DUE DILIGENCE INSIGHT FOR INNOVATIVE OPHTHAMOLOGY PRODUCT
A global biopharmaceutical company is currently investigating a new opportunity, outside their main areas of focus and expertise. The therapy of interest has recently successfully completed Phase III clinical trials for an indication that is both poorly diagnosed and often untreated. Furthermore, this therapy is also a potential replacement for a highly invasive ophthalmologic procedure. The goal is to assist with a due diligence investigation through identifying both the potential use, and the unmet needs across regions within North America, Europe and Asia, by determining the therapy’s scope in terms of potential patients available. Additionally the company is looking to gain insight into an unfamiliar market, which has a heightened level of complexity due to the need for both efficacious therapies and suitable diagnostics in order for either to be commercially successful. Ultimately the company is keen to understand the opportunity of this potential acquisition.
With recent technological advances, the ability to image structures within the eye has improved immensely. However, the equipment required for this is not yet widely available, nor is the skill base established beyond a handful of specialists. Furthermore, due to the current lack of pharmacologic treatment for the target condition, a new market would need to be established. Due to the lack of accurate and established diagnostic methods within this indication, it was also problematic to identify and size the relevant population of interest.
A combined approach was used to generate a range of relevant populations upon which to base an investment decision. In addition to information obtained from national medical surveys, which enabled estimation of prevalence rates for indications linked to the one of interest, peer-reviewed publications were also used to gauge the most recent developments within the field. Firstly, through identifying high-risk groups both with and without visual impairments, these groups were then filtered such that three distinct eligible treatment populations were calculated. Also, in countries where suitable data was available, estimates of diagnosis rates and numbers of surgical procedures performed were overlaid to the eligible treatment populations. This produced a higher level of understanding of the disease area and provided further insight into current clinical practice.
Results & feedback
Within four weeks, Black Swan Analysis was able to identify and collate the patient populations both currently receiving related therapies and those who, with this innovative therapy, could receive treatment for a currently untreatable condition. Furthermore, the challenge associated with identifying relevant patient populations was informative as to the current medical diagnosis and treatments widely practiced. This insight helped to tailor the final stages of the due diligence investigation and supported the development of a business case, which included the clinical speciality to target as well as the diagnostic opportunity available. The client is currently completing their due diligence assessment in order to establish if the addition of this product to its portfolio is of significant commercial benefit.