Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, October 02, 2023
The PDUFA goal date indicates the date for the FDA to complete its review of the NDA, which is supported by clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB),1 TARGET (ABSSSI),2 and a phase 3 study in CABP.3 The ERADICATE study was the largest double-blind randomized registrational study conducted for a new antibiotic treatment in SAB. Dr. Marc Engelhardt, Chief Medical Officer, said: “We are pleased with the FDA's acceptance of our New Drug Application, which is another important step towards bringing ceftobiprole to patients with severe bacterial infections in the US, as there is a high medical need for new antibiotic treatment options, especially in complicated SAB. We look forward to working closely with the FDA throughout their review process.” Ceftobiprole has been designated a Qualified Infectious Disease Product (QIDP) under the US Generate Antibiotics Incentives Now (GAIN) Act; hence, subject to approval, ceftobiprole would be eligible to receive ten years of market exclusivity in the US from the date of approval. Basilea is planning to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the PDUFA goal date. Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work. Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact:
Head of Corporate Communications & Investor Relations
SwitzerlandPhone+41 61 606 1102E-mailmedia_relations@basilea.com
investor_relations@basilea.com
This ad hoc announcement can be downloaded from www.basilea.com.
ERADICATE: ClinicalTrials.gov identifier NCT03138733
TARGET: ClinicalTrials.gov identifier NCT03137173
CABP study: ClinicalTrials.gov identifier NCT00326287
Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed October 01, 2023]