European Commission Decision Anticipated in November 2020
PARSIPPANY, New Jersey, Oct. 8, 2020 /PRNewswire/ -- Elusys Therapeutics, Inc. [https://c212.net/c/link/?t=0&l=en&o=2944311-1&h=3966555463&u=http%3A%2F%2Fwww.elusys.com%2F&a=Elusys+Therapeutics%2C+Inc.] (Elusys) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization under exceptional circumstances for Obiltoxaximab SFL (obiltoxaximab), the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax. Obiltoxaximab SFL 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.
The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU). A final decision on the marketing authorization application for Obiltoxaximab SFL is anticipated in November 2020. SFL Pharmaceuticals Deutschland GmbH filed the marketing authorization application (MAA) and will act as future marketing authorization holder (MAH) in the EU on behalf of Elusys Therapeutics Inc, the originator of the product.
"This positive CHMP opinion reflects important progress toward our goal of making this important medical countermeasure available in the EU," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "With Anthim already approved and commercially available in the United States and with the recent approval of our New Drug Submission (NDS) by Health Canada, we are looking forward to pursuing additional opportunities to commercialize the product and protect public health in nations where the U.S. has bilateral relations."
The CHMP opinion is based on data from previous 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).
"Our thanks to our EU partner, SFL Pharmaceuticals, for their expert guidance and efforts throughout the EU filing and approval process," added Dr. Posillico.
About obiltoxaximab Obiltoxaximab is approved under the brand name Anthim in the U.S. and Canada. Anthim (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 [https://c212.net/c/link/?t=0&l=en&o=2944311-1&h=1616499786&u=http%3A%2F%2Fwww.elusysproducts.com%2F&a=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.
About Elusys Therapeutics, Inc. 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 August 2020, Health Canada approved Anthim's New Drug Submission (NDS) for the treatment of inhalation anthrax. See www.elusysproducts.com [https://c212.net/c/link/?t=0&l=en&o=2944311-1&h=1616499786&u=http%3A%2F%2Fwww.elusysproducts.com%2F&a=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 [https://c212.net/c/link/?t=0&l=en&o=2944311-1&h=3248101214&u=http%3A%2F%2Fwww.elusys.com%2F&a=www.elusys.com].
SAFE HARBOR STATEMENT 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.
CONTACT: Jeremy Middleton, Elusys Therapeutics, Inc., t: 973-787-8514, e: firstname.lastname@example.org
Web site: http://www.elusys.com/