Securing EMEA registration for cancer treatment averts a costly clinical trial

Class: Anti-Cancer

Revenue: < $1 billion

Patients: 5,000

Achievable ROI: $15-$75 million

IP Rights Status: Assigned to client

In preparation for filing for product registration in the European Union, a prominent oncology research group sought to compare the efficacy, toxicity, and safety profiles for its drug versus those whose results were published in leading clinical research journals. The drug was already approved for use in the United States and had a randomized controlled trial underway, but the client did not expect results for another eight years.

Our work involved culling through more than 2,000 journal articles in order to develop a comparator database of published clinical trial results. We then compared published results for key endpoints to those in the client’s clinical studies: complete remission rate, median relapse-free survival, and overall survival. Finally, we reported statistically validated measures of superiority and inferiority across all key dimensions.

Our meta-analysis report was submitted with the client’s product registration filing as evidence of results likely to emerge from the randomized controlled trial. Should the EU approve the product registration in its current form, the client will avert a costly clinical trial and launch its drug five years sooner than originally planned.

With the drug’s EU revenue projected to average $15 million per year, the achievable ROI for this client is conservatively in the range of $15–$75 million.