Eli Lilly and Co. said Thursday it will submit its experimental drug for psoriasis for regulatory approval after the medicine in two large-scale trials helped six times as many patients completely clear up their skin irritations as an existing treatment.
Lilly’s drug, ixekizumab, is in a race with two others to be the first in a new class of psoriasis treatments to reach the market. Lilly expects to submit the drug to regulators—most likely in the United States, Europe and Japan—in the first half of 2015.
It often takes six months to 12 months for the U.S. Food and Drug Administration to review a drug and, upon approval, for a company to bring it market.
If approved, the psoriasis drug would be a major milestone for Indianapolis-based Lilly, which has not launched a drug produced by its own labs since 2004. Ixekizumab also would be the first sophisticated biotech drug, known as a monoclonal antibody, that Lilly has launched from its own labs.
It also would cap a decade-long effort to re-enter the biotech and autoimmune spaces that Lilly helped pioneer in the 1980s but then abandoned in the 1990s—just before biotech and autoimmune drugs caught fire in the marketplace.
“From a business perspective, it’s significant,” said Dave Ricks, president of Lilly’s Bio-Medicines division, noting that Lilly is trying to launch new products to replace the sales lost as its bestselling products—the antipsychotic Zyprexa and the antidepressant Cymablta—have faced competition from cheaper generic versions. “It’s a good day for Lilly,” he said.
But the commercial prospects for ixekizumab are uncertain. Before Thursday’s announcements, Wall Street analysts expected the drug to fall short of $1 billion in annual sales by 2020.
Enbrel—the drug against which Lilly compared ixekizumab in its clinical trials—sells for about $30,000 per patient per year. The drug, which is approved to treat numerous autoimmune diseases including psoriasis, had nearly $8 billion in sales last year, according to market research firm IMS Health.
Lilly’s drug would compete for patients against Enbrel and, most likely, against the two other new drugs seeking regulatory approval for psoriasis.
Switzerland-based Novartis AG already has submitted its drug for psoriasis to the FDA, and expects a decision as early as year’s end.
California-based Amgen Inc., the maker of Enbrel, has partnered with United Kingdom-based Astra Zeneca plc on a new drug for psoriasis, but they have yet to complete all of their late-stage testing.
Ricks said he considers Lilly in second place in the race to launch the first of the new generation of psoriasis drugs. But he also thinks the drug with the best impact on patients will prove to be the ultimate winner in the marketplace.
“With the results so far, we believe have some excellent evidence to support the launch of ixekizumab,” Ricks said.
Among patients taking ixekizumab, 31 percent to 41 percent—depending on the dose they took—saw their skin plaques completely disappear in 12 weeks. By contrast, among patients in the study taking Enbrel, just 5 percent to 7 percent saw complete clearance within 12 weeks.
At the start of Lilly’s studies patients had moderate to severe psoriasis, which means 20 percent of their skin, on average, was covered with the red plaques caused by psoriasis.
In a smaller study, Amgen and AstraZeneca’s drug achieved complete clearance in 23 percent to 42 percent of patients.
Novartis did not publicly report complete clearance data for its psoriasis drug, but said more than 54 percent of patients achieved 90 percent clearance or better after 12 weeks, compared with 21 percent of patients on Enbrel.
Ricks said total clearance will be the most importance measure for patients, and the best way to keep them taking the drugs for the long term.
“We will be talking about complete clearance,” Ricks said. “Nobody wants to be a little bit sick.”
Regulators will likely focus most on how many patients saw at least 75 percent of their red plaques disappear. In Lilly’s study, 78 percent to 90 percent of the patients achieved that result after 12 weeks.
By contrast, the Amgen/AstraZeneca drug cleared up three-quarters of the psoriasis plaques in 60 percent to 83 percent of patients.
After 12 weeks, Novartis’ drug cleared up three-quarters of the plaques in 67 percent to 82 percent of patients.
Enbrel has been shown to clear away three-quarters of psoriases plaques in 40 percent to 60 percent of patients after 12 weeks.