Providing due diligence of a novel drug formulation

Challenge

An established medical device company looking to make a strategic investment needed commercial, regulatory, IP and technical due diligence on an investment opportunity in the diabetes therapy area.

Solution

For the commercial due diligence, we undertook both US and EU market assessments through literature review and primary research with clinicians and patients. The resulting market forecast revealed that the product’s market potential was substantially lower than previously thought. We reviewed the company’s regulatory strategy for 505 (b)(2) regulatory approval in the US and identified a number of additional areas that needed to be addressed in the development plan. During the IP analysis, we concluded that significant work would be necessary for the product to be considered novel or inventive given the state-of-the-art therapy at the time.

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