Announced details
Invasive aspergillosis, invasive Scedosporium infection, invasive Lomentospora infection, coccidioidomycosis, invasive infections caused by Scopulariopsis species, and invasive fusariosis
All-cause mortality at Day 42: 23.8% for olorofim and 24.3% for the AmBisome treatment group. Incidence of drug-related adverse events: 35.8% versus 63.9%
Co-developing olorofim. Shionogi & Co., Ltd. holds development and exclusive commercialization rights in Europe and Asia.
Headquartered in Manchester, UK. A biotechnology company based in the UK, the US and Austria. CEO: Francesco Maria Lavino. Focused on discovering and developing new treatments for life-threatening invasive fungal infections.
FDA Orphan Drug Designation, Qualified Infectious Disease Product (QIDP) designation, and EMA orphan designation
U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)
Clinical trial registration number: NCT05101187. The registration numbers and expiration dates for each designation are Not disclosed
F2G: UK, US and Austria. Shionogi & Co., Ltd. headquarters: Kita-ku, Osaka
The impact on consolidated results for the fiscal year ending March 2027 will be immaterial.
The company does not address Contract Value / Offering price.
Oliver et al. (2016), PNAS
Vanbiervliet et al. (2024), BMC Infectious Diseases
Centers for Disease Control and Prevention（CDC）
US Food & Drug Administration（FDA）
| Item | Details |
|---|---|
| Names of Products / Services Covered | Olorofim, AmBisome® |
| Counterparty | F2G Ltd |
| Counterparty overview | Headquartered in Manchester, UK. A biotechnology company based in the UK, the US and Austria. CEO: Francesco Maria Lavino. Focused on discovering and developing new treatments for life-threatening invasive fungal infections. |
| Relationship with the Company | Co-developing olorofim. Shionogi & Co., Ltd. holds development and exclusive commercialization rights in Europe and Asia. |
| Contract Date | 16 May 2022 (license agreement for development and commercialization rights in Europe and Asia) |
| Applicable area | Invasive aspergillosis, invasive Scedosporium infection, invasive Lomentospora infection, coccidioidomycosis, invasive infections caused by Scopulariopsis species, and invasive fusariosis |
| Award/certification name | FDA Orphan Drug Designation, Qualified Infectious Disease Product (QIDP) designation, and EMA orphan designation |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) |
| Registration number and expiry date | Clinical trial registration number: NCT05101187. The registration numbers and expiration dates for each designation are Not disclosed |
| Location | F2G: UK, US and Austria. Shionogi & Co., Ltd. headquarters: Kita-ku, Osaka |
| Quantitative Effects | All-cause mortality at Day 42: 23.8% for olorofim and 24.3% for the AmBisome treatment group. Incidence of drug-related adverse events: 35.8% versus 63.9% |
| Impact on Business Performance | The impact on consolidated results for the fiscal year ending March 2027 will be immaterial. |
| Source | Oliver et al. (2016), PNAS, Vanbiervliet et al. (2024), BMC Infectious Diseases, Centers for Disease Control and Prevention（CDC）, US Food & Drug Administration（FDA） |
Items this document does not state (5)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To provide a new treatment option for patients with invasive aspergillosis who are resistant to, or for whom it is difficult to use, azole antifungal agents.