Due diligence and asset valuation

Biotechnology companies continue to drive innovation at the frontlines of pharmaceutical research and development. The continued growth of this industry is, in part, supported by partnerships, mergers and acquisitions where portfolios of assets are continually acquired or divested. Organisations and investors need to understand the value and risks of assets from a developmental, regulatory and commercial perspective.

For investors thinking of investing in an asset or series of assets we take a holistic look at all the data the sponsor has generated and interpret that in the wider context of the proposed target product profile, current standard of care and the potential pathway to regulatory approval and reimbursement. This involves the coordination and collaboration of multiple subject matter experts within ICON

ICON can increase efficiency in this process by assisting biotechnology companies with portfolio prioritisation and technical and commercial evaluation of out- or in-licensed assets. These services include preclinical review of:

• Pharmacology
• Toxicology
• Drug metabolism
• Toxicokinetics
• Clinical pharmacology
• Dose justification
• CMC
• Regulatory
• Clinical
• Commercial assessment, including forecast and NPV development

ICON has experience reviewing regulatory, pre-clinical, CMC, clinical and commercial information on behalf of many biotech and investment clients for the purposes of acquisition, partnership, divestment or investment.

Our due diligence process consists of a three stage approach which can either be stand-alone or sequential

• Triage: A small team of experts, usually one or two individuals, will assess high-level information which is available in the public domain to determine whether there is a potential opportunity for an asset.
• Stage one: Evaluation is performed by a more extensive team of experts, usually involving the assessment of confidential information provided by the sponsor or investor.  One of the objectives is to highlight areas for further deeper diligence
• Stage two: Subject matter experts will conduct a detailed analysis of the key risks (often highlighted in earlier diligence reviews) to fully assess the opportunity for deal structuring.  This usually involves a full confidential data room

Asset valuation

When it comes to valuation of the cost of development or assessment of a product’s market potential, our team has assessed more than 100 assets in over 40 indications across 14 therapeutic areas. These assets have spanned a variety of modalities including small molecules, biologics, regenerative medicines and vaccines, in addition to medical devices.

Pricing and market access

With over 650+ product launches, ICON provides in-depth pricing, market access, and reimbursement expertise with integrated, cross-functional health economics, medical and value communications, patient-centred outcomes, real world evidence, regulatory and clinical teams to define, capture and communicate the value of novel medical therapies for optimal commercial results and greater patient access.