View printer-friendly version

Download PDF

Emergent BioSolutions Notified by HHS That Its Proposal to Provide 25 Million Doses of Its Recombinant Anthrax Vaccine Is Technically Acceptable and Within the Competitive Range

ROCKVILLE, Md.–(BUSINESS WIRE)–Sept. 12, 2008–Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Department of Health and Human Services (HHS) has informed the company that its proposal to provide a recombinant protective antigen anthrax vaccine (rPA) is technically acceptable and within the competitive range. Emergent’s proposal was in response to HHS’s request for proposal (RFP) for development and delivery of 25 million doses of an rPA anthrax vaccine for the Strategic National Stockpile. As a next step, Emergent will begin to provide additional technical and business information in connection with the ongoing negotiation process.

Companies notified that they are within the competitive range are those that have submitted proposals that have a reasonable chance of being selected for an award based on the factors specified in HHS’s RFP. HHS has indicated that any awards under the rPA RFP would be granted at the end of 2008, at the earliest.

“We are pleased that Emergent’s rPA vaccine candidate has advanced to this next stage and is being considered by HHS to address the government’s goal of procuring 25 million doses of a recombinant anthrax vaccine for the Strategic National Stockpile,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We believe our rPA anthrax vaccine candidate can be successfully developed and, together with BioThrax, our FDA licensed vaccine for the prevention of anthrax, can become an important component of our nation’s stockpile of medical countermeasures.”

The company expects to manufacture its rPA anthrax vaccine, as well as BioThrax, in its recently constructed, large-scale manufacturing facility at its Lansing, Michigan campus. The continued development of this rPA vaccine candidate further solidifies Emergent’s franchise of anthrax countermeasures, which now includes:

ANTHRAX VACCINES

• BioThrax(R) – the only FDA-approved vaccine to prevent the infection of anthrax. Over two million men and women of the United States military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS;
• rPA – a recombinant anthrax vaccine candidate, which is composed of a purified protein with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins; and
• AV7909 – an anthrax vaccine candidate composed of BioThrax(R) and the immunostimulatory oligodeoxynucleotide compound CPG 7909 (VaxImmune(R)) developed by Coley Pharmaceutical Group (purchased by Pfizer Inc. in 2007).

ANTHRAX THERAPEUTICS

• AVP-21D9 – a human monoclonal antibody product candidate being developed as an intravenous post-exposure treatment for patients who present symptoms of anthrax disease; and
• AIG – a polyclonal anthrax immunoglobulin product candidate being developed as an intravenous post-exposure treatment for patients presenting symptoms of anthrax disease, is derived from human plasma from individuals who have been vaccinated with BioThrax.

About Emergent’s Anthrax rPA vaccine candidate

The vaccine candidate, rPA, is based on a recombinant form of the protective antigen protein. This vaccine contains a purified protein (rPA) formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins. The vaccine candidate does not cause anthrax infection and is based on the pioneering work of USAMRIID. Emergent’s rPA has been the subject of two research and development grants totaling approximately $100 million from the National Institute for Allergy and Infectious Diseases (NIAID).

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a leading biopharmaceutical company dedicated to one simple mission–to protect life. Emergent develops, manufactures and commercializes immune-related biologics, vaccines and biotherapeutics that assist the body’s immune system to prevent or treat infectious and other life threatening diseases. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s clinical pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B and chlamydia. 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 our expected revenue growth and net earnings for 2008, 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 timing of, and the potential for successful outcomes resulting from future product development efforts and our ability to obtain additional funding from the U.S. government for them, and other factors identified in the company’s current report on Form 10-Q for the quarter ended June 30, 2008 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.