Basilea provides portfolio status update
05 January 2024 - 5:15PM
Basilea provides portfolio status update
- Clinical portfolio
substantially strengthened through business development in 2023;
two phase 3 studies expected to start in 2024
- Cresemba in-market sales of
USD 445 million, increased 22% year-on-year, in 12-month period
ending September 2023; 6-months market exclusivity extension
granted in the US
- FDA PDUFA target action
date on ceftobiprole US NDA April 3; US commercialization
partner expected to be announced prior to FDA
decision
Allschwil, Switzerland, January 5, 2024
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a
commercial-stage biopharmaceutical company committed to meeting the
needs of patients with severe bacterial and fungal infections,
reported today on the progress within its R&D portfolio in 2023
and upcoming milestones and timelines.
David Veitch, Chief Executive Officer, said: “We have achieved
significant milestones in 2023 and remain committed to executing
our strategy to drive long-term value creation. With the addition
of three new assets to our clinical development pipeline, led by
the very promising antifungal fosmanogepix, we are delivering on
our goal of creating a balanced portfolio of innovative drug
candidates for the treatment of severe bacterial and fungal
infections. Furthermore, we have established ourselves as the
partner of choice for companies seeking support in the development
of their assets, with a focus on differentiation and commercial
positioning. The continued commercial success of Cresemba and,
pending US approval, the increasing revenue contributions from
Zevtera, provide us with the financial strength to both advance our
new programs and continue to expand our exciting R&D portfolio,
supporting us in achieving our strategic goal of becoming a leading
anti-infectives company.”
Maintaining its strong momentum, the commercial performance of
Cresemba triggered a number of milestone payments to Basilea. By
year-end 2023, Cresemba was marketed in more than 70 countries,
including the United States (US), most EU member states, China and
Japan. According to the latest available market data, total global
in-market sales of Cresemba in the twelve-month period between
October 2022 and September 2023 amounted to
USD 445 million, a 22 percent growth year-on-year.1
Portfolio key highlights 2023
Cresemba® (isavuconazole) commercial lifespan extension
- In December, the US Food and Drug
Administration (FDA) approved the expanded use of Cresemba in
children with invasive aspergillosis and invasive mucormycosis.2
The FDA also granted pediatric exclusivity, which extends the
period of market exclusivity for Cresemba in the United States by
an additional six months to September 2027.
- In August, Basilea submitted a
similar application for a pediatric label extension of Cresemba in
the European Union and anticipates a decision by the European
Commission around mid-2024. If the pediatric extension is granted,
Cresemba would be eligible to an additional two years of market
exclusivity in the European Union, until October 2027.
Zevtera® (ceftobiprole) US NDA under review
- In September, data from the
successful phase 3 study, ERADICATE, which evaluated ceftobiprole
for the treatment of bacterial bloodstream infections (bacteremia)
caused by Staphylococcus aureus in adult patients, were published
in the New England Journal of Medicine, supporting its potent
activity in treating serious bacterial infections.3
- In August, Basilea submitted a New
Drug Application (NDA) to the FDA, seeking approval of ceftobiprole
for the treatment of 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).4 The
FDA accepted the submission in October and set April 3, 2024, as
the Prescription Drug User Fee Act (PDUFA) target action date, i.e.
the regulatory decision date.
Basilea expects to enter into a commercialization partnership
agreement for ceftobiprole in the US prior to the FDA decision.
Pipeline broadened with promising new clinical drug
candidates
- In November, Basilea acquired the
rights to the phase-3-ready, first-in-class, broad-spectrum
antifungal fosmanogepix, one of the most attractive agents
currently in clinical development, with activity against both
yeasts, including Candida auris, classified as acritical priority
pathogen by the World Health Organization (WHO), and molds that are
resistant to other antifungal agents.
- Acquisition of another potential
first-in-class antifungal, now named BAL2062, with activity against
Aspergillus molds, including azole-resistant strains and other
fungi
- Acquisition of evaluation license
for the novel antibiotic, tonabacase, for the treatment of
infections caused by Staphylococcus aureus, including multi-drug
resistant strains and those forming difficult-to-eradicate
biofilms.
For fosmanogepix, Basilea anticipates to start a phase 3 study
in invasive yeast infections mid-2024 and a phase 3 study in
invasive mold infections, by year-end 2024. For BAL2062 and
tonabacase, the focus for 2024 will be on preclinical profiling in
order to define the optimal positioning and clinical development
plans for these assets. Following a re-prioritization of its
earlier stage research pipeline and re-allocation of resources,
Basilea decided at year-end 2023 to discontinue the preclinical
program on inhibitors of DXR, an enzyme in the bacterial isoprenoid
biosynthesis pathway.5
Throughout 2024, we aim to continue expanding our R&D
portfolio, through the identification of innovative, commercially
attractive assets, addressing unmet medical needs in the treatment
of severe fungal and bacterial diseases.
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 and 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 and clinical 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, Allschwil Hegenheimermattweg 167b4123
AllschwilSwitzerland |
Phone |
+41 61 606 1102 |
E-mail |
media_relations@basilea.cominvestor_relations@basilea.com |
This press release can be downloaded from www.basilea.com.
References
- IQVIA Analytics Link, September 2023. In-market sales reported
as moving annual total (MAT) in US dollar.
- Cresemba US prescribing information:
https://www.astellas.us/docs/cresemba.pdf [Accessed: January 4,
2024]
- ERADICATE (SAB): ClinicalTrials.gov identifier
NCT03138733T. L. Holland, S. E. Cosgrove,
S. B. Doernberg et al. Ceftobiprole for treatment of
complicated Staphylococcus aureus bacteremia. New England Journal
of Medicine 2023 (389), 1390-1401; DOI: 10.1056/NEJMoa2300220
- 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 phase 3 studies in SAB and acute
bacterial skin and skin structure infections (ABSSSI), regulatory
activities and non-clinical work.
- Research reported in this press release is supported by CARB-X.
CARB-X’s funding for the preclinical program on DXR inhibitors is
provided in part with federal funds from the US Department of
Health and Human Services; Administration for Strategic
Preparedness and Response; Biomedical Advanced Research and
Development Authority; under agreement number: 75A50122C00028, and
by awards from Wellcome (WT224842), Germany’s Federal Ministry of
Education and Research (BMBF), the UK Global Antimicrobial
Resistance Innovation Fund (GAMRIF) funded by the UK Government
Department of Health and Social Care (DHSC), and the Bill &
Melinda Gates Foundation. The content of this press release is
solely the responsibility of the authors and does not necessarily
represent the official views of CARB-X or any of its funders.
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