Edesa Biotech Signs Japan Licensing Agreement With Kyorin for Paridiprubart Worth Up to $146 Million

Edesa Biotech, Inc. (NASDAQ:EDSA) has entered into an exclusive licensing and collaboration agreement with KYORIN Pharmaceutical Co., Ltd. for the development and commercialisation of paridiprubart in Japan, with potential upfront and milestone payments totalling approximately $146 million.

Under the agreement, Kyorin will receive exclusive rights to develop and commercialise paridiprubart, also known as EB05, for the treatment of acute respiratory distress syndrome (ARDS) in Japan.

Edesa will receive an upfront payment of $12 million and is eligible for additional development, regulatory and sales-related milestone payments of up to approximately $134 million. The company will also receive tiered double-digit royalties on net sales in Japan, subject to the agreement’s terms.

Kyorin to Fund Development and Commercialisation in Japan

Kyorin will assume responsibility for funding clinical development, regulatory activities and commercialisation of paridiprubart in Japan.

The agreement also grants Kyorin a right of first negotiation for the treatment of acute kidney injury (AKI), alongside a non-exclusive right to negotiate additional potential indications.

Edesa will remain responsible for manufacturing and supplying paridiprubart to Kyorin and will retain all development and commercialisation rights outside Japan.

The arrangement provides Edesa with an upfront payment and potential future revenue linked to development milestones, regulatory approvals and commercial sales.

Phase 3 Study Reports Reduction in Mortality

Paridiprubart is an investigational monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4), which plays a role in the body’s innate immune response.

In a Phase 3 study involving hospitalised patients with respiratory failure, paridiprubart administered alongside standard care demonstrated a statistically significant reduction in 28-day mortality compared with placebo.

The adjusted mortality risk was 39% among patients receiving paridiprubart, compared with 52% in the placebo group (p<0.001).

According to the companies, the treatment benefit remained statistically significant at 60 days (p=0.003), while the safety profile was described as comparable to placebo.

Paridiprubart is also being evaluated in a US government-funded platform study for ARDS and has received two funding awards from the Government of Canada.

Kyorin Expands Respiratory Medicine Development Portfolio

Yutaka Ogihara, President and Chief Executive Officer of Kyorin Pharmaceutical, commented on the licensing agreement.

“We are pleased, as a company with a strong foundation in respiratory medicine, to secure the exclusive rights to develop and commercialize EB05 in Japan,” Ogihara said.

The agreement establishes Kyorin as Edesa’s development and commercialisation partner for paridiprubart in Japan, while Edesa retains rights to pursue the drug candidate in other markets.

Future payments beyond the $12 million upfront amount will depend on the achievement of specified milestones, while potential royalties will be linked to net sales in Japan.

Paridiprubart remains an investigational treatment, and its commercialisation will depend on the completion of applicable development and regulatory requirements.

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