We focus on the development of:
- New indications of known chemical entities for orphan diseases
- Improved medicines for already approved orphan medications
The development of such NTEs provides the advantage that safety and toxicology profiles are established and thus eliminates the risky proposition of dealing with new chemical entities. Further advantages are possibilities for shortened development timeline, shortened regulatory route (e.g. 505(b)(2) in US), development incentives, and overall faster time-to-market.
Our development focus is products that matter for our stakeholders, namely products that address unmet patient needs, that payers will reimburse and that doctors will prescribe. We are confident that we can achieve commercial opportunities similar to orphan drugs based on new chemical entities.
We have the key infrastructure in place to deploy our strategy. We have a very lean, but effective team with key competences in Drug Development, Regulatory Affairs, Business Development & Commercialization, Medical, Quality Management as well as Logistics, Supply Chain & Customer Service.