What makes this particularly surprising is that in July 2020, mirikizumab hit all primary endpoints against placebo and secondary endpoints against Novartis’ Cosentyx in a Phase III OASIS-2 study of plaque psoriasis.
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Eli Lilly and Company released its first-quarter 2021 financial report, showing an increase in revenue of 16%, driven by 17% volume growth. Even excluding the $810.1 million from its COVID-19 antibodies, revenue growth was 7%.
Key products such as Trulicity, Verzenio, Olumiant, Tyvyt, Emgality, Jardiance, Retevmo, Cyramza and Taltz contributed 8% to revenue growth, making up about 46% of total revenue, or 52% excluding COVID-19 antibody revenue. Operating expenses increased 11%, largely due to greater research-and-development investments, such as $220 million to develop COVID-19 therapies.
One unexpected announcement was the company abandoning plans to submit its mirikizumab to regulators for psoriasis. What makes this particularly surprising is that in July 2020, mirikizumab hit all primary endpoints against placebo and secondary endpoints against Novartis’ Cosentyx in a Phase III OASIS-2 study of plaque psoriasis. At that time, the company indicated it planned to submit for regulatory approval. Mirikizumab is a monoclonal antibody targeting the p19-subunit of IL23. It demonstrated superiority to placebo and non-inferiority to Cosentyx at week 16, and superiority to Cosentyx by week 52.
Lilly indicated it doesn’t plan to submit mirikizumab anywhere, largely because it’s a very crowded market. AbbVie’s anti-IL-23 antibody Skyrizi is out there, as is Johnson & Johnson’s Tremfya and Stelara.
This decision doesn’t mean they’re abandoning the drug altogether but are going to instead focus on ulcerative colitis and Crohn’s disease.
On March 16, Lilly announced that mirikizumab hit the primary and all key secondary endpoints in LUCENT-1, a 12-week Phase III study of the drug for moderate to severe ulcerative colitis. LUCENT-2 is ongoing, studying the drug in patients who completed the 12-week LUCENT-1 induction study.
“There is a continued need for additional treatments that can provide people living with ulcerative colitis relief from their most challenging symptoms,” said William J. Sandborn, Professor of Medicine and chief, Division of Gastroenterology, University of California San Diego. “Results of this study provide further clinical evidence of the potential for mirikizumab to become the first anti-IL-23p19 biologic for the treatment of ulcerative colitis.”
Stelara is already approved for ulcerative colitis, so Lilly believes it can improve on it by targeting only IL-23, compared to Stelara, which targets both IL-12 and IL-23. AbbVie is also studying Skyrizi, which targets IL-23, and J&J is evaluating Tremfya, which also targets IL-23, in Phase II/III ulcerative colitis trials. Their primary completion dates are in 2022.
David A. Ricks, Lilly’s chairman and chief executive officer, stated, “In the first quarter of 2021, Lilly continues to advance our core business and make strategic progress to drive future growth, all while delivering hundreds of thousands of doses of our COVID-19 antibodies to patients and receiving new data for our monoclonal antibody therapies and new authorizations around the world to help fight the COVID-19 pandemic. Our key growth products gained volume and share, helped millions of patients with significant diseases, and represented over half of our core business. We also had a remarkable quarter in R&D beyond our COVID-10 efforts, reading out key late-stage successes with mirikizumab in ulcerative colitis, donanemab in Alzheimer’s, tirzepatide in diabetes, and baricitinib in alopecia areata, while early-stage research continued to deliver and advance exciting clinical-stage molecules across our core therapeutic areas.”
