Assessing oral delivery of biopharmaceuticals

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.

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