US-based Eli Lilly and Company has signed an exclusive licence and collaboration agreement with Hanmi Pharmaceutical to develop and commercialise an immunological therapy.

Under the deal, both firms will develop Hanmi’s oral Bruton’s tyrosine kinase (BTK) inhibitor, HM71224, to treat autoimmune and other diseases.

The small molecule is ready for Phase II trial, and the firms are also planning to investigate the molecule for other applications, including rheumatoid arthritis, lupus, lupus nephritis, Sjögren’s syndrome