Earlier this year, Almirall paid Dermira $30 million for the exclusive right to license the latter’s injectable atopic dermatitis treatment in Europe. Now, the Spanish biotech is pulling the trigger on that option, forking over another $50 million to take over a program it reckons could rake in €450 million ($513 million).
The news comes three months after Dermira posted phase 2b data showing that three different dosing regimens of lebrikizumab beat placebo at improving atopic dermatitis symptoms, such as itch and skin inflammation, as measured by the Eczema Area and Severity Index (EASI). Dermira picked up the anti-IL-13 antibody from Roche in 2017 for $80 million upfront.
“We are incredibly pleased to collaborate with Dermira on the lebrikizumab clinical development program and excited by the prospect of delivering what could be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis in Europe, which Almirall believes could achieve potential peak sales of around €450 million,” said Almirall CEO Peter Guenter in a statement.
Under the deal, Dermira stands to net another $30 million when Almirall starts “certain Phase 3 clinical studies” and as much as $85 million when lebrikizumab wins approvals in Europe and hits the market. After that, Almirall could be on the hook for sales milestones and royalties, though the duo kept those figures under wraps.
Lebrikizumab showed a clear advantage over placebo in the phase 2b, but Dermira will need to confirm its findings in a phase 3 study, which it plans to kick off by the end of the year.
It’s hard to compare across trials how Dermira’s prospect stacks up against Sanofi and Regeneron’s Dupixent, thanks to the effects of variables other than the drugs themselves. But keeping that in mind, the phase 2b data suggest lebrikizumab could pose a challenge to Dupixent: When given at 250 mg doses every two weeks, lebrikizumab performed numerically better on EASI than Dupixent did in the trials that supported its approval.
Lebrikizumab could one-up Dupixent if it can offer a more attractive dosing schedule. In the phase 2b, Dermira tested a once-monthly regimen that worked, but did not have a clear efficacy edge over twice-monthly Dupixent. The EASI scores for once-monthly lebrikizumab and twice-monthly Dupixent are comparable, but a smaller percentage of people taking Dermira’s regimen experienced a clearing or near-clearing of skin lesions.
Dermira’s drug isn’t the only one chasing Dupixent—last month, a JAK inhibitor from Pfizer hit all of its primary and key secondary endpoints in a phase 3 study testing it in atopic dermatitis. Patients on both doses of abrocitinib achieved clear or almost clear skin versus placebo after 12 weeks, with a higher percentage of patients seeing 75% or greater improvement in their eczema from baseline.
Patients started seeing improvements two to four weeks after starting abrocitinib. Although the drug must be taken daily, unlike twice-monthly Dupixent, it may still be more attractive to patients than either Dupixent or lebrikizumab, which are both injected.
“Dupixent is an effective drug for AD, but it is an injection, and patients usually prefer orals,” Cantor Fitzgerald analyst Louise Chen wrote in a Wednesday note to investors in May.