Systemic Lupus Erythematosus - Identifying and Commercializing First-in-Class Innovation

Thursday 30 January 2014, Amsterdam

Anticipation of Highly Efficacious Therapeutics Emerging from the Pipeline

The Systemic Lupus Erythematosus (SLE) market is currently under-served by targeted therapies. Whilst the only Food and Drug Administration (FDA) approved biologic, Benlysta (belimumab), generated sales of $111m in 2012, there is little evidence that the drug’s performance is significantly superior to other B-cell targeted therapies such as Rituxan (rituximab), where unlicensed use is commonplace for refractory SLE patients. Therapeutics entering the market do not face the level of competition from currently marketed programs as in other markets such as the Rheumatoid Arthritis (RA) market. Emerging market entrants that appear to offer significant therapeutic benefits are likely to cause dramatic change to the market landscape.


Highly Diversified Range of Innovative Programs in the Pipeline

Although the SLE pipeline comprises only 74 active developmental programs, over 67% of these programs are biologics and around 31% involve first-in-class molecules. Only a very small number of products are repositioned from other indications and there is also a high level of diversity in terms of novel therapeutic targets. Innovative programs also target molecules that have only recently gained recognition as having therapeutic value in the treatment of SLE. However, some of these programs have only been validated in animal models and therefore require further clinical assessment in order to establish how they compete against established antibody and small molecule disease-modifying therapies. Other first-in-class programs have advanced to late-stage clinical trials.

A growing understanding of the signaling pathways underlying SLE pathophysiology including, but not limited to, B cells, T cells and intracellular kinases is being translated into a higher number of novel targeted therapeutics entering the developmental pipeline. However, a high level of sustained investment in the development of cytokine blocking strategies is present, as therapies targeting the interferon pathway are relatively common in the pipeline.  


Sparse Licensing Deals and Co-development Deals Landscape  

Sharing financial and developmental risks between pharmaceutical companies is a highly desirable strategy in SLE drug development, and in many cases, critical to the success of companies with limited financial resources. Although the licensing and co-development deals landscape is relatively small as an indication by industry standards, many high-profile developmental programs have been involved, particularly where licensee companies have yet to generate stable net income.

In the licensing agreement landscape, developmental drugs that inhibit intracellular kinases targeting therapies have fetched the highest valuations. It is likely that their commercial attractiveness is due to several reasons, such as their clinical efficacy in the treatment of diseases. Additionally, this could be due to the fact that kinase inhibitors are under-served in the current SLE market, which presents minimal barriers to market entry. This also appears to be the case for B and T cell targeting therapies. Interestingly, the co-development landscape is saturated with biologics, all of which target cytokines and lymphocyte antigens and many of which are first-in-class, thus indicating a high level of commercial appeal in innovative therapies.