Announced details
Adenovirus infections following hematopoietic stem cell transplantation, and the treatment of adenovirus infections or diseases associated with adenovirus infections
Exclusive rights secured in all major markets: Japan, the United States and Europe. In Europe, the exclusivity period has been extended by 2 years based on approval under the PIP.
The first patient was enrolled in the Phase III clinical trial in March 2026. Patient enrollment is currently under way in the United States and Europe.
Orphan drug designation; approval based on a Pediatric Investigation Plan (PIP)
Europe: Patent No. 4,506,008, expiring on 29 April 2044. Japan: Patent No. 7,417,339, expiring on 7 August 2043. United States: Patent No. 12,544,392, expiring on 6 May 2044. In Europe, the exclusivity period has been extended by 2 years based on approval under the PIP.
There will be no impact on consolidated results for the fiscal year ending December 2026.
The company does not address Contract Value / Offering price.
The Company’s press release dated 17 March 2026
| Item | Details |
|---|---|
| Names of Products / Services Covered | IV BCV (injectable brincidofovir) |
| Applicable area | Adenovirus infections following hematopoietic stem cell transplantation, and the treatment of adenovirus infections or diseases associated with adenovirus infections |
| Award/certification name | Orphan drug designation; approval based on a Pediatric Investigation Plan (PIP) |
| Registration number and expiry date | Europe: Patent No. 4,506,008, expiring on 29 April 2044. Japan: Patent No. 7,417,339, expiring on 7 August 2043. United States: Patent No. 12,544,392, expiring on 6 May 2044. In Europe, the exclusivity period has been extended by 2 years based on approval under the PIP. |
| Quantitative Effects | Exclusive rights secured in all major markets: Japan, the United States and Europe. In Europe, the exclusivity period has been extended by 2 years based on approval under the PIP. |
| Usage history | The first patient was enrolled in the Phase III clinical trial in March 2026. Patient enrollment is currently under way in the United States and Europe. |
| Impact on Business Performance | There will be no impact on consolidated results for the fiscal year ending December 2026. |
| Source | The Company’s press release dated 17 March 2026 |
Items this document does not state (10)
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 secure intellectual property rights in Europe and strengthen brincidofovir’s intellectual property portfolio ahead of future global expansion.