In the crowded race to launch new therapies for psoriasis, India’s largest drugmaker Sun Pharma hustled to the finish line Thursday with FDA approval of tildrakizumab. Unfortunately for Sun, several other drugmakers were already there waiting.
The company’s biologic, which is now branded as Ilumya, was first in-licensed from Merck back in 2014 for $80 million. The med, delivered through subcutaneous injection, was already in Phase III trials at the time of the deal, and Merck handed all regulatory and launch responsibilities over to Sun.
Ilumya is an IL-23 drug like J&J’s Tremfya (guselkumab), only… well, not as good. Last year J&J launched Tremfya for the same indication – moderate to severe plaque psoriasis – and it had a better safety profile than existing brands.
But Sun isn’t only going against J&J. The company is rather late to reach the market, with competition coming from J&J’s Stelara, Novartis’ Consentyx, Valeant’s Siliq, and Eli Lilly’s Taltz. Oh, and then there’s AbbVie and Boehringer Ingelheim, which are developing rival drug risankizumab. It has promising clinical results so far.
Even with all those rivals, analysts expect Ilumya can reach $350 million in peak sales in three to four years. Setting the drug’s price competitively will be critical for Sun to elbow its way into the market.
The FDA OK for the drug was based on two Phase III trials dubbed Resurface 1 and 2, in which 926 adult patients were treated with Ilumya or placebo. Results were published in The Lancet in July 2017, and presented at last year’s EADV, which Endpoints covered at the time. Both studies met their primary endpoints but failed to beat out J&J’s results for Tremfya.
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