For Abbvie, proving that its psoriasis project risankizumab is better than the last generation of marketed agents is only half the battle. The company will also have to elbow its way into a sector crowded with new and old biologicals.
The IL-23 inhibitor looks like it will have to fight for market share as it will trail classmates Johnson & Johnson and Morphosys’s Tremfya and Merck & Co and Almirall’s tildrakizumab to the market. With Celgene yesterday revealing weakening sales growth for its four-year-old product, Otezla, the outlook for new psoriasis entrants might be dimming.
That said, there should be little doubt that risankizumab is a clinical success. Phase III data released yesterday show that it outperformed Abbvie’s own Humira, a TNF-blocking antibody, and Johnson & Johnson’s Stelara, an IL-12 and 23 blocking antibody, in terms of clearing patients’ skin of plaque.
A co-primary endpoint of the three phase III trials was a 90% improvement in the psoriasis area and severity index (PASI90) after 16 weeks. This was achieved by 75% of risankizumab patients in two of the studies, and 72% in a third. This puts Abbvie’s project on an even footing with Tremfya, which had a PASI90 result in 70-73% of the patients in its phase III trials, although the usual caution about across-trial comparisons should apply.
Differentiating itself from Tremfya could be hard for risankizumab and could come down to the agents’ side-effect profiles. Fuller safety data will likely be revealed at a medical meeting or in a peer-reviewed journal.
Will it sell?
Tremfya has been approved by the US FDA, and the Merck IL-23 tildrakizumab is due a decision early next year. Risankizumab, meanwhile, is not expected to launch until 2019, putting it on the back foot in terms of marketing; Tremfya also demonstrated superiority to Humira in its pivotal programme and has taken on the new entrant Cosentyx in the Eclipse trial.
|Top 10 psoriasis products by 2022|
|Global indication sales ($)|
|Product||Pharma class||Company||2016||2018e||2020e||2022e||Indication status|
|Stelara||Anti-IL-12 & IL-23 MAb||Johnson & Johnson||3,109||3,867||4,431||4,723||Marketed|
|Otezla||PDE 4 inhibitor||Celgene||877||1,766||2,512||3,184||Marketed|
|Tremfya||Anti-IL-23 MAb||Johnson & Johnson||-||378||908||1,532||Approved|
|Risankizumab||Anti-IL-23 MAb||Abbvie||-||-||117||397||Phase III|
|Remicade||Anti-TNFa MAb||Johnson & Johnson||1,775||1,207||599||276||Marketed|
The new IL-23s have to contend with entry of new biologicals in other classes, such as the IL-17s Cosentyx and Taltz, but also with patent expiries of psoriasis mainstays like Enbrel and Remicade, along with Humira in 2023.
In the IL-23 class only Tremfya is forecast to become a blockbuster by 2022, and Celgene’s Otezla outlook could have analysts taking a closer look at their assumptions across drug classes (Celgene slide piles pressure on Revlimid, October 26, 2017).
Abbvie needs to see strong sales growth sustained in the category. In addition to justifying the $595m it paid Boehringer Ingelheim to license in risankizumab, Humira’s eventual expiry puts at risk nearly $20bn in annual revenue. It will take a lot of successful new drugs to replace that.