GAITHERSBURG, Md., July 19, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with GSK (LSE/NYSE: GSK), one of the world’s leading healthcare companies, to acquire raxibacumab, a fully human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment and prophylaxis of inhalational anthrax. Emergent also plans to assume responsibility for a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), valued at up to approximately $130 million, to supply the product to the U.S. Strategic National Stockpile (SNS). The all-cash transaction consists of a $76 million upfront payment and up to $20 million in product sale and manufacturing-related milestone payments, all of which would likely become due in 2019. Emergent expects to purchase product from GSK to fulfill deliveries to the SNS under the current BARDA contract and plans to transfer raxibacumab manufacturing to existing Emergent facilities in Baltimore, Maryland in 2020.
Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions, stated, “Emergent is committed to continuing to build a portfolio of medical countermeasures that meets our customers’ needs to protect citizens from a broad array of public health threats. The addition of this critical countermeasure further strengthens our leadership position in this market and expands our franchise of vaccines and therapeutics addressing Category A bioterrorism threats. We look forward to establishing raxibacumab as an anchor FDA-approved product for our newly-expanded Bayview manufacturing facility in Baltimore, Maryland. As we focus on providing preparedness solutions to public health threats, we will continue to actively pursue additional acquisition opportunities that leverage our core competencies and drive growth.”
Upon the closing of the transaction, Emergent will:
- Acquire raxibacumab, including corresponding product rights, regulatory approvals and intellectual property rights; and
- Plan to assume responsibility for an existing contract with BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, with a delivery order performance period through November 2019 to supply raxibacumab to the SNS, with a remaining value of up to approximately $130 million.
Emergent expects to fulfill the deliveries of raxibacumab to the SNS by the end of 2019 under the current BARDA contract, subject to the availability of funding, and expects to negotiate a follow-on contract with the U.S. government to ensure the uninterrupted supply of this critical medical countermeasure to the SNS. Under the terms of the acquisition agreements, Emergent expects to purchase product from GSK to enable completion of deliveries to the SNS under the existing BARDA procurement contract.
In addition, Emergent intends to transfer all manufacturing related to raxibacumab to existing Emergent facilities in 2020. The company plans to transfer bulk manufacturing to its Bayview facility, also known as its Center for Innovation in Advanced Development and Manufacturing, where it is intended to serve as a commercial anchor product and the fill/finish process to its Camden facility. Both facilities are located in Baltimore, Maryland.
This transaction, which is subject to customary closing conditions including antitrust regulatory clearance, is anticipated to close in 2017. The company expects that this transaction will be accretive upon first product delivery under the current BARDA contract, which is anticipated within three to six months from closing.
Cowen is acting as financial advisor to Emergent in this transaction.
Raxibacumab is the first monoclonal antibody approved by the FDA for the treatment and prophylaxis of inhalational anthrax due to Bacillus anthracis. It was approved in December 2012 and has Orphan Drug designation in the U.S. Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab has been supplied to the SNS since 2009 under contracts with BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
About Emergent BioSolutions
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 emerging 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 emergentbiosolutions.com. Follow us @emergentbiosolu.