Xzencis support for Mergers & Acquisitions

A successful outcome for merger and acquisition (M&A) along with licensing negotiations in the pharmaceutical industry much depends on Due Diligence.

The translational, integrative, overall safety evaluation of a licensing opportunity or a target company’s R&D pipeline makes and breaks deals as much as the therapeutic claims. ‘Translational’ means integrating all relevant data and information, irrespective of the source, towards a concise quantitative safety and risk profile of an asset, likely R&D outcome, and market performance.

As such, a rigorous Translational Safety assessment is a critically important value carrier for the scientific/medical, commercial, and strategic outcome of deal-making and nowhere else is Translational Safety more demanding, condensed, and immediately impactful.

Hidden safety pitfalls

Anticipated or established therapeutic product claims and market scope are usually well-documented and presented to potential buyers, licensees and investors. For preclinical projects, the bioscience/pharmacology expert(s) or the clinician for clinical development projects are usually very well informed.

The situation for safety is often a totally different matter, especially for clinical-stage projects. Relevant information is usually scattered across various different in-house disciplines and outside sources and is rarely presented in a concise, well-integrated manner. During a Due Diligence exercise, an interested party is usually presented with isolated pre-clinical and clinical safety data sets discipline-by-discipline, with little integration, leave alone overarching conclusions.

The translation of identified scientific, medical and strategic safety issues into the valuation process, e.g., quantifiable financial risks and commercial impact, is usually made in a rudimentary fashion, largely due to a lack of expertise in translating pharma R&D content into financial and commercial terms. Validity of the scientific/medical and strategic claims is usually taken as an indicator of the soundness of the investment or purchase, the commercial prospects and appealing valuation. However, this can be grossly misleading since it takes little account of long-term implications across the product’s whole life cycle and potential product mutations.

Benefits of a Translational Safety approach

Companies seeking to outsource or license assets have much to gain by including a concise Translational Safety workstream when preparing their data sets, documents, and presentation for evaluation by external parties. Investors, banks and other funding parties (e.g., public funding institutions) of acquisition and licensing agreements are well advised to seek a qualitative and quantitative assessment of safety risks relative to their financial contribution or investment.

A comprehensive, integrated safety evaluation will dramatically increase the chances of attracting relevant, interested parties and securing a commercially attractive deal. Furthermore, a sound and thorough Translational Safety assessment and summary adds to the transparency of data packages and safeguards against later complaints.

Companies interested in acquiring or licensing assets benefit tremendously from a deep, concise, and integrative assessment of safety aspects and a safety-focused evaluation of an asset’s underlying assumptions, concepts and strategy. For individual assets, Translational Safety can replace nonclinical drug safety and patient safety/pharmacovigilance experts on the evaluation team.

For larger portfolio assessments, Translational Safety should be tasked with managing such experts toward an integrated assessment and outcome. A good Translational Safety Assessment is thus a key component in ensuring the value, fit, and prospects of a licensing deal or acquisition.

Xzencis Investor Support

Xzencis is one of a select few companies able to offer fully integrated pre-clinical and clinical safety assessments and services,  as well as integration into the valuation process. We are highly distinctive in our ability to translate respective results from a pharma R&D environment into qualitative and quantitative financial and commercial content than is transparent for investors and financial advisors.

The particular strength and expertise of Xzencis lies in its integrated, translational approach to safety, with a focus on planning and executing transitions from the pre-clinical space into patient and clinical safety.

In this endeavor, Xzencis can integrate data, information and objectives from all relevant sources and functions, including essentially: non-clinical drug safety (NCDS), drug metabolism and pharmacokinetics (DMPK), , pharmacology/bioscience, clinical and patient safety and competitor product assessment.

An Xzencis translational assessment always aims to compile an incremental, evidence-based build of a competitive, value-carrying product safety profile.

For investors, Xzencis can review and quantitively assess risks of a drug project or product opportunities from pre-clinical to completed Phase II trials as well as repositioning projects at any stage. It can therefore translate all identified or potential safety risks into quantitative and qualitative financial terms.

Resources

Click on Xzencis translational safety services for further information.