Frontier Pharma: Breast Cancer – Identifying and Commercializing First-in-Class Innovation


Exceptionally Large and Innovative Pipeline

The breast cancer pipeline is the largest in the pharmaceutical industry with 815 products in active development across all stages. The range of mechanisms of action employed by these compounds is also highly diverse, especially in comparison to the existing market landscape. More pertinently, the degree and proportion of breakthrough innovations in this pipeline is exceptional; GBI Research analysis identified 253 first-in-class programs in the breast cancer pipeline, acting on 176 first-in-class molecular targets. This accounts for some 39% of all products with a disclosed molecular target and is reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high attrition rate in breast cancer, it is highly likely many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.

Alignment of First-in-Class Molecular Target with Disease Causation

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One of the key trends in oncology and in breast cancer in particular over the last decade is the clinical and commercial impact of targeted therapies designed to target proteins in signaling pathways that are frequently mutated in a significant proportion of the patient population. By aligning the molecular targets for therapeutic intervention with disease causation and/or propagation, these therapies limit the systemic cytotoxic effects whilst inhibiting tumor-promoting signaling pathways. Such strategies thereby typically achieve superior efficacy and safety profiles.

Our proprietary analyses demonstrate significant levels of differentiation as to how well the first-in-class products and their respective molecular targets align to underlying gene and protein level mutations and dysfunction. More advanced analytics further substantiated these findings as strong levels of differentiation in the scientific and clinical rationale for first-in-class molecular targets emerged. Furthermore, clear frontrunners were identified by integrating analyses to assess the accessibility of molecular targets for therapeutic compounds, the size of the target patient population that would benefit from therapeutic intervention, and the expected positioning of the first-in-class products based on the molecular targets and mechanisms of action of currently marketed products.

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These insights and a detailed review of the available evidence from scientific studies substantiate the perspective that first-in-class-product technology in its own right is not sufficient to offer a compelling scientific and clinical rationale. However, a range of products offer very significant scientific and clinical promise and could therefore result in a strong commercial proposition with the prospect of clinically and commercially transformative products in the future.

A Highly Active Deals Landscape with Numerous Investment Opportunities

The breast cancer deals landscape is highly dynamic, with both deal number and aggregate value exceeding industry benchmarks, reflecting the large and highly competitive marketed and pipeline product environments. Moreover, with 40 first-in-class products that are currently in development having been involved in a licensing or co-development deal, the capital being committed to breast cancer partnership deals is not limited to products with established mechanisms of action in the marketed product landscape. On the contrary, breakthrough innovations are highly desirable as an investment option. Analysis shows that the licensing deal values can exceed the mean and median deal values for licensing deals in Phase I, II and III, suggesting that premium deals can be achieved by smaller firms with the capacity to advance strong products to one of the clinical stages of development. However, most deals involving first-in-class products were either preclinical or Phase I development, whereas advance-in-class and addition-to-class product deals were typically made in Phases II and III, therefore showing significant differentiation. These findings have significant strategic implications for both biotech companies seeking to out-license products and firms with an interest in in-licensing first-in-class products with strong clinical and commercial prospects.

With the remaining 213 first-in-class products that are currently in development having not yet been involved in a licensing or co-development deal, there are numerous opportunities for in-licensing or co-development in this indication, which already has a strong track record of breakthrough innovation yielding highly commercially and clinically successful therapies. Although many act on targets that are not yet strongly substantiated in terms of their therapeutic potential in breast cancer in clinical studies, there are many which are supported by very robust and promising in vivo and in vitro preclinical evidence, and as such are highly promising breast cancer therapies.

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