Announced details
Management and relief of oral pain caused by oral mucositis associated with chemotherapy or radiation therapy, and coating and protection of oral lesions
Pain relief may be expected within a few minutes
An exclusive Brazilian distribution rights licensing agreement was concluded in August 2025. We hold the exclusive worldwide manufacturing and marketing rights for episil and expect to generate revenue going forward by supplying the product to Daiichi Sankyo Brasil.
A wholly owned subsidiary of DAIICHI SANKYO COMPANY,LIMITED, headquartered in São Paulo, Federative Republic of Brazil.
The ANVISA filing number for the start of sales was published on 13 July 2026 (the filing number itself is Not disclosed). The validity period is Not disclosed.
Projected revenue from product sales in Brazil has already been incorporated into the consolidated earnings forecast for the fiscal year ending December 2026. Milestone revenue is expected to be received from Daiichi Sankyo Brasil and recorded in the financial results for the third quarter of fiscal 2026. The amount of milestone revenue is undisclosed.
The company does not address Contract Value / Offering price.
Brazil’s National Health Surveillance Agency (ANVISA)
| Item | Details |
|---|---|
| Names of Products / Services Covered | episil®, epifilm |
| Counterparty | Daiichi Sankyo Brasil Farmacêutica Ltda. |
| Counterparty overview | A wholly owned subsidiary of DAIICHI SANKYO COMPANY,LIMITED, headquartered in São Paulo, Federative Republic of Brazil. |
| Relationship with the Company | An exclusive Brazilian distribution rights licensing agreement was concluded in August 2025. We hold the exclusive worldwide manufacturing and marketing rights for episil and expect to generate revenue going forward by supplying the product to Daiichi Sankyo Brasil. |
| Contract Date | August 2025 (exclusive Brazilian distribution rights licensing agreement) |
| Launch date | Sales scheduled to begin in the fourth quarter of 2026 |
| Applicable area | Management and relief of oral pain caused by oral mucositis associated with chemotherapy or radiation therapy, and coating and protection of oral lesions |
| Registration number and expiry date | The ANVISA filing number for the start of sales was published on 13 July 2026 (the filing number itself is Not disclosed). The validity period is Not disclosed. |
| Quantitative Effects | Pain relief may be expected within a few minutes |
| Impact on Business Performance | Projected revenue from product sales in Brazil has already been incorporated into the consolidated earnings forecast for the fiscal year ending December 2026. Milestone revenue is expected to be received from Daiichi Sankyo Brasil and recorded in the financial results for the third quarter of fiscal 2026. The amount of milestone revenue is undisclosed. |
| Source | Brazil’s National Health Surveillance Agency (ANVISA) |
Items this document does not state (7)
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.The filing to begin sales was published by Brazil’s National Health Surveillance Agency (ANVISA), making the product eligible for sale under Brazil’s medical device regulations.