- Swiss pharma giant Roche will offload an experimental treatment for atopic dermatitis, selling worldwide rights to its IL-13 blocker lebrikizumab to Dermira, Inc. for $80 million upfront in a deal potentially worth $1.4 billion.
- Per the deal, Dermira will owe Roche another $55 million next year and $40 million after initiation of the California dermatology company's first Phase 3 trial of the drug. Much of the deal's total value, though, only comes due upon meeting unspecified sales thresholds down the road.
- Lebrikizumab has had mixed results to date. Roche last year halted development of the drug in severe asthma following a Phase 3 failure and disappointing, albeit technically successful, result from another Phase 3 study. Development in chronic obstructive pulmonary disease was also dropped earlier this year.
One pharma's unwanted candidate is another biotech's blockbuster to be — or so Dermira hopes.
The agreement with Roche will give Dermira exclusive rights to lebrikizumab in atopic dermatitis and all other indications except for interstitial lung diseases such as idiopathic pulmonary fibrosis, which Roche will retain.
Atopic dermatitis is seen as a relatively untapped market compared to the saturated field of therapeutics for other inflammatory skin conditions like psoriasis. Hoping to take advantage of that potential, French drugmaker Sanofi S.A. and its partner Regeneron Pharmaceuticals, Inc. recently won U.S. approval and subsequently launched Dupixent (dupilumab), also an IL-13 inhibitor.
While competition from Dupixent and other candidates currently in testing elsewhere in the industry would be fierce, Dermira is touting lebrikizumab as a potential best-in-class IL-13 blocker.
"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," said Dermira Chief Medical Officer Eugene Bauer, explaining the rationale for picking up lebrikizumab.
Dermira plans to launch a Phase 2b dose-ranging study to test lebrikizumab in atopic dermatitis sometime in the first quarter of next year.
Including the upfront and 2018 fees paid to Roche, Dermira estimates it will cost about $200 million to obtain topline results from that study. That shouldn't put too much of a financial strain on the biotech, which estimated at the end of June it had roughly $696 million in cash, equivalents and investments on hand.
Yet, with lackluster results from the drug in asthma and high-powered pharma competitors moving into atopic dermatitis, that may be a steep price to pay for advancing the drug.