Allschwil

Continued strong Cresemba® (isavuconazole) sales performance in Asia Pacific and China triggers third sales milestone payment for the region from Pfizer this year

Retrieved on: 
Monday, November 20, 2023
NYSE, PFE, Patient, Pharmaceutical industry, Isavuconazonium, Pfizer, Allschwil

David Veitch, Basilea’s Chief Executive Officer, stated: “This marks the third sales milestone payment for Asia Pacific and China this year.

Key Points: 
  • David Veitch, Basilea’s Chief Executive Officer, stated: “This marks the third sales milestone payment for Asia Pacific and China this year.
  • It highlights that Cresemba continues to serve a high medical need and also reflects the significant commercial potential of Cresemba in this region.
  • Cresemba is approved in 76 countries to date and is currently marketed in 71 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 July 2022 and June 2023 amounted to USD 421 million, a 19 percent growth year-on-year.1

Basilea announces acquisition of fosmanogepix, a phase-3-ready broad-spectrum antifungal

Retrieved on: 
Monday, November 13, 2023
NDA, Isavuconazonium, Pfizer, Safety, Food, US Foods, Basilea Pharmaceutica, Patient, FDA, Fungal infection, USD, CHF, FY, Candida auris, Pharmaceutical industry, Fungemia, Allschwil

In addition, Basilea has acquired the rights to a preclinical antifungal compound.

Key Points: 
  • In addition, Basilea has acquired the rights to a preclinical antifungal compound.
  • Fosmanogepix is a potential first-in-class antifungal treatment candidate with a novel mechanism of action.
  • Basilea assumes all rights and obligations from previous agreements, comprising potential development, regulatory, and commercial milestone payments of up to USD 396 million, as well as tiered single-digit royalty payments.
  • Correspondingly, the BARDA reimbursements, as well as operating expenses, will be reduced by the amount of such application fee.

Boehringer Ingelheim expands immuno-oncology portfolio with the acquisition of bacterial cancer therapy specialist T3 Pharma

Retrieved on: 
Wednesday, November 22, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Boehringer, Trichloroethylene, Acquisition, Innovation, Ingelheim am Rhein, Potyvirus, Boehringer Ingelheim, Tissue, Cancer, Innovation Unit, Patient, Bi-specific T-cell engager, Bacteria, Immunotherapy, CHF, Pharma, Fine chemical, Vaccine, Allschwil

Boehringer Ingelheim today announced the acquisition of privately-held T3 Pharmaceuticals AG (“T3 Pharma”), a clinical stage Swiss biotech company, for an amount of up to 450 million CHF.

Key Points: 
  • Boehringer Ingelheim today announced the acquisition of privately-held T3 Pharmaceuticals AG (“T3 Pharma”), a clinical stage Swiss biotech company, for an amount of up to 450 million CHF.
  • T3 Pharma has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor micro-environments.
  • “The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline portfolio and is synergistic with many of our existing R&D programs.
  • Boehringer Ingelheim is adopting a comprehensive approach to cancer therapy development including both cancer cell-directed and immuno-oncology approaches.

Spexis Announces Changes to the Executive Committee

Retrieved on: 
Wednesday, November 1, 2023
Knowledge, Railway Executive Committee, Trust, LR, Allschwil, Rare, Executive Committee, Therapy, Human resources, Management, Spexy Beast

Allschwil, Switzerland, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that Hernan Levett, currently Chief Financial Officer, has decided to pursue a new career opportunity outside the company. He will continue to support the company as a strategic advisor on financial transactions and will depart the company effective December 1, 2023. Martin Jakobovic, currently Head of Finance, will succeed Hernan Levett as interim Chief Financial Officer joining the Executive Committee on December 1, 2023. Additionally, Muriel Fleming, currently Head of Human Resources, will assume additional responsibilities related to administration and facilities, as well as joining the Executive Committee of Spexis also on December 1, 2023.

Key Points: 
  • He will continue to support the company as a strategic advisor on financial transactions and will depart the company effective December 1, 2023.
  • Martin Jakobovic, currently Head of Finance, will succeed Hernan Levett as interim Chief Financial Officer joining the Executive Committee on December 1, 2023.
  • Additionally, Muriel Fleming, currently Head of Human Resources, will assume additional responsibilities related to administration and facilities, as well as joining the Executive Committee of Spexis also on December 1, 2023.
  • “I would like to thank Jeff, the board of directors, our shareholders, and the entire Spexis team for their trust, support, and commitment.

Basilea announces exclusive license and option agreement for potential first-in-class clinical-stage antibacterial agent

Retrieved on: 
Tuesday, October 31, 2023
KOSDAQ, Trial of the century, South Korea, MSSA, Bacteriophage, Biofilm, Intron, Gram-positive bacteria, Infection, Virus, Exercise, Biotechnology, A-DNA, Antimalarial medication, MRSA, LR, Bacteria, Korea, Patient, Death, Pharmaceutical industry, Vaccine, Basel, Allschwil

Tonabacase is a potential first-in-class clinical-stage antibacterial of the endolysin class.

