PARSIPPANY, NJ, DECEMBER 2, 2020 – Elusys Therapeutics, Inc. (Elusys) today announced that the European Commission has approved obiltoxaximab, the company’s monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax. Obiltoxaximab is indicated in all age groups in combination with appropriate antibacterial drugs for the treatment of inhalational anthrax due to Bacillus anthracis; and for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. This EU approval for obiltoxaximab will be automatically converted to a UK marketing authorization on January 1, 2021.
SFL Pharmaceuticals Deutschland GmbH (SFL Pharmaceuticals) will act as marketing authorization holder (MAH) in the EU and the UK on behalf of Elusys, the originator of the product.
“The European Commission’s approval of obiltoxaximab will help to protect public health and enhance national health security throughout the EU,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “This latest approval further demonstrates Elusys’ commitment to expanding future procurement opportunities of this critical medical countermeasure in regions where the U.S. has bilateral relations. We look forward to working with our partner, SFL Pharmaceuticals, as they continue to guide our distribution efforts in the EU and the UK.”
The European Commission approval is based on data from studies funded by U.S. government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), and the U.S. Department of Defense (DoD).
Obiltoxaximab is approved under the brand name Anthim® in the U.S. and Canada. In the EU obiltoxaximab will be approved under brand name Obiltoxaximab SFL. Obiltoxaximab recently received approval by Health Canada for use in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs; and for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate. See www.elusysproducts.com for full prescribing information for the U.S. and Canada. Anthim is produced in a single dose liquid formulation for intravenous (IV) infusion.
Elusys Therapeutics, a private company based in Parsippany, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. In early 2016, Anthim®(obiltoxaximab), the company’s monoclonal antibody (mAb) anthrax antitoxin, received market clearance by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of inhalational anthrax in combination with appropriate antibiotics. Elusys was awarded two delivery orders from the U.S. government – $45 million in 2015 and $25 million in 2018 – to produce Anthim for the U.S. Strategic National Stockpile (SNS), the U.S. government’s repository of critical medical supplies for biowarfare preparedness. In July 2020, Health Canada approved Anthim’s New Drug Submission (NDS) for the treatment of inhalation anthrax. See www.elusysproducts.com for full prescribing information for the U.S. and Canada. Elusys has received over $240 million in development grants and contracts from BARDA, the National Institutes of Health (NIH), and the U.S. Department of Defense (DoD). For more information, please visit www.elusys.com.
This announcement includes statements that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. This release includes forward looking statements. 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, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties and other important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements. The guidance in this presentation is only effective as of the date given and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.
Elusys Therapeutics, Inc.
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