Benefits at a glance
- Niche Product
- High Flexibility with the business model
- Dossier already submitted in the US
- Development Kick-off
- Formulation Development
- Pilot BE
- Scale Up
- Pivotal BE
- 6 M Stability
With our Nelarabine-Dossier, we can offer access to a dossier, which has been successfully submitted in the US (Aug. ’22).
The dossier can be shortly updated to meet EU-standards, as the supply chain (manufacturing site and API-supplier) are EU-GMP certified.
With approximately 20.000 yearly diagnoses of T-Cell leukemia, our Nelarabine-Dossier can provide patients with an adequate treatment option and unlock significant market potential with strong year over year growth rates (> 50 %) and limited competition.
Business Development & Licensing
The exploitation, including the development, sale and offer for sale of products and related processes is performed by Midas only in those territories where permissible by applicable patent law in particular, but not limited to EC Directive 2001/83 EC, Article 10, as amended by EC Directive 2004/27 EC. This document, therefore, does not and shall not constitute an offer for sale for the product in territories where an offer for sale or sale is not permissible by law. Midas expressly disclaims any liability for the information provided in this document as well as for damages resulting from or arising out of the use of the product and related process for purposes other than research and development in compliance with applicable laws.