Innovent bets $250M+ on Union's PDE4 inhibitor ahead of a PhII readout
A year after plucking orismilast from Leo Pharmaceuticals’ pipeline — and without publishing any mid-stage data — Union Therapeutics is already making a pretty penny on the oral PDE4 inhibitor.
Innovent Biologics is shelling out $20 million upfront for development and commercialization rights to Union’s “Phase III-ready” oral formulation of orismilast in China, the companies said early Tuesday morning. Hoping to one-up Amgen’s blockbuster PDE4 inhibitor Otezla in terms of potency, Union’s been pushing the candidate through Phase II trials in skin conditions like psoriasis, atopic dermatitis and hidradenitis suppurativa.
If all goes well in China, the biotech is set to earn another $247 million in milestones, plus tiered royalties on sales. Meanwhile, Innovent says the mid-stage candidate will bolster its autoimmune portfolio.
“I think the Chinese market is undergoing tremendous changes,” Union CEO Kim Kjøller said. “We see big indications like psoriasis and atopic dermatitis really taking off in China.”
Union snagged orismilast from its fellow Danish drugmaker last summer in an up to $200 million deal. PDE4s have long been used to treat skin conditions and other inflammatory conditions. Among the most notable is Otezla, the former Celgene drug that Bristol Myers Squibb sold off to Amgen for $13.4 billion last year after the two companies merged. The drug raked in $2.2 billion last year.
Kjøller says orismilast is designed to be more selective for PDE4 subtypes B and D, which are key for anti-inflammatory properties. And while the CEO hasn’t yet released any Phase II data, he says the drug has shown “good efficacy” and improved potency over other PDE4s.
While offloading the drug last year, Leo said it “demonstrated superior effect over placebo in randomized, double-blinded, placebo-controlled clinical studies.”
That’s about all that we’ll get for now in terms of results. But Kjøller says Phase IIa data in psoriasis and atopic dermatitis are coming “fairly soon,” and Phase IIb trials in those indications are “imminent.” After those trials get underway, it should be another 15 to 18 months until a full readout. There’s also a topical formulation of orismilast in the works for atopic dermatitis, which has completed a Phase IIa study.
While Kjøller has big plans for Union’s future, he also realizes that he’ll need some muscle to be competitive in big indications like psoriasis. After the Phase IIb studies, or perhaps during Phase III, Union will begin looking for another global partner to market orismilast in atopic dermatitis and psoriasis, while handling the more niche indications, like hidradenitis suppurativa, itself.