To build the foundation for execution of clinical trials and commercialization of the product with new trademark for orphan disease - uveal melanoma
Uveal melanoma is a rear disease. After brachytherapy about half of the patients develop metastases, in those patients, the 1-year survival is reported to be 15%. So far there is no standard treatment available.
The company is a manufacturer and producer of commercialized ECHO 7 virus, which has been used clinically in the designated indication. The preclinical data and observed outcomes are encouraging.
The commercialization foundation should be elaborated and started.
Estimated project cost
EUR 1.4 million
Industry for SMEs & Mid-Caps
Expected Jobs created
Economic rationale / Business Model
The company would create spin off for development of therapeutic agent for particular rear disease. Number of investors would be attracted to finance the development costs. After the commercialization of the medicine, the company will be either sold or the distribution would be licensed to existing market players with established network and focus on rare disease.
Project financing secured: EUR 0.196 million (14 %)
Financing source: Private
The planned funding of 1.2 million EUR, would be used to execute feasibility study, form corporate spin-off and form the team. During the feasibility study the company would finalise preclinical studies and clinical case reports. The EMA scientific/regulatory advice for orphan medicinial product will be received and the clinical trial protocol will be validated.
The promoter has applied or has the intention to apply for EU or EIB financing related to this project
Existing or potential bottlenecks for the realisation of the project / Potential risks
The existing researches show convincing results of efficiency of the medicine.
Lack of finance risk is rated as medium. The lead investor is needed. Depend on results additional investors would be searched and investment rounds initiated, the total investment is estimated in amount of 10 million EUR.
Operational risks are rated as low. The company has selected experienced management team with necessary experience and skills.
Project additional information
1. As per initial EMA/CHMP Scientific Advice ECHO-7 (Rigvir) - the available data are sufficient to enter clinical phase II (e.g. a proof-of-concept study).
2. The company holds for ECHO 7 a complete “freedom to operate” and all of the necessary patents to successfully operate in a market.
3. There are clear market incentives also from EMA including market exclusivity and reduced fees.
The Commission gives no warranty and makes no representation, whether expressed or implied, that the Project Information is error free. The Project Information is provided without any guarantees, conditions or warranties as to its accuracy.
A free translation into English has been provided by the European Commission on this project, for information purposes only. The original language version is the authentic version.