Novartis eyes psoriasis dominance with new approvals for Cosentyx

Novartis Pharma Chief David Epstein

Novartis ($NVS) is building the foundation for an anti-inflammatory powerhouse. Its blockbuster psoriasis contender Cosentyx scored FDA and European approvals this week, and it's armed with head-to-head data besting its older rivals. But the Swiss drugmaker could face a few stumbling blocks on its journey to the top of the psoriasis heap, as rival companies develop their own new therapies and existing drugs challenge its bid for market share.

The company's Cosentyx (secukinumab) is forecast to top $1 billion in sales by 2020, but it will have to compete with entrenched drugs such as AbbVie's ($ABBV) top-selling Humira, Amgen's ($AMGN) standout drug Enbrel and Johnson & Johnson's ($JNJ) Stelara. Humira had an estimated $12.6 billion in sales last year, while Amgen and Pfizer's ($PFE) together brought in about $8.4 billion in Enbrel revenue in 2014. J&J's Stelara raked in $2 billion in worldwide sales. AstraZeneca ($AZN) and Eli Lilly ($LLY) are also hard at work on psoriasis candidates that, like Cosentyx, are expected to change the standard of care for the disease.

Cosentyx is obviously first to the next-generation market, an important advantage, and its game-changing formula gives it a strong case against already approved rivals. Older psoriasis drugs such as AbbVie's Humira and Amgen's Enbrel target a protein called TNF that signals the body to create inflammation, and Stelara targets proteins known as IL-12 and IL-23. Cosentyx blocks an inflammation-related signaling protein called interleukin-17 (IL-17) to reduce symptoms of psoriasis, the first drug of its kind cleared to treat the disease. A National Psoriasis Foundation survey found that 52% of patients surveyed are dissatisfied with their disease management, suggesting a sizeable market opportunity for Novartis and its IL-17 blocker.

Plus, Cosentyx has already chalked up victories against its competitors. The Novartis drug beat out blockbuster Enbrel at improving symptoms of psoriasis in a Phase III study released in July, with more than half of Cosentyx patients reporting skin clearance rates of 90% or more, compared with 20.7% of Enbrel patients. In December, Cosentyx outperformed J&J's Stelara in a Phase III trial, meeting its primary goal of reducing psoriasis symptoms by at least 90% at 16 weeks.

"The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis," Novartis pharma chief David Epstein said in a statement. "This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin."

Pfizer and Amgen's Enbrel

Meanwhile, other companies are posting promising results for their own psoriasis therapies. In August, Eli Lilly's candidate ixekizumab surpassed Enbrel in a Phase III study. In November, Amgen and AstraZeneca charted their third straight Phase III win for brodalumab in plaque psoriasis, beating out J&J's Stelara in a head-to-head study. But both drugmakers are still waiting on stateside and European approvals for their products. Merck ($MRK) is also working on its IL-23-blocking tildrakizumab in Phase III studies.

- read Novartis' statement

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