Novartis ($NVS) says that one of its top Phase III drug prospects beat out Enbrel in a head-to-head showdown on psoriasis. Investigators say that the anti-IL17A secukinumab (AIN457) nabbed all the primary and secondary endpoints in the study.
Last fall Novartis tapped secukinumab as one of 14 leading drug hopefuls in the late-stage pipeline, an impressive lineup for a pharma giant that spends an industry-leading $9.5 billion a year on R&D. In addition to psoriasis, Novartis plans to release more late-stage results for arthritic conditions next year. And the pharma giant told investors two years ago that secukinumab was a blockbuster contender, with its first regulatory filing slated for this year.
"These results showing that secukinumab (AIN457) is superior to Enbrel, a current standard-of-care therapy, are great news for people living with moderate-to-severe plaque psoriasis," said Tim Wright, the global head of development for Novartis, in a statement. "With 40-50% of people living with moderate-to-severe plaque psoriasis dissatisfied with their current therapies, there is clearly an unmet medical need for new therapies that act faster and longer to relieve pain, itching and other symptoms."
Enbrel (etanercept) brought in $8.37 billion in revenue for Amgen last year, the second-largest bestseller in the business. But there are several competing psoriasis drugs in the clinic. Reuters notes that some analysts expect that new psoriasis treatments could double the market--to more than $7 billion--by 2022, with Eli Lilly ($LLY), Amgen ($AMGN), Celgene ($CELG) and AstraZeneca ($AZN) in the hunt. One of the most closely watched late-stage programs is for brodalumab, another anti-IL17 therapy that Amgen recently partnered with AstraZeneca. And despite Amgen's recent win on the patent front, Cipla has begun rolling out a biosimilar to Enbrel, while Novartis's Sandoz unit has a Phase III biosimilar program under way as well.
Novartis is holding back the data from this new study for a medical conference later in the year. But investigators say the trial was designed to demonstrate efficacy after 12 weeks of treatment, with patients followed up for a full year.
Novartis says this is the first time an anti-IL17A treatment has completed a Phase III trial, noting that the messenger protein appears to play a big role in psoriasis and other autoimmune responses. AIN457 is being studied for psoriasis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis.
- here's the press release
- here's the story from Reuters