Pharmaceutical Opportunities : A three-step repositioning model for evaluating market options

Abstract: Pharmaceutical industry is today struggling with its productivity as products keep failing after long and expensive development programs. The protability is further threatened by erce competition from cheaper product copies. As an attempt to increase the pipeline output, pharmaceutical companies have lately turned to the strategy of drug repositioning. By applying an already developed drug in new disease areas the lifetime of the product is prolonged and return time on already made investments elongated.  Such development is imbued by less risk than a de novo development and has proven to be a faster and cheaper way to meet the medical demand. With limited company budgets and the often many repositioning possibilities, an informed repositioning selection must be made. As such theoretical model is not publicly available this thesis takes on the task to determine which parameters to take into consideration and how these should be weighted in relation to each other in order to evaluate di erent drug repositioning possibilities. Six main topics are identied to a ect the repositioning success, these are: medical need, economic return, scientic support, timing, life cycle extenders and external relations. These ndings are derived from empirics collected during interviews with employees from ve di erent competence areas involved in repositioning initiatives, na mely: research & development, clinical studies, regulatory a airs, pricing, and commercial. By further support from literature within the elds of drug repositioning and R&D project selection a three-step repositioning model was developed. The first step in the three-step repositioning model consists of primary parameters, these are essential parameters that have to be fullled in order to perform a repositioning strategy. If any of the primary parameters are not fullled, the repositioning opportunity should be killed in a go/no-go decision. In a second step, the secondary parameters are evaluated in a scoring model in order to determine the economical outlook of each repositioning opportunity. The opportunities showing greatest economical outlook should further be evaluated in the third and nal step in the three-step repositioning model. In this nal step the di erent repositioning opportunities are evaluated by their coherence with an overall corporate strategy. By applying this repositioning model to a repositioning selection scarce company resources  ay be focused on the repositioning opportunities showing best future prospect. Evaluating the potential of repositioning opportunities in a structured way should also increase chances to succeed. If successful, a repositioning initiative may a ect both company and society as the company improves return on earlier investments, while more patients in need of treatment will receive access to it. However, the three-step repositioning model presented in this thesis should be tested for more cases and perhaps be complemented with additional parameters or di erent gradings in order to optimize the selection.