Infection,
Kidney,
FDA,
Administration,
Staphylococcus,
ASPR,
HHS,
SAB,
Safety,
Ceftobiprole,
Methicillin-resistant Staphylococcus aureus,
Food,
Ceftriaxone,
ESCMID,
Daptomycin,
Partnership,
Fungal infection,
Development,
CABP,
TARGET,
ABSSSI,
Patient,
Staphylococcus aureus,
Dialysis,
Bronchopneumonia,
MRSA,
Vaccine Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.
Key Points:
- Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.
- In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group.
- An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP).
- Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid.
Retrieved on:
Wednesday, April 24, 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 that shareholders approved all proposals of the board of directors at today’s annual general meeting (AGM) for the financial year 2023.
Key Points:
- 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 that shareholders approved all proposals of the board of directors at today’s annual general meeting (AGM) for the financial year 2023.
- At the AGM, the shareholders approved the annual report, the financial statements and the consolidated financial statements for the financial year 2023.
- They also endorsed carrying forward the accumulated deficit and approved the discharge of the members of the board of directors and the management committee.
- Mr. Domenico Scala was re-elected as chairman and Mr. Leonard Kruimer, Dr. Martin Nicklasson, Dr. Nicole Onetto, Dr. Carole Sable and Dr. Thomas Werner were re-elected as members of the board of directors.
Colistin,
Beta-lactam,
Education,
Development,
Partnership,
Patient,
HHS,
Gram-negative bacteria,
Escherichia coli,
World Health Organization,
Infection,
USD,
Administration,
Antibiotic,
BMBF,
Pharmaceutical industry The grant award is to support initial preclinical activities on the antibiotics program recently acquired from Spexis.
Key Points:
- The grant award is to support initial preclinical activities on the antibiotics program recently acquired from Spexis.
- Basilea could receive additional funding from CARB-X, to continue preclinical and early clinical development of the antibiotics program, if the project achieves certain milestones.
- The program comprises antibiotics targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria.
- The molecules belong to one of the very few novel classes of antibiotics in development.
Disease,
MSSA,
MRSA,
Development,
TARGET,
Associate,
Partnership,
CABP,
New Drug Application,
Patient,
HHS,
Mortality,
NDA,
Fungal infection,
Staphylococcus aureus,
Bronchopneumonia,
Infection,
Safety,
SAB,
ASPR,
Staphylococcus,
Ceftobiprole,
Administration,
FDA,
ABSSSI,
Pharmaceutical industry David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
Key Points:
- David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
- The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
- This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
- Through this partnership, 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 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 the continued strong sales performance of the antifungal Cresemba® (isavuconazole) by its license partner Pfizer Inc. in the Asia Pacific region and China exceeded the sales threshold triggering a USD 1.25 million milestone payment.
Key Points:
- 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 the continued strong sales performance of the antifungal Cresemba® (isavuconazole) by its license partner Pfizer Inc. in the Asia Pacific region and China exceeded the sales threshold triggering a USD 1.25 million milestone payment.
- David Veitch, Basilea’s Chief Executive Officer, stated: “This further milestone payment for Asia Pacific and China reflects the significant medical need and strong growth momentum of Cresemba in this region.
- Cresemba is approved and marketed in more than 70 countries, including the United States, most EU member states and additional countries inside and outside of Europe.
- According to the latest available market data, total global in-market sales of Cresemba in the twelve months between October 2022 and September 2023 amounted to USD 445 million, a 22 percent growth year-on-year.1
Retrieved on:
Tuesday, February 13, 2024
Acquisition,
Isavuconazonium,
Investment,
FDA,
Growth,
Ceftobiprole,
PDUFA,
CHF,
Patient,
Acceleration,
FY,
Research,
Partnership Key Points:
- 53 LR
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 its results for the financial year ended December 31, 2023.
- Our strong financial prospects are reflected in our guidance for 2024, which assumes continued significant top line and bottom line growth.
- Basilea recorded an operating profit of CHF 19.2 million (FY 2022: CHF 18.5 million), which is 28% above guidance.
- In 2023, a positive net cash flow of CHF 14.2 million was provided by operating activities, twice as much as in the previous year (FY 2022: CHF 7.1 million).
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 the sales of the antifungal Cresemba® (isavuconazole) in 2023 by its partner Knight Therapeutics Inc. (“Knight”, TSX: GUD) in Latin America exceeded the threshold triggering the first sales milestone payment for this region.
Key Points:
- 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 the sales of the antifungal Cresemba® (isavuconazole) in 2023 by its partner Knight Therapeutics Inc. (“Knight”, TSX: GUD) in Latin America exceeded the threshold triggering the first sales milestone payment for this region.
- David Veitch, Chief Executive Officer, said: “We are very pleased with the commercial progress that Knight has made with Cresemba, which has now triggered the first sales milestone payment from Knight for Latin America.
- The continued growth confirms that Cresemba is serving a high medical need around the world.”
By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States, most EU member states, China, Japan and countries in Latin America.
- 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
Escherichia coli,
World Health Organization,
Patient,
Gram-negative bacteria,
Colistin,
Partnership,
Beta-lactam,
Infection,
Transmembrane protein,
Bacteria,
Klebsiella,
Intellectual property,
CHF,
Lipopolysaccharide,
Klebsiella pneumoniae,
Vaccine We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.”
Key Points:
- We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.”
The antibiotics were developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program and selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria.
- This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria.
- The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator).2 This underscores the potential of this novel class of antibiotics.
- In addition, Basilea assumes the rights and obligations of Spexis, including potential low single-digit percentage royalties on sales, under licensing agreements.
European Commission,
Partnership,
Yeast,
ABSSSI,
Fungus,
FDA,
Antifungal,
PDUFA,
DXR,
WHO,
European,
Staphylococcus aureus,
Genetically modified bacteria,
NDA,
Bronchopneumonia,
SAB,
Civil service commission,
USD,
Infection,
Candida auris,
Fungal infection,
World Health Organization,
Biofilm,
Patient,
Staphylococcus,
CABP,
Pharmaceutical industry By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan.
Key Points:
- By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan.
- 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.
- Basilea expects to enter into a commercialization partnership agreement for ceftobiprole in the US prior to the FDA decision.
- 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.
Retrieved on:
Wednesday, December 20, 2023
Key Points:
- 53 LR
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 will accelerate the repayment of its senior secured loan.
- The senior secured loan from Athyrium Capital Management, LP (“Athyrium”) had an initial total amount of CHF 75 million and a two-year term from September 2022 to September 2024.
- Basilea now plans to have the loan fully repaid by the end of Q1 2024.
- The accelerated repayment reduces our interest payments and fees by approximately CHF 1.5 million, freeing up funds for investing into the continued expansion and progression of our pipeline of promising anti-infective drug candidates and creating long-term value for our shareholders.”
