Challenges of Funding the Late Phase Clinical Development – Gaining Market Authorization and Access for Repurposed Drugs

Traditional drug discovery and development is a time-consuming, labor-intensive, expensive and risky process.

Drug repurposing has the potential to reduce the risk of failure in the development phase, shorten time to market and reduce development costs accordingly.

Although the European Commission facilitates and encourages the repurposing of medicines, e.g. the Horizon grants are not large enough to set up the registration studies required by the European Medicines Agency (EMA), value dossiers required by payers and large-scale production. The potentially clinically and socially valuable repurposed medicines that achieve a PoC may never reach patients, because these consortia lack the expertise and resources to prepare the products for market approval, reimbursement, production, distribution and medical education.

Pharmaceutical companies typically opt for innovative products with strong patent protection and the potential for high prices.

The goal of VCs is not to get a product onto the market, which costs tens to hundreds of millions of euros and exceeds the investment capacity of most VCs.

The major challenge for fully developing repurposed medicines and making them available to patients, is financing them.