Dermira said today it has agreed to obtain exclusive, worldwide rights from Roche and its Genentech subsidiary to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin-13 (IL-13), for most indications, in a deal that could generate up to $1.4 billion for the pharma giant.
Under the companies’ licensing agreement, Dermira will gain rights to lebrikizumab in atopic dermatitis and all other indications except interstitial lung diseases, such as idiopathic pulmonary fibrosis—indications to which Roche will retain rights.
Roche tried and failed last year to advance lebrikizumab in asthma, acknowledging disappointing results from two Phase III trials in February 2016. The LAVOLTA II trial missed its primary endpoint by showing rates of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils that were not statistically significant.
However, the LAVOLTA I trial met its primary endpoint, showing a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, as well as significant improvement in lung function as measured by forced expiratory volume in one second (FEV1)—though observed effects were less than seen in Phase II studies.
Today, Dermira said it planned to launch a Phase IIb dose-ranging study assessing lebrikizumab in adults with moderate-to-severe atopic dermatitis in the first quarter of 2018. The goal of the study will be to optimize the dose of lebrikizumab for an eventual Phase III clinical program.
Preliminary design elements of the Phase IIb dose-ranging study include evaluating a loading dose and higher dose regimens of lebrikizumab than were explored in previous atopic dermatitis studies, according to Dermira.
“The addition of this program to our development portfolio represents an important step toward our goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions,” Dermira chairman and CEO Tom Wiggans said in a statement.
Promising Preclinical, Early Clinical Results
Dermira CMO Eugene Bauer, M.D., added that lebrikizumab has generated promising preclinical and early clinical data that have suggested that 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 has agreed to pay Roche an initial $80 million this year and $55 million in 2018—as well as payments tied to achieving milestones.
The milestone payments include $40 million upon the initiation of Dermira’s first Phase III clinical study, up to $210 million upon achieving regulatory and first commercial sale milestones in certain territories, and up to $1.025 billion upon achieving net sales thresholds for lebrikizumab in indications other than interstitial lung disease.
Under their collaboration, Roche retains exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.
Dermira added that it also agreed to pay Roche royalties totaling percentages of net sales ranging from the high single-digits to the high teens.
The deal is expected to close in the third quarter, subject to expiration or termination of the waiting period under the Hart–Scott–Rodino Antitrust Improvements Act, as amended.