Following fast on the heels of a rival development team at Novartis ($NVS), Eli Lilly ($LLY) has posted a superior therapeutic profile for its experimental late-stage psoriasis drug ixekizumab compared to Pfizer's ($PFE) and Amgen's ($AMGN) Enbrel in a head-to-head study. And Lilly says the results from a set of Phase III studies are good enough to back a regulatory filing in the first half of 2015 for its IL-17A therapy as it races to gain some new approvals following a punishing onslaught of generic competition to its top drug franchises.
Here are the relevant numbers reported by Lilly: "For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score (PASI 75) at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5 to 7 percent of patients treated with etanercept (Enbrel) in the UNCOVER-2 and 3 studies achieved PASI 100."
This is one of the most competitive fields in late-stage research, though, and Lilly won't be up against Enbrel when it hits the market, provided it pulls in an approval.
Just days ago Novartis pumped out more positive Phase III data for its IL-17 treatment secukinumab, demonstrating that over half of the patients in the experimental drug arm achieved a skin clearance rate of 90% or more, with just 20.7% of the patients in the Enbrel arm doing the same. Amgen and AstraZeneca, meanwhile, have been hurrying along brodalumab. Celgene recently won an approval for Otezla (the oral apremalist) for psoriatic arthritis and filed its application on psoriasis last fall. Merck's ($MRK) MK-3222 is also coming along. And cheaper biosimilars of Enbrel have been pushed along by Cipla and Novartis and others.
Coming up from behind is Johnson & Johnson's guselkumab, which is moving into Phase III this year. The drug targets IL23p19 and is partnered with MorphoSys AG. The drug is touted as a top contender in J&J's pipeline, with a prospective approval coming in the 2015-2017 time frame.
Lilly, meanwhile, is happy to be among the leaders in the late-stage rush to the FDA.
"These data appear to confirm our hypothesis--that IL-17A is a major driver of excess keratinocyte (skin cell) proliferation and activation in psoriasis," said Tom Bumol, senior vice president of biotech discovery research, Lilly Research Laboratories.
- here's the release