Key Points: 
  • Tonabacase is a potential first-in-class clinical-stage antibacterial of the endolysin class.
  • Over the course of 2024, Basilea will investigate various hypotheses in a number of preclinical studies to determine the optimal future clinical development program for tonabacase.
  • Upon successful completion of the preclinical evaluation phase, Basilea will have the exclusive option to license tonabacase for further clinical development and commercialization.
  • This transaction has no impact on Basilea’s financial guidance for 2023, provided on August 15, 2023.

iNtRON, Executes Evaluation License and Option Agreement for SAL200

Retrieved on: 
Tuesday, October 31, 2023
Infection, US, Intron, Basel, Biotechnology, Probability, NDA, Fungal infection, Pharmaceutical industry, Allschwil

BOSTON and SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", www.intodeworld.com ) has announced today that they have signed an "EVALUATION LICENSE AND OPTION AGREEMENT" with Basilea Pharmaceutica Ltd, Allschwil ("Basilea"), granting Basilea the option to enter into an exclusive license agreement for the antibacterial bio-drug SAL200 (Tonabacase).

Key Points: 
  • BOSTON and SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", www.intodeworld.com ) has announced today that they have signed an "EVALUATION LICENSE AND OPTION AGREEMENT" with Basilea Pharmaceutica Ltd, Allschwil ("Basilea"), granting Basilea the option to enter into an exclusive license agreement for the antibacterial bio-drug SAL200 (Tonabacase).
  • iNtRON will receive an initial upfront payment upon the execution of this agreement and will receive an additional payment upon Basilea exercising the option to negotiate an exclusive license agreement after the completion of the evaluation test, which can last up to one year.
  • Certain essential terms of the exclusive license agreement have been pre-agreed upon along with the current agreement.
  • iNtRON has been actively discussing the exclusive license agreement with Basilea, who showed keen interest in SAL200.

Basilea announces acquisition of novel clinical-stage antifungal for treatment of Aspergillus mold infections

Retrieved on: 
Thursday, October 19, 2023
FDA, Isavuconazonium, Gravitas, US Foods, Safety, I.V. (song), QIDP, LR, USD, Therapy, Patient, Infection, Pharmaceutical industry, Aspergillus, Allschwil

David Veitch, Chief Executive Officer of Basilea, stated: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, stated: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera.
  • Based on its novel mechanism of action which results in rapid fungicidal activity in vitro, BAL2062 could become a valuable treatment option against difficult-to-treat invasive mold infections.
  • To define the optimal positioning and the most efficient clinical development path, we will initiate a focused preclinical profiling program.
  • In addition, Basilea will pay tiered royalties on sales starting in the low single-digit percentage range, going to the mid-single-digit percentage range.

Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023

Retrieved on: 
Tuesday, October 17, 2023
Efficacy, Staphylococcus, Methicillin-resistant Staphylococcus aureus, Ambrose, Abstract, Treatment, Clinical, Circulatory system, MRSA, Biomedical Advanced Research and Development Authority, BARDA, Enterococcus faecalis, Infection, ASPR, MSSA, IDSA, Isolates, Laboratory, Liolios Xirolivaditis, Staphylococcus aureus, PK/PD models, SAB, ABSSSI, CABP, Bronchopneumonia, Administration for Strategic Preparedness and Response, Streptococcus pneumoniae, Prescription Drug User Fee Act, Duke University School of Medicine, Infectious Diseases Society of America, Randomness, Development, Administration, Safety, Patient, PDUFA, HHS, Pharmaceutical industry, Vaccine, Ceftobiprole, Litherland, Enterococcus, Allschwil, Streptococcus, Bloodstream infections

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.

Key Points: 
  • Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.
  • It also provides results of pharmacokinetic-pharmacodynamic modeling supporting the dosing regimens to treat severe bacterial infections from the successful clinical phase 3 studies.
  • Abstract #1946 – In Vitro Activity of Ceftobiprole against Staphylococcus aureus Bacteremia Isolates from the United States (2018–2020) – L. Duncan, M. Castanheira, J. I.
  • Smart, M. E. Jones, P. G. Ambrose, K. Litherland
    Abstract #2561 – Population Pharmacokinetic Analyses for Ceftobiprole Using Data from Phase 1 and 3 Studies – A. P. Cammarata, K. Litherland, M. C. Safir, S. M. Bhavnani, M. Saulay, J. I.

Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole

Retrieved on: 
Monday, October 2, 2023
SAB, ASPR, US Foods, Prescription Drug User Fee Act, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, PDUFA, Infection, Fungal infection, FDA, Safety, BARDA, TARGET, Pharmaceutical industry, Allschwil, New Drug Application

Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024

Key Points: 
  • Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024
    Ad hoc announcement pursuant to Art.
  • 53 LR
    Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year.
  • The FDA has set April 03, 2024, as the Prescription Drug User Fee Act (PDUFA) goal date.
  • 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 announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia

Retrieved on: 
Thursday, September 28, 2023
SAB, ASPR, Staphylococcus, The New England Journal of Medicine, US Foods, Biomedical Advanced Research and Development Authority, Microbiology, MSSA, HHS, Clostridioides, Daptomycin, Overalls, Infection, Survival, MRSA, Administration for Strategic Preparedness and Response, Duke University School of Medicine, Associate, Staphylococcus aureus, Ceftobiprole, NEJM, ABSSSI, Clostridioides difficile infection, Administration, Development, Patient, Fungal infection, Disease, Mortality, Bacteria, BARDA, Food, Methicillin-resistant Staphylococcus aureus, New Drug Application, Pharmaceutical industry, Vaccine, Allschwil, Medicine

ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.

Key Points: 
  • ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.
  • Using a pre-defined non-inferiority margin of 15%, treatment with ceftobiprole was non-inferior to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group.
  • The results for the primary study outcome were consistent in key subgroups, including patients with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA).
  • Ceftobiprole was generally well tolerated and showed a safety profile consistent with previous phase 3 studies and the post-marketing experience.