Announced details
Acute spinal cord injury
10 years of market exclusivity in the EU and fee reductions from the EMA
The Company has obtained orphan medicinal product designation from the EMA for the medicine it is developing. Capital and personnel relationships are not disclosed.
European Medicines Agency (EMA). Other details, including its location, representative, capital and year of establishment, are not disclosed.
Orphan Medicinal Product Designation
European Medicines Agency (EMA)
10 years of market exclusivity in the EU. The registration number, designation date and other validity details are not disclosed.
The Company stated that the designation will provide a significant advantage in negotiations with pharmaceutical companies regarding partnering and in obtaining grants, but the specific impact on financial results is not disclosed.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | oremepermin alpha (recombinant human HGF protein) |
| Counterparty | European Medicines Agency (EMA) |
| Counterparty overview | European Medicines Agency (EMA). Other details, including its location, representative, capital and year of establishment, are not disclosed. |
| Relationship with the Company | The Company has obtained orphan medicinal product designation from the EMA for the medicine it is developing. Capital and personnel relationships are not disclosed. |
| Applicable area | Acute spinal cord injury |
| Award/certification name | Orphan Medicinal Product Designation |
| Awarding / certifying body | European Medicines Agency (EMA) |
| Registration number and expiry date | 10 years of market exclusivity in the EU. The registration number, designation date and other validity details are not disclosed. |
| Quantitative Effects | 10 years of market exclusivity in the EU and fee reductions from the EMA |
| Impact on Business Performance | The Company stated that the designation will provide a significant advantage in negotiations with pharmaceutical companies regarding partnering and in obtaining grants, but the specific impact on financial results is not disclosed. |
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.The designation is granted to medicines targeting diseases affecting no more than 5 people per 10,000 in the EU that are life-threatening or chronically debilitating and provide a significant therapeutic benefit over existing treatments. The Company stated that obtaining the designation will enable it to take advantage of development and commercialization incentives and accelerate global development.