Announced details
Treatment of Duchenne muscular dystrophy (DMD)
Already approved in several countries, including the United States, the EU and the United Kingdom. The number of patients in Japan is estimated at approximately 3,500.
The parties have entered into an exclusive licensing agreement for the development and commercialization of givinostat in Japan.
An unlisted global pharmaceutical company founded in Milan, Italy, in 1938. It conducts pharmaceutical research, development, manufacturing and commercialization in more than 90 countries, directly or through affiliates.
Orphan drug designation, priority review designation
Ministry of Health, Labour and Welfare
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Kawai Mitsuru (川井充), “How Many Duchenne Muscular Dystrophy Patients Are There in Japan?”, and other references 1–6
| Item | Details |
|---|---|
| Names of Products / Services Covered | givinostat, Duvyzat® |
| Counterparty | Italfarmaco S.p.A. |
| Counterparty overview | An unlisted global pharmaceutical company founded in Milan, Italy, in 1938. It conducts pharmaceutical research, development, manufacturing and commercialization in more than 90 countries, directly or through affiliates. |
| Relationship with the Company | The parties have entered into an exclusive licensing agreement for the development and commercialization of givinostat in Japan. |
| Contract Date | December 2025 (last December) |
| Applicable area | Treatment of Duchenne muscular dystrophy (DMD) |
| Award/certification name | Orphan drug designation, priority review designation |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Usage history | Already approved in several countries, including the United States, the EU and the United Kingdom. The number of patients in Japan is estimated at approximately 3,500. |
| Source | Kawai Mitsuru (川井充), “How Many Duchenne Muscular Dystrophy Patients Are There in Japan?”, and other references 1–6 |
Items this document does not state (8)
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.Because it received the designation from the Ministry of Health, Labour and Welfare. The company said the designation is an important milestone toward commercialization of the drug and will help provide treatment to DMD patients in Japan at an early stage.