AbbVie's IL-23 Inhibitor, Skyrizi, Approved in Europe for the Treatment of Plaque Psoriasis
Entry into the European Psoriasis Market and AbbVie's Commercialization Strategy
The European Medicines Agency (EMA) approved AbbVie's (ticker: ABBV) interleukin-23 (IL-23) inhibitor, Skyrizi (risankizumab), for the treatment of moderate-to-severe plaque psoriasis on April 26, 2019. This approval, which came shortly before the patent expiration of AbbVie's global blockbuster drug, Humira, marked a pivotal turning point in AbbVie's transition to a next-generation portfolio of autoimmune disease treatments. By providing patients with plaque psoriasis in Europe with a highly effective targeted treatment option, Skyrizi is expected to significantly improve their quality of life. In particular, Skyrizi boasts the convenience of a once-every-four-month dosing schedule, giving it a strong competitive edge over existing treatments.
Excellent Skin Improvement Effects Proven in Phase 3 Clinical Trials
The European approval of Skyrizi was based on the excellent data from the global Phase 3 trials, UltIMMa-1 and UltIMMa-2. In the clinical trials, 75% of patients in the Skyrizi group achieved a PASI 90 response rate, indicating a 90% or greater improvement in skin lesions at week 16, demonstrating overwhelming superiority compared to the placebo group (less than 5%) and the active control group, Stelara (ustekinumab, PASI 90 of 42-48%). At week 52, the PASI 90 response rate was 81-82%, and PASI 100, indicating complete skin clearance, was achieved in up to 60% of patients. This long-term and excellent efficacy data provides clinicians with the confidence they need to make prescribing decisions and is a powerful tool for accelerating regulatory approvals and reimbursement in Europe.
Joint Development Partnership and Deal Terms with Boehringer Ingelheim
Skyrizi was originally developed by Boehringer Ingelheim, but in March 2016, AbbVie entered into a global joint development and commercialization partnership, marking a turning point. Under the terms of the agreement, AbbVie paid Boehringer Ingelheim an upfront payment of $595 million, with no royalty obligations, and agreed to provide future development and regulatory milestone payments and royalties based on sales. Because AbbVie has exclusive global commercialization rights, it will be the primary beneficiary of the sales generated by this European approval. This is considered a prime example of a win-win business model between a major pharmaceutical company and an innovative biotech company.
Fierce Competition and Prospects in the IL-23 Inhibitor Market
At the time, the global psoriasis treatment market was valued at approximately $14.5 billion, and several competing drugs targeting IL-23, such as Janssen's Tremfya (guselkumab) and Sun Pharma's Ilumya (tildrakizumab), had already been launched. Despite being a late entrant, Skyrizi quickly gained market share due to its convenient once-every-four-month dosing schedule and the unique skin-clearing effects demonstrated in clinical trials. Industry analysts predicted that Skyrizi would become a key growth driver for AbbVie, helping to offset the revenue loss from the patent expiration of Humira. Indeed, this approval marked a turning point in the European market, reshaping the competitive landscape and ushering in a new generation of standard-of-care treatments.
This European approval of Skyrizi is a key milestone for AbbVie to establish itself as a leading player in the global psoriasis market, which is valued at $14.5 billion annually. In particular, the superior PASI 90/100 response rates demonstrated in Phase 3 clinical trials compared to existing IL-23 inhibitor competitors, such as Janssen's Tremfya, and the convenient once-every-four-month dosing schedule, are short-term factors that will maximize prescription uptake and market penetration. In the medium to long term, it is expected to offset the revenue loss from the patent expiration of Humira and expand its annual revenue potential to billions of dollars through additional indications, such as Crohn's disease and ulcerative colitis, and regulatory approvals. The $595 million upfront payment made to Boehringer Ingelheim under the joint development partnership serves as a successful benchmark for risk-sharing drug development and provides valuable insights for researchers and licensing professionals. In conclusion, the European commercial approval of this drug will enhance AbbVie's medium- to long-term financial visibility and serve as a strong catalyst for re-evaluating the value of its global immunology pipeline.
Source: EMA (ema)