In-licensing due diligence for a respiratory drug

Challenge

A pharma company needed help conducting due diligence on an in-licensing/acquisition candidate for a Phase IIb respiratory drug.

Solution

Our expert respiratory physician, who had a wealth of big pharma and biotech drug development expertise, reviewed the available documentation, including:

• investigator brochure
• clinical study reports and publications of data from two completed clinical studies in a target indication
• clinical protocol and statistical analysis plan for the ongoing Phase IIb clinical trial
• feedback from the European Scientific Advice Working Party concerning paediatric development and from the FDA in response to an IND submission for the Phase IIb protocol

We concluded that the ongoing Phase IIb would have, at best, modest improvement in clinical performance and the drug would likely generate significant adverse events. We advised the client that in-licensing of the product should only be considered if the results provided more compelling evidence of clinical effectiveness than those available to date. The pharma company did not proceed with the transaction and the Phase II trial later failed to meet its primary endpoint.