Skip to content

Indication extension opportunities case study

Extending marketed products into new indications with high market value and faster route to approval

Background

Our partner, a mid-sized pharmaceutical company facing a modest patent cliff in its marketed products, wanted to maximize the value of its patented assets by identifying new commercial opportunities for its approved drugs and candidates.

The company specializes in two therapeutic areas encompassing multiple indications.

INDX case study mineralocorticoid receptor-2

Indication extension opportunities

We performed a systematic analysis of our partner's pipeline and marketed assets, mapping these to our unique mechanistic disease insights. These included NR3C2 - the gene target for MR antagonists.

We analyzed NR3C2 in our DiseaseBank to identify clinically relevant patient subgroups where the use of MR antagonist may be an effective therapeutic option.

In one such group, a combinatorial disease signature containing a variant in NR3C2 was identified to be highly associated with type 2 diabetes patients who have developed at least one of the main complications associated with diabetes.

Our analysis suggests that the use of MR antagonists may be beneficial to type 2 diabetic patients who are most at risk of developing renal complications according to their genetic data.

Indication-extension-example-patient-stratification-biomarker-p1

6

priority indication extension assets in key therapeutic areas

2

marketed drugs with precision repositioning opportunities 

5

additional repositioning assets validated for out-licensing

Outcomes and impact

We evaluated each opportunity to prioritize those with the highest market value and easiest route to approval.

In total, we identified 6 priority opportunities to reposition assets in high-value indications within the company’s key therapeutic areas. These opportunities were mainly in late-stage trials with an already established safety profile and two of the opportunities were for drugs already approved and on-market.

The analysis also revealed 5 opportunities for the company to reposition their assets in other non-core therapeutic areas, potentially as out-licensing opportunities with other biopharma partners.

Each opportunity included a detailed multi-parameter evaluation, supporting data package with patient stratification biomarkers, and high efficacy prediction scores to minimize the risk of expensive trial failures due to efficacy and enable effective new treatments to get to market quicker.

Quote icon

You've identified genuine opportunities to expand our patented assets into high need indications.

With your companion biomarkers this will not only create new revenue but also reduce our development risk and bring effective new treatments to patients faster.

SVP Lifecycle Management

Indication extension

Maximize portfolio returns

Precision repositioning with companion stratification biomarkers

Learn more

Discover your indication extension options

Contact us