LEO bulks up with deal for Boehringer skin drug

Danish dermatology specialist LEO Pharma has licensed a medicine for a rare form of psoriasis from Boehringer Ingelheim, plugging a gap in its near-term product portfolio after a late-stage pipeline failure last year.

LEO is paying privately-held German group Boehringer €90 million (around $105 million) upfront for rights to Spevigo (spesolimab), an IL-36 inhibitor which was approved in the US in 2022 and in Europe last year to prevent the eruptions of painful blisters, known as flares, in patients with generalised pustular psoriasis (GPP). The deal also includes unspecified milestone payments.

Spevigo is the first approved therapy for GPP, and the first drug in the IL-36 inhibitor class to make it through development and onto the market.

Currently, ciclosporin, acitretin, and other drugs that inhibit different cytokines and are used for other forms of psoriasis are used off-label to try to support patients experiencing a flare, but there is limited evidence for their efficacy.

GPP is very rare, estimated to affect between 1.76 to 124 people per million, but flares can be serious enough to hospitalise patients with complications like heart failure, renal failure, and sepsis. Patients living with the skin disorder often experience severe anxiety and diminished quality of life due to its unpredictability.

LEO is claiming global commercial rights to Spevigo for GPP, but will also collaborate with Boehringer on potential follow-up IL-36 mediated skin diseases, such as palmoplantar pustulosis and hidradenitis suppurativa. To date, the drug has been launched in more than 40 countries, including the US, Japan, China, and most European countries.

Boehringer said handing the new product over to LEO will "accelerate and broaden access" for patients around the world, drawing on the Danish company's "six decades of dermatology expertise." The deal is due to close before the end of this year, subject to the usual antitrust reviews.

For LEO, taking control of Spevigo also helps to offset the disappointment last year of a failed phase 3 trial of a drug for another rare and potentially life-threatening skin disorder, congenital ichthyosis, which was the main asset in its acquisition of Timber Pharma just a few months earlier. The drug (TMB-001) – an ointment formulation of well-established dermatology therapy isotretinoin – no longer appears in its R&D pipeline.

Competition could be on the way for Spevigo, in the form of Vanda Pharma/AnaptysBio's rival IL-36 inhibitor imsidolimab, which is due to be filed for approval in the US before the end of this year. AnaptysBio licensed imsidolimab to Vanda earlier this year for $15 million upfront and $35 million in milestones.