Lebrikizumab is a monoclonal antibody designed to treat atopic dermatitis.
Biopharmaceutical company Dermira has entered into a licensing agreement with F. Hoffmann-L Roche and Genentech to obtain exclusive, worldwide rights for the development and commercialization of lebrikizumab.
Lebrikizumab is a monoclonal antibody designed to specifically target interleukin 13 (IL-13) for patients with moderate-to-severe atopic dermatitis, according to a press release.
Under the agreement, Dermira will make an initial payment of $80 million to Roche and payments totaling $55 million in 2018. Furthermore, the company is obligated to make additional payments upon achieving certain milestones.
These milestones comprise $40 million upon the initiation of Dermira’s first phase 3 clinical trial, up to $210 million upon the achievement of regulatory and first commercial sale milestones in certain territories, and up to $1.025 billion based on the achievement of certain thresholds for lebrikizumab’s net sales for indications other than interstitial lung disease.
Dermira will make royalty payments representing percentages of net sales ranging from high single-digits to high teens upon potential regulatory approval.
“Atopic dermatitis is one of the most common skin diseases in the world, affecting millions of adults and children, and moderate-to-severe forms of this condition present a tremendous burden for patients,” Tom Wiggans, chairman and CEO of Dermira said in the release. “We believe atopic dermatitis is one of the greatest unmet needs in dermatology, and lebrikizumab, if successfully development and approved, could represent a meaningful advancement in the treatment of this disease.
“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.”
Upon the closing of the deal, Dermira expects to record a charge related to the acquisition of in-process research and development for $135 million, consisting of the $80 million initial payment and $55 million due in 2018, according to the release. The transaction is expected to close in the third quarter of 2017.
Additionally, the company estimates to incur up to $10 million in operating expenses in 2017 regarding costs related to transferring the lebrikizumab program to Dermira and prepping for the initiation of the phase 2b dose-ranging study, according to the release.
The company projects spending approximately $200 million to obtain topline results for the phase 2b study—–this includes the payments to Roche and program-related costs. The phase 2b dose-ranging study will assess lebrikizumab in adult patients with moderate-to-severe atopic dermatitis. Dermira plans to initiate the study in the first quarter of 2018.
Preliminary design elements of the phase 2b dose-ranging study include evaluating a loading dose and higher dose regimens of lebrikizumab than those explored in prior atopic dermatitis studies. The primary objective is to optimize the dose of lebrikizumab for the design of a phase 3 program.
“Lebrikizumab is a potent and specific inhibitor of IL-13 with a differentiated mechanism of action and attractive pharmacokinetic properties,” Eugene Bauer, MD, chief medical officer of Dermira said in the release. “Data from preclinical and clinical studies, including pharmacokinetic and pharmacodynamics 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. If successfully developed, we believe that lebrikizumab could be a best-in-class IL-13 inhibitor and could have a best-in-disease profile.”
Atopic dermatitis is the most common form of eczema, characterized by patches of dry, red skin that may have scales and/or crust. It affects at least 28 million individuals of all ages in the United States, according to the American Academy of Dermatology.