European Commission Approves Pfizer’s EMBLAVEO for Patients with Multidrug-Resistant Infections and Limited Treatment Options - Seite 3

EMBLAVEO was jointly developed with AbbVie. Pfizer holds the global rights to commercialize this therapy outside of the U.S. and Canada, where the rights are held by AbbVie. Development of EMBLAVEO was also supported by public-private partnerships between Pfizer and the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201500029C; and through the EU’s Innovative Medicines Initiative (IMI) – a partnership between the EU and the European pharmaceutical industry – under a project called COMBACTE-CARE (Combatting Bacterial Resistance in Europe – Carbapenem Resistance). The COMBACTE-CARE consortium is a unique public-private collaboration that unites the knowledge and capabilities of leading drug-resistant bacterial infection experts and is supported by the COMBACTE pan-European clinical and laboratory networks.

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Category: Prescription Medicines

Disclosure Notice

The information contained in this statement is as of April 22, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about EMBLAVEO (aztreonam-avibactam), including its potential benefits, a marketing authorization granted by the European Commission, and planned regulatory submissions in other countries, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of EMBLAVEO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed in any other jurisdictions for EMBLAVEO; whether and when regulatory authorities in any such other jurisdictions where applications may be filed or pending may approve such applications, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy, and whether EMBLAVEO will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of EMBLAVEO; the impact of COVID-19 on our business, operations and financial results; and competitive developments.