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Physician Views: What opportunity beyond the anti-TNFs in rheumatoid arthritis?
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Published by FirstWord Pharma: 18 Mar 2013 | 108 | In Stock
Related Topics: Enbrel , Humira , Lilly , Novartis , Pfizer , Pharmaceuticals , Roche



Last week, FirstWord identified Bayer and Johnson & Johnson's anticoagulant Xarelto as the industry's leading product-level sales growth driver in 2013. Furthermore, in announcing its Q4 results, Bayer increased its own peak revenue forecast for the drug, from around .7 billion to approximately billion.

Xarelto has defied commercial expectations, particularly regarding how it has fended off competition from Bristol-Myers Squibb and Pfizer's Eliquis, which is widely considered to have the best clinical profile among the new generation of anticoagulants.

FirstWord's recent list of the best-selling drugs in 2013 once again illustrated the commercial 'footprint' of the anti-TNF inhibitors, and in particular the three biggest-selling drugs in this class – Humira, Remicade and Enbrel. Positioned as three of the four best-selling drugs in 2013, they contributed combined revenue of around billion.

A key facet relating to both the commercial and clinical profiles of these products is their longevity, with Enbrel and Remicade both launched in 1998 and Humira launched in 2002.

From a clinical perspective, physicians have gained much experience in using these products, which has greatly helped to entrench them as the gold-standard second- and third-line therapy in rheumatoid arthritis (RA) patients behind methotrexate. Commercially speaking, the biologic status of these drugs has extended their lifecycles beyond those associated with a small-molecule product, indicating that impressive annual revenue expansion will be delivered for some time.

Herein lies something of a paradox for developers looking to access the RA market. To gain significant market share in the second- or even third-line settings a new treatment would be required to demonstrate notable superiority to the likes of Humira, Remicade and Enbrel that would need to be sufficient to trigger a paradigm shift in the way that rheumatologists treat RA.

Simultaneously, however, the scale of revenues generated by the anti-TNFs provides a tantalising commercial prospect for developers, albeit if a new product was to gain the majority of use in third-line RA patients.

But is the market opportunity for alternative biologic RA therapies – both already marketed (such as Bristol-Myers Squibb's Orencia and Roche's Actemra and Rituxan brands) and those in the late-stage pipeline (such as Eli Lilly's baricitinib, Regeneron Pharmaceuticals/Sanofi's sarilumab, Novartis' secukinumab or Johnson & Johnson's sirukumab) – likely to evolve significantly in the short to medium term?

The slower-than-expected launch of Pfizer's Xeljanz – touted as a potential anti-TNF competitor, but offering the convenience of oral availability – demonstrates just how entrenched the leading anti-TNFs are, particularly given the evidence to suggest that the injectable nature of these drugs is a notable barrier to even broader uptake.

Puchase Reasons

To help answer these questions, this week's Physician Views poll asks rheumatologists based in the EU5 and US...

  • How many anti-TNF therapies an RA patient typically fails before they progress onto an alternative biologic therapy?

  • What their preferred non-anti-TNF therapy is in this instance?

  • What their primary reason is for selecting this product?

  • Based on their knowledge of the current treatment landscape and late-stage R&D how they expect the market for biologic RA therapies to develop over the next decade?

  • Excluding the emergence of a therapy that delivers a compelling efficacy/safety benefit over the anti-TNF products, what scenario they think would most likely see them increasingly usage of an alternative product in favour of an anti-TNF in RA patients progressing beyond methotrexate?

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