with a period of performance of five years. BioThrax, the only anthrax vaccine licensed by the FDA, is indicated for both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease. The solicitation does not state the number of doses to be procured per year.
Notice of Solicitation for Next Generation Anthrax Vaccine
In addition, HHS issued a request for proposal seeking a next generation anthrax vaccine (Solicitation No. 16-100-SOL-00015) for post-exposure prophylaxis of anthrax disease. The vaccine candidate must have the ability to confer protection in one or two doses, a favorable safety profile following completion of clinical studies through Phase 2, demonstrated efficacy in non-clinical studies, and manufacturing consistency necessary to advance towards approval by Emergency Use Authorization. The contract, anticipated to contain a base period of five years is for the development of the vaccine candidate to licensure as well as for the purchase and delivery of an initial two million doses of a next generation anthrax vaccine to the SNS, with potential additional procurement of 12 million doses up to 25 million dose regimens of final drug product. Emergent intends to submit its response with respect to its vaccine candidate NuThrax by the August 5th deadline.
Since the company’s inception in 1998, Emergent has remained a steadfast partner to the U.S. government in support of its long-standing commitment to anthrax preparedness. In a span of almost two decades, through multi-year contracts of increasing size and duration, the U.S. government has procured more than 105 million doses of BioThrax to protect our military and civilian populations from the threat of anthrax as a biological weapon. Over 3.3 million servicemen and women have received the vaccine.
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 our strategy, future operations, prospects, plans, objectives, 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 the ability to obtain a new procurement contract for BioThrax; the ability to obtain a development and procurement contract under the request for proposal for a next generation anthrax vaccine; appropriations for procurement of BioThrax and a next generation anthrax vaccine; and our manufacturing 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.