Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole
2023年8月4日 - 2:15PM
Basilea announces submission of a New Drug Application to the US
Food and Drug Administration for its antibiotic ceftobiprole
- Seeking approval
for Staphylococcus aureus
bacteremia (SAB), acute
bacterial skin and skin structure infections
(ABSSSI), and community-acquired
bacterial pneumonia (CABP)
- NDA eligible for
Priority
Review
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, August
04, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial and fungal infections,
announced today that it has submitted a New Drug Application (NDA)
to the US Food and Drug Administration (FDA). With this NDA,
Basilea is seeking approval of its antibiotic ceftobiprole for
treating patients in three indications: Staphylococcus aureus
bacteremia (SAB), including right-sided infective endocarditis,
acute bacterial skin and skin structure infections (ABSSSI) and
community-acquired bacterial pneumonia (CABP).
Dr. Marc Engelhardt, Chief Medical Officer, said:
“Staphylococcus aureus bacteremia is a common bloodstream infection
with an estimated 120,000 cases in the US per year and is
associated with substantial morbidity and mortality. Our completed
phase 3 program demonstrates the efficacy of ceftobiprole in this
complicated infection. The additional successfully completed phase
3 studies in ABSSSI and CABP support the broad clinical utility of
ceftobiprole. Based on its potent antibacterial activity
ceftobiprole could become a valuable new treatment option for
severe bacterial infections in the US, especially when
methicillin-resistant Staphylococcus aureus bacteria, MRSA, are of
concern.”1
The NDA submission includes clinical efficacy and safety data
from the phase 3 studies ERADICATE (SAB),2 TARGET (ABSSSI),3 and a
phase 3 study in CABP.4 The ERADICATE study was the largest
double-blind randomized registrational study conducted for a new
antibiotic treatment in SAB.
Ceftobiprole has been designated a Qualified Infectious Disease
Product (QIDP) under the US Generate Antibiotics Incentives Now
(GAIN) Act, which provides for a Priority Review within eight
months from submission. Provided that the NDA submission is
accepted, Basilea expects a decision by the FDA on the NDA in the
second quarter of 2024. Basilea plans to commercialize ceftobiprole
in the US through a partner and intends to enter into such a
partnership prior to the FDA’s decision on the NDA.
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.
About ceftobiprole
Ceftobiprole medocaril, the prodrug of the active moiety
ceftobiprole, is a cephalosporin antibiotic for intravenous
administration, with rapid bactericidal activity against a wide
range of Gram-positive bacteria such as Staphylococcus aureus,
including methicillin-resistant strains (MRSA), and Gram-negative
bacteria.5 The brand is currently approved and marketed as Zevtera®
and Mabelio® in several countries in Europe and beyond for the
treatment of adult patients with hospital-acquired bacterial
pneumonia (HABP), excluding ventilator-associated bacterial
pneumonia (VABP), and for the treatment of community-acquired
bacterial pneumonia (CABP). Basilea has entered into license and
distribution agreements covering more than 80 countries.
Ceftobiprole is currently not approved and partnered in the US.
About Basilea
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.
Disclaimer
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:
Peer Nils Schröder, PhD Head of Corporate
Communications & Investor RelationsBasilea Pharmaceutica
International Ltd, AllschwilHegenheimermattweg 167b4123
AllschwilSwitzerland |
Phone |
+41 61 606 1102 |
E-mail |
media_relations@basilea.com investor_relations@basilea.com |
This ad hoc announcement can be downloaded from
www.basilea.com.
References
- Source for number of SAB cases in the quote:
A. P. Kourtis, K. Hatfield, J. Baggs et al. Vital signs:
Epidemiology and recent trends in methicillin-resistant and in
methicillin-susceptible Staphylococcus aureus bloodstream
infections – United States. MMWR Morbidity and mortality weekly
report 2019 (68), 214-219
- ERADICATE: ClinicalTrials.gov identifier NCT03138733T. L.
Holland, S. E. Cosgrove, S. B. Doernberg et al.
Ceftobiprole compared to daptomycin with or without optional
aztreonam for the treatment of complicated Staphylococcus aureus
(SAB): Results of a phase 3, randomized, double-blind trial
(ERADICATE). Open Forum Infectious Diseases 2022 Dec (9), Suppl. 2
(LB2302)
- TARGET: ClinicalTrials.gov identifier
NCT03137173J. S. Overcash, C. Kim, R. Keech R
et al. Ceftobiprole compared with vancomycin plus aztreonam in the
treatment of acute bacterial skin and skin structure infections:
Results of a phase 3, randomized, double-blind trial (TARGET).
Clinical Infectious Diseases 2021 (73), e1507-e1517
- CABP study: ClinicalTrials.gov identifier NCT00326287S. C.
Nicholson, T. Welte, T. M. File Jr. et al. A randomised,
double-blind trial comparing ceftobiprole medocaril with
ceftriaxone with or without linezolid for the treatment of patients
with community-acquired pneumonia requiring hospitalization.
International Journal of Antimicrobial Agents 2012 (39),
240-246
- Summary of Product Characteristics (SmPC) Zevtera:
https://www.medicines.org.uk/emc/product/9164/smpc [Accessed
August 03, 2023]
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