EBS Emergent Biosolutions Inc

Emergent BioSolutions Inc. (NYSE: EBS) announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, executed a contract modification for the second option period, valued at approximately $16.7 million, for drug product process and analytical testing validation and long-term stability for Ebanga™ (ansuvimab-zykl). Ebanga™ is indicated for the treatment of infection caused by Zaire Ebola virus.

“We are delighted our continued collaboration with BARDA is advancing Ebanga™ development toward supplying treatment and ensuring communities are prepared against Ebola,” said Simon Lowry, M.D., chief medical officer, head of research and development, Emergent. “Ebola is a devastating infectious illness with limited treatment options. This important work reinforces Emergent’s leadership in developing solutions to address priority public health threats.”

The existing 10-year contract consists of a base period of performance with two option periods for advanced development valued at approximately $118 million, and option periods for procurement of Ebanga™ treatment over five years valued at up to $583 million. Under the terms of the contract, Emergent will complete activities to advance the development of Ebanga™ through post-licensure commitments. These activities include manufacturing scale-up, transferring manufacturing technology, and completing stability studies, as well as the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under contract 75A50123C00037.

About Ebanga™

Indication

Ebanga™ (ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.

Limitations of Use:

The efficacy of Ebanga™ has not been established for other species of the Ebolavirus and Marburgvirus genera.

Zaire ebolavirus can change over time, and factors such as emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use Ebanga™.

Important Safety Information

Hypersensitivity Reactions Including Infusion-Associated Events: Hypersensitivity reactions including infusion-associated events have been reported with Ebanga™. These may include acute, life-threatening reactions during and after the infusion. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever, during and following Ebanga™ infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of Ebanga™ immediately and administer appropriate emergency care.

Adverse reactions: The most frequently reported adverse events (≥ 5%) after administration of Ebanga™ were pyrexia (fever), tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills. The adverse event profile in adult and pediatric (birth to less than 18 years of age) subjects treated with Ebanga™ was similar.

U.S. Prescribing Information

The full Prescribing Information for Ebanga™ vaccine can be found here.

About Ebola Virus DiseaseOrthoebolavirus zairense, referred to as Ebola virus disease (EVD) is severe and often fatal with case fatality rates ranging from 25% to 90%, and is transmitted via bodily fluids, zoonotic transmission, or contact with contaminated surfaces. The U.S. Department of Homeland Security has determined that EVD poses a material threat to national health security. To augment the U.S. government’s response capabilities, BARDA is pursuing advanced development, licensure, and procurement of therapeutics that can be deployed in outbreaks.

About Emergent BioSolutionsAt Emergent, our mission is to protect and enhance life. For over 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.

Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the agreement with BARDA for the advanced development, manufacturing scale-up, and procurement of Ebanga™ treatment, including the potential exercise of option periods and any payments in connection therewith, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on Emergent’s current intentions, beliefs, and expectations regarding future events. Emergent cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Emergent’s expectations. Readers 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, Emergent does 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 Emergent’s actual results to differ materially from those indicated by any forward-looking statements.

Readers should consider this cautionary statement, as well as the risk factors identified in Emergent’s periodic reports filed with the U.S. Securities and Exchange Commission when evaluating Emergent’s forward-looking statements.

Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com 

Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com