Challenge

An incoming lead investor needed to assess a proprietary platform technology for the oral delivery of biological drugs.

Solution

Our life science due diligence team took on the project, whose scope included assessing the:

• strength of preclinical data in comparison, as far as data was available, with competing approaches
• IP ownership and likely strength of patent protection
• clinical and regulatory strategy and execution; key risks and likelihood of success
• competitor landscape, including direct and indirect competition
• market potential
• manufacturing feasibility, investment needs and likely COGS
• overall budget to reach product registration and market launch

Given the core strategy was to repackage existing drugs, several interlocking factors were analyzed:

• clinical and health outcome impact of switching from an injectable to an oral delivery system
• potential for premium pricing over established injectable product
• likely level of switching from injectable to oral product for existing patients
• likely level of penetration in the new prescriptions segment
• scope for broadening the market by taking share from alternative products

The project was undertaken and completed over a two-week period and provided the client with an insight into key technical, regulatory and commercial risks facing the company.