Amgen is handing back the rights of its successful in-licensed atopic dermatitis (AD) asset, rocatinlimab, to Kyowa Kirin.
In a statement to Pharmaceutical Technology, an Amgen spokesperson noted that this move was part of its “ongoing portfolio prioritisation process”, which will see the company transfer responsibility for the rocatinlimab programme back to its original developer.
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As Amgen relinquishes its stake in the anti-OX40 monoclonal antibody (mAb), Kyowa will now take full responsibility for the drug’s further development, as well as future regulatory submissions and commercialisation efforts involving the OX40 receptor agonist. The Tokyo-based pharma plans to submit rocatinlimab to regulators for AD in H1 2026.
If rocatinlimab gets the regulatory go-ahead, Kyowa plans to “commercialise the drug through a flexible, market-by-market approach, starting in the US”, the company’s president and COO, Abdul Mullick tells Pharmaceutical Technology.
Mullick said: “Kyowa Kirin is confident in the potential of rocatinlimab to address critical unmet needs for patients with moderate-to-severe AD, who are looking for new long-lasting options that may address the chronic nature of unpredictable flares. Rocatinlimab’s science and its highly differentiated mechanism of action targeting the OX40 receptor make it a potentially unique treatment option.”
A patient-based forecast from GlobalData estimates that rocatinlimab will generate 2033 global sales of $1.7bn in AD.
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By GlobalDataThe OX40 ligand’s role in AD
Once touted as one of the most promising new targets in AD, analyst excitement around the OX40 drug class has taken a hit as trial data have failed to meet expectations. This comes as recent late-stage efficacy and safety readouts for both rocatinlimab and Sanofi’s rival OX40 candidate, amlitelimab, garnered lukewarm responses.
During the Phase III ROCKET-IGNITE, ROCKET-HORIZON and ASCEND trials of rocatinlimab, the drug met all its co-primary and secondary endpoints, but efficacy results generally fell short of analyst expectations.
It was a similar outcome for amlitelimab, which did not live up to the legacy of Sanofi and Regeneron’s best-selling AD drug, Dupixent (dupilumab), leading GlobalData analysts to theorise that the drug will see most uptake in the second- or third-line setting.
In the Phase II ATLANTIS trial (NCT05769777) in AD, treatment with amlitelimab also triggered a cutaneous case of Kaposi’s sarcoma – a rare vascular cancer linked to OX40 deficiency – in a patient with known risk factors. In a research note, William Blair analyst Matt Phipps noted that this finding “could be a real safety risk for the OX40 class”.
However, Mullick believes that the mechanistic differences between OX40 ligand (amlitelimab) and OX40 receptors’ (rocatinlimab)-targeting approaches mean that “findings for one should not predict outcomes for the other”.
Unmet needs in AD
In recent years, biologics have triggered a fundamental shift in the AD treatment landscape, with therapies like Dupixent offering patients significant symptomatic relief while showing some disease-modifying potential.
Despite these advancements, Mullick cautions that a large number of patients do not achieve optimal treatment targets. “More than 50% of patients receiving systemics discontinue within the first year, highlighting the remaining need for options that provide more long-term control of the disease,” he said.
According to Mullick, rocatinlimab’s differentiated mechanism of action makes it “unique”, with its potential as a treatment option expanding across a range of clinical scenarios.
A recent report from GlobalData, parent company of Pharmaceutical Technology, forecasts that the AD market will be worth $22.4bn across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) by 2033.
