Johnson & Johnson to Challenge Novartis in Axial Spondyloarthrtis Treatment Space

Date: 2015-10-20

Johnson & Johnson’s (J&J) psoriasis drug, Stelara, has progressed into Phase III development for axial spondyloarthritis (axSpA) and, following its anticipated approval, is forecast to achieve impressive axSpA sales of $244.7 million in 2024, says research and consulting firm GlobalData.

The company’s latest report* states that Stelara, an IL12/IL23 inhibitor, has demonstrated a strong safety profile in other indications, and is expected to launch in the US and five European countries (France, Germany, Italy, Spain, and the UK) for the treatment of ankylosing spondylitis (AS) in H2 2020 and non-radiographic axial spondyloarthritis (nr-axSpA) in H1 2021.

According to Heather Leach, Ph.D., GlobalData’s Senior Analyst covering Immunology, the anticipated launches of Novartis’ Cosentyx, an IL17 inhibitor, and J&J’s Stelara will add new mechanisms of action (MoAs) to the existing axSpA treatment space.

The drugs will also command premium pricing, above that of the most frequently used anti-tumor necrosis factor (anti-TNF) biologics, helping to boost the global market value to $2.9 billion by 2024.

Leach says: “Stelara will compete most heavily with Novartis’ Cosentyx in treating patients who have failed at least one anti-TNF biologic or are intolerant to the therapy.

“Key opinion leaders interviewed by GlobalData expressed a preference for Cosentyx as a first-line therapy, if reimbursed, or following the first anti-TNF failure. However, Stelara is also in Phase III development for ulcerative colitis and Crohn’s disease, making it likely to be the preferred treatment option for patients with inflammatory bowel disease, a comorbidity frequently seen in axSpA.”

The analyst adds that while Cosentyx and Stelara will partially address the unmet need for therapies with novel MoAs, opportunities will remain for drug developers in this previously overlooked market.

Leach explains: “There are currently a limited number of drug classes in the AS therapy market, with Cosentyx bringing only the second MoA for use after non-steroidal anti-inflammatory (NSAID) drug failure. There are additional opportunities for companies to expand into nr-axSpA treatment, for which there are no approved biologics in the US.

“While Novartis’ Cosentyx and Celgene’s Otezla will have some limited off-label use in nr-axSpA, an approval will enable more widespread use. J&J released its plans in March 2015 to conduct trials for Stelara in both AS and nr-axSpA patients, and other companies are expected to follow this trend towards conducting trials earlier for nr-axSpA.”

*OpportunityAnalyzer: Axial Spondyloarthritis – Opportunity Analysis and Forecast to 2024 – Event Driven Update

This report provides annualized axial spondyloarthritis (axSpA) therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024, segmented by ankylosing spondylitis and non-radiographic axial spondyloarthritis. Key topics covered include strategic competitor assessment, market characterization, unmet needs, research and development strategies, clinical trial design, and implications for the axSpA market for branded drugs and biosimilars.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry experts.


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