Therapy Area Review and Prioritization of Opportunities

Management Challenge

Our client, a clinical-stage biopharmaceutical company, was heavily dependent on and known for one therapeutic area (TA). They had a number of assets in pre-clinical development with potential in a several different diseases in a new therapy area and wished to broaden their development portfolio accordingly but needed help in evaluating and prioritizing the best disease opportunities to pursue in terms of scientific rationale, unmet medical need and commercial potential.

Engagement

Psscion worked collaboratively with the client, including facilitating two workshop sessions, to comprehensively review 8 disease areas and build Target Product Profiles (TPP’s) for each including forecasts of peak sales potential and key clinical, regulatory and reimbursement/access hurdles to be addressed with an overall probability of success agreed. Key elements included:
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Benefits and Outcomes

Three disease areas/ TPP’s were prioritized to move into development. These, supported by the above analysis, were presented to the Client’s Board of Directors and endorsed/ funded to be taken forward into development. In one disease area where we have particular expertise, we were also asked to provide recommendations for rapid (max 28 day) proof of principle studies to quickly confirm human efficacy together with suggested KoL’s/ Centers to conduct such studies. The Client issued a press release announcing their entry into the new TA/DA’s and subsequently acquired rights to an additional library of compounds complementary to their own internal assets.

Strategic Assessment of In-Licensing Opportunities

Management Challenge

A large multi-national devices company wished to diversify their business and add a range of pharmaceutical products which would complement their device portfolio and also help mitigate against competitive threats and challenges in the US and global healthcare environment which were threatening their core business. Business Development had identified two potential in-licensing opportunities and required expert help in evaluating the development risks, competitive/ generic threats and commercial potential of each.

Engagement

Psscion reviewed the competitive landscape and market environment anticipated at time of launch. In this context, we developed Minimum and Upside Product Profiles for the key acute and chronic indications and compared the two potential in-licensing candidates against these. We identified significant areas of opportunity (even though our forecasts were only 40-50% of the out-licensing companies), but also significant challenges facing each asset. In particular, we showed that the Ph III failure rate in this area was significantly higher than industry norms and that timing of entry of a generic version of the current market leader was a key driver of value (approval and launch of either in-licensing candidate later than this would be unlikely to achieve break-even).

Benefits and Outcomes

While development of either asset for the chronic indication market was an excellent strategic fit for the client, neither came close to achieving the ideal profile. Given the high Ph III failure rates and generic threats the Client agreed with our recommendation not to pursue either candidate but to seek assets that came closer to the ideal profile with a greater chance of clinical and commercial success. We are assisting them in that search. As a young organization within an established company, they cannot afford to fail with their first foray into pharmaceutical Phase III development.