Dive Brief:

• Amgen is backing out of a deal for an eczema drug it spent considerable resources developing, handing rights back to Kyowa Kirin for a medication called rocatinlimab that completed its first Phase 3 studies more than a year ago
• Amgen’s decision was based on a “strategic portfolio prioritization,” the Japan-based drugmaker said Friday, adding that it plans to seek regulatory approvals in the first six months of the year. Kyowa Kirin is “confident in the potential of rocatinlimab,” said Abdul Mullick, the company’s president, in a statement.
• While the two rocatinlimab trials in eczema achieved their primary goals, investors and Wall Street analysts have viewed them as disappointing compared to leading treatments like Regeneron and Sanofi’s Dupixent. Sanofi, though, is still planning regulatory submissions for a drug in the same class despite results that fell short of expectations.

Dive Insight:

Amgen licensed rocatinlimab from Kyowa Kirin in 2021, paying $400 million upfront and promising up to $850 million more for most rights. The allure was a drug targeting an immune-regulating protein called OX40, which offered a new way of treating many autoimmune conditions.
  
Amgen and Kyowa Kirin have since brought that drug into a sprawling late-stage program involving several Phase 3 trials in eczema. Phase 3 results revealed last year and later published in The Lancet showed rocatinlimab outperformed a placebo in reducing the number and size of skin lesions, and drug recipients reached clear or nearly clear skin.

But rocatinlimab also didn’t look better than Dupixent. Moreover, the trials revealed that one in eight enrollees who got rocatinlimab experienced fever — and 6% reported chills — which were considered injection-related reactions.

Those “relatively high rates” were part of a side effect profile that “was going to be commercial challenge in treating chronic conditions like atopic dermatitis, and also potentially limiting dosing intensity and therefore efficacy,” wrote William Blair analyst Matt Phipps in a Friday note to clients.

In a separate note, Leerink Partners analyst David Risinger added that Amgen hadn’t outlined plans to seek approvals in the 16 months since it announced the first Phase 3 results, nor did it mention the drug at a recent investor presentation. Risinger had forecast $812 million in sales by 2032, a mere fraction of Dupixent’s 15.7 billion euros, or $18.7 billion, in 2025 sales.

“We are not surprised” that Amgen returned the drug to Kyowa Kirin, he wrote. 

Risinger also wrote that a different OX40 inhibitor developed by ImageneBio might prove safer because it doesn’t deplete T cells, as rocatinlimab does.

Kyowa Kirin said it plans to submit rocatinlimab first to the FDA and then to drug regulators in Japan.