Isavuconazonium

Basilea reports strong 2023 full-year results with profitability significantly above guidance, whilst substantially expanding the R&D portfolio

Retrieved on: 
Tuesday, February 13, 2024
Acquisition, Isavuconazonium, Investment, FDA, Growth, Ceftobiprole, PDUFA, CHF, Patient, Acceleration, FY, Research, Partnership

53 LR

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).

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.

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 strong revenue and profit growth in first half-year 2023

Retrieved on: 
Tuesday, August 15, 2023
US Foods, New Drug Application, LR, NDA, Research, Ceftobiprole, Acquisition, Patient, Growth, CHF, Food, Pharmaceutical industry, Cryptocurrency, Allschwil, Isavuconazonium

David Veitch, Chief Executive Officer, stated: “We made very good progress on the implementation of our growth strategy, which is reflected in our strong financial performance, with a 57 percent growth year-on-year in Cresemba and Zevtera related revenue.

Key Points: 
  • David Veitch, Chief Executive Officer, stated: “We made very good progress on the implementation of our growth strategy, which is reflected in our strong financial performance, with a 57 percent growth year-on-year in Cresemba and Zevtera related revenue.
  • We are also in discussions with regard to the in-licensing or acquisition of a number of novel, differentiated anti-infective assets, to complement our pipeline and support long-term growth.
  • In H1 2023, research and development expenses decreased by 42% to CHF 21.5 million (H1 2022: CHF 37.1 million).
  • In H1 2023, an operating profit of CHF 36.9 million was recorded (H1 2022: operating loss of CHF 10.0 million) as well as a net profit of CHF 31.8 million (H1 2022: net loss of CHF12.2 million).

U.S. FDA Accepts Astellas' sNDA for CRESEMBA® (isavuconazonium sulfate) in Children

Retrieved on: 
Thursday, August 10, 2023
Prescription Drug User Fee Act, Head, New Drug Application, Pharmacokinetics, Research, Doctor of Philosophy, Shanda, MD, Patient, Azole, Physician, Blood, Cancer, Disease, PDUFA, Ageing, Trial of the century, Immunodeficiency, Fungal infection, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Isavuconazonium, Food, Safety, Pharmaceutical industry, Astellas Pharma

NORTHBROOK, Ill., Aug. 10, 2023 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for CRESEMBA® (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal drug, seeking approval for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged one to 17 years old. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.
  • CRESEMBA is already approved by the FDA for the treatment of IA and IM in adults.
  • If approved for pediatric use, it may offer children significant advances in treatment or may provide a treatment where no adequate therapy exists.
  • "This sNDA acceptance by the FDA brings Astellas one step closer to helping pediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved."

Continued strong Cresemba® (isavuconazole) sales by Pfizer trigger USD 26 million sales milestone payments to Basilea

Retrieved on: 
Thursday, June 8, 2023
Isavuconazonium, LR, Patient, Pharmaceutical industry, Allschwil, EU, Pfizer

53 LR

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 or fungal infections, reported today that sales of the antifungal Cresemba® (isavuconazole) by its license partner Pfizer in Europe and the Asia Pacific and China regions, respectively, exceeded thresholds that triggered two separate milestone payments totaling USD 26.25 million to Basilea.
  • Under the terms of the agreement, Basilea remains eligible for milestone payments of up to approximately CHF 515 million, in addition to receiving mid-teen royalties on net sales.
  • Cresemba has been approved in 73 countries to date and is currently marketed in 67 countries, including the United States, most EU member states and additional countries inside and outside of Europe.
  • In 2022, total global in-market sales of Cresemba amounted to USD 373 million, a 15 percent growth year-on-year.1

Global Invasive Fungal Infections Market Report 2023: Increasing Invasive Fungal Infections with Life-threatening Conditions Drive Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, May 29, 2023
Biotechnology, Pharmaceutical, Health, Molecule, Amphotericin B, Fungal infection, Risk factor, Imidazole, Prevalence, Diabetes, HIV, Blastomycosis, Posaconazole, Infection, Candidiasis, Overalls, Isavuconazonium, Ageing, Mucormycosis, Merck & Co., Polyene, Fungemia, CDC, Incidence, AR, Patient, Developed country, ROW, Growth, Mortality, Merck, Immunodeficiency, Immunosuppression, Cryptococcus, Pfizer, Triazole, Pharmaceutical industry, Vaccine, Voriconazole, Echinocandin, Aspergillosis, Azole, Fluconazole

However, there are also antibody molecules in early preclinical development, which are currently not on the market.

Key Points: 
  • However, there are also antibody molecules in early preclinical development, which are currently not on the market.
  • The increasing use of broad-spectrum antibiotics, the aging population, and the growing prevalence of immunocompromised patients are driving the growth of invasive candidiasis.
  • By Region: The report provides insight into the invasive fungal infections market based on the geographical operations, namely North America, Europe, Asia Pacific, and ROW.
  • The North American region has emerged as a dominant player in the invasive fungal infections market, owing to several key factors.

Basilea announces CHF 5 million milestone payment from Asahi Kasei Pharma for antifungal Cresemba® (isavuconazole) in Japan

Retrieved on: 
Thursday, March 23, 2023
AKP, Patient, Fungal infection, Pharmaceutical industry, EU, Isavuconazonium

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that its license partner Asahi Kasei Pharma (“AKP”) has reported the achievement of a milestone related to the launch of Cresemba® (isavuconazole) in Japan, which triggered a CHF 5 million payment from AKP to Basilea.

Key Points: 
  • Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that its license partner Asahi Kasei Pharma (“AKP”) has reported the achievement of a milestone related to the launch of Cresemba® (isavuconazole) in Japan, which triggered a CHF 5 million payment from AKP to Basilea.
  • David Veitch, Basilea’s CEO, stated: “We congratulate our partner AKP on this significant milestone, following the marketing authorization in Japan in December 2022.
  • Japan is an important commercial market for newer antifungals and we look forward to continue working together with AKP to make Cresemba available to patients in Japan for whom invasive fungal infections can pose a serious threat.”
    Cresemba is approved in 73 countries to date and is currently marketed in around 65 countries, including the United States, China, Japan, 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 2021 and September 2022 amounted to USD 363 million, a 19 percent growth year-on-year.1

Basilea reports strong financial results 2022 based on successful implementation of new strategy

Retrieved on: 
Tuesday, February 14, 2023
Fungal infection, LR, Investment, Bronchopneumonia, Patient, BARDA, Research, CHF, ISIN, Ceftobiprole, Staphylococcus aureus, Staphylococcus, FGFR, Partnership, Growth, Pharmaceutical industry, Cryptocurrency, Isavuconazonium

53 LR

Key Points: 
  • 53 LR
    Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today its results for the financial year ended December 31, 2022.
  • Our commercial-stage anti-infectives brands made great progress in 2022 and are well positioned to continue their success story in 2023 and beyond.
  • In addition, we have significantly reduced our debt level in 2022, whilst avoiding dilution for our shareholders.
  • Our strong financial prospects are reflected in our 2023 financial guidance.