Eying eczema, Amgen pays $400M to co-develop Phase 3-ready Kyowa Kirin drug

Amgen

Amgen is vying to bolster its immunology drug portfolio and it is paying $400 million to do it. The sum gives it a share of an antibody from Kyowa Kirin that offers a new way of treating atopic dermatitis and potentially other inflammatory disorders. But a blockbuster Sanofi and Regeneron Pharmaceuticals drug already treats this condition and others are in the chase for this market, so the partners will need to post strong results in pivotal studies to show they can compete.

The deal announced Tuesday covers Kyowa Kirin’s experimental antibody drug, KHK4083. According to terms of the agreement, Amgen will lead in the development, manufacturing, and commercialization of the drug globally, except for Japan, where Kyowa Kirin keeps the antbody’s rights. In the U.S., the two partners will co-promote the drug. Kyowa Kirin has the right to opt-in to co-promote the drug in certain markets, including Europe and Asia.

The $400 million that Thousand Oaks, California-based Amgen agreed to fork over is an upfront payment. If the drug achieves development and regulatory milestones, Kyowa Kirin could earn up to $850 million more, plus royalties from sales.

Atopic dermatitis is the most common form of eczema, an inflammatory condition that leads to dry and itchy skin prone to rashes and redness. The condition is chronic and has no cure. Treatment options include biologic drugs that block inflammatory responses that drive the disorder.

Kyowa Kirin’s KHK4083 targets OX40, a co-stimulatory receptor expressed on activated T cells. This receptor plays a role in maintaining T cell proliferation and survival. The Kyowa Kirin drug blocks signaling of OX40, which is intended to suppress the inflammatory responses associated with atopic dermatitis.

Kyowa Kirin advanced KHK4083 to a placebo-controlled Phase 2 study enrolling 274 patients with moderate-to-severe atopic dermatitis that was not adequately controlled with topical medications. Those patients were randomly assigned to receive one of three different doses of the subcutaneously injected drug given in two different dosing regimens, or a placebo.

In February, Kyowa Kirin announced that the drug met the Phase 2 test’s main goal of showing improvement according to an eczema severity assessment. The company said all groups given the experimental drug posted statistically significant improvement on the eczema assessment compared to the placebo group at 16 weeks. The company added that further improvement was observed after week 16. Detailed results about how the drug performed in each of the test groups were not disclosed. No deaths were reported in the study and side effects observed included fever, colds, a worsening of atopic dermatitis, and chills.

Dupilumab, a drug from partners Sanofi and Regeneron that is marketed as Dupixent, is an antibody that blocks the IL-3 and IL-4 signaling pathways, both of which are drivers of the type of inflammation that develops in atopic dermatitis. These pathways are also associated with immunological and inflammatory disorders, including asthma and chronic rhinosinusitis with nasal polyps, two indications for which the drug has received approvals. In 2020, Sanofi reported that Dupixent accounted for €3.5 billion in sales, a more than 70% increase over the prior year.

Eli Lilly is pursuing the atopic dermatitis market with lebrikizumab, an antibody that it added to its portfolio last year via the $1.1 billion acquisition of Dermira. The drug, which is designed to bind to and block IL-13, is currently in Phase 3 testing. LEO Pharma has filed for FDA approval of its antibody, tralokinumab, for treating moderate-to-severe atopic dermatitis. But last month, the company received a rejection letter asking for more information about the device component of the combination product. Meanwhile, AbbVie is trying to add atopic dermatitis to the list of indications for its approved rheumatoid arthritis drug, Rinvoq. In April, AbbVie said that the FDA extended its review of the drug, a JAK inhibitor, to early in the third quarter of this year.

In an investor presentation, Amgen said that the Kyowa Kirin drug fits the pharma giant’s experience in inflammatory disease and its portfolio of drugs that includes Enbrel, Otezla, and tezeplumab. But in turning to the Japanese company, Amgen is also evoking the 1984 alliance with Kyowa Kirin’s parent company, a 50-50 joint venture that developed and commercialized Epogen, which became a blockbuster biologic treatment for anemia. That alliance went on to bring several other drugs to the market. In 2018, Amgen paid $780 million to acquire Kirin Holdings’ stake in the joint venture.

“Kyowa Kirin was one of Amgen’s very first collaborators and we are delighted to be joining forces with them once again to advance this promising late-stage asset to treat atopic dermatitis,” Robert Bradway, chairman and CEO of Amgen said in a prepared statement. “We will take advantage of our two decades of experience in inflammatory disease, as well as our industry-leading human genetics capabilities, to help realize the full potential of KHK4083 as quickly as possible.”

The two companies have agreed to share in the global development costs of KHK4083, except in Japan where Kyowa Kirin holds the drug’s rights. The partners are also splitting U.S. commercialization costs. Amgen said it will also use data from its decoded Genetics subsidiary to inform the development of KHK4083 for other inflammatory indications.

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