Roche sells rights to troubled asthma and eczema drug
Once considered a highlight of Roche’s late stage pipeline, the Swiss company said a year ago it was “assessing options” for lebrikizumab after mixed results in two late-stage asthma trials.
Now dermatology specialist Dermira has lifted the lid on the fate of lebrikizumab, which failed to produce results in one of the two trials last year.
California-based Dermira has bought rights to all uses for the IL-13 inhibitor, save interstitial lung diseases such as idiopathic pulmonary fibrosis, in a deal worth up to $1.4 billion.
Lebrikizumab is also being developed as a treatment for atopic dermatitis, also known as eczema, and could be a potential rival to Sanofi/Regeneron’s recently approved Dupixent (dupilimab).
It is this indication of most interest to Dermira, with CEO Tom Wiggans saying that lebrikizumab “could represent a meaningful advancement” in treatment.
Dermira plans to initiate a phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018.
The objective will be to find the optimal dose for a phase 3 trial. The phase 2b trial will evaluate a loading dose and higher dose regimens than were explored in previous eczema studies.
Chief medical officer Eugene Bauer said: “Data from preclinical and clinical studies, including pharmacokinetic and pharmacodynamic results from early clinical experience in atopic dermatitis, are encouraging and suggest higher doses of lebrikizumab could lead to greater efficacy in atopic dermatitis, while potentially offering a less frequent and therefore more convenient dosing regimen relative to existing therapies.”
Dermira will make an initial payment of $80 million to Roche and payments totalling $55 million in 2018.
It will also pay $40 million after beginning the first phase 3 study, up to $210 million upon achievement of regulatory and commercial sales milestones, and $1.025 billion after breaking certain sales targets in certain territories.
Dermira will also have to pay royalties ranging from just under 10% to nearly 20% of net sales.