Sun Pharmaceutical Industries has taken the lead in a fiercely contested race to market with Johnson & Johnson for a new class of psoriasis drug, but first-to-market status may not be enough to beat its putative rival.
The Indian drugmaker now has positive results in hand from two Phase III trials of tildrakizumab, an interleukin-23 (IL-23) inhibitor that it licensed from Merck & Co. in 2014 in a deal worth $80 million upfront.
Armed with two positive pivotal studies, Sun Pharma says it is now gearing up to file its first marketing applications for tildrakizumab in the U.S. and Europe. That would put it ahead of J&J's pharma division Janssen, which has just reported positive results from the first of three planned Phase III trials of guselkumab.
Sun's med did beat placebo and Amgen's TNF inhibitor Enbrel--an older biologic treatment for the disease--in two separate trials, measured by its ability to clear psoriasis lesions. The studies were presented as the European Academy of Dermatology and Venereology (EADV) congress in Vienna came to a close this weekend.
But Janssen's drug also did better than a TNF inhibitor--AbbVie's Humira--in the VOYAGE 1 trial presented at EADV. And its margins against placebo and against Humira were both larger than Sun's superiority over placebo and Enbrel. Though it's tough to compare data from trials that aren't head-to-head contests, payers and doctors do keep such data in mind when making coverage and treatment decisions.
Still, Sun obviously will have its own argument for tildrakizumab, and first-mover advantage would be a boost. The new trial results "further validate the central role of IL-23 as a key regulatory cytokine and treatment target in psoriasis," said Sun Pharma's head of biologics and dermatology Jesper Jensen.
While Sun Pharma and Janssen are currently in leading the IL-23 race with Phase III data in hand, there are a couple of other candidates nipping at their heels.
AstraZeneca and Amgen have been developing their own IL-23 inhibitor called MEDI2070 in Phase II testing, but today decided to license it to Allergan. That deal included an upfront fee of $250 million and milestones of $1.27 billion, which gives an indication of the potential attached to the drug. Meanwhile, Boehringer Ingelheim and partner AbbVie are in the process of preparing for registration trials for their candidate, codenamed BI 655066.
All four drugs are hoping to displace Janssen's older IL-12 and IL-23 inhibitor Stelara (ustekinumab), which has been on the market for psoriasis and other inflammatory diseases since 2009 and achieved almost $2.5 billion in sales last year. The idea is that by selectively targeting IL-23 only, the newer antibodies will maintain or improve on the efficacy of Stelara, but be less prone to side effects.
Boehringer already has mid-stage results in hand showing that BI 655066 worked better than Stelara in psoriasis, clearing skin lesions in a higher proportion of patients.
But tildrakizumab, guselkumab and their tagalongs could have their work cut out claiming a slice of what is an increasingly crowded market for products that promise a step-up in efficacy over the TNF inhibitors.
Tildrakizumab will also have to contend with new IL-17 inhibitors, currently headed by Novartis' Cosentyx (secukinumab) which has been making impressive headway in the U.S. since its launch last year. Two other new IL-17 inhibitors--Eli Lilly's Taltz (ixekizumab) and Kyowa Hakko's Lumicef (brodalumab)--have also been launched and will only add to the intensity of the competition.
- read Sun Pharma's press release
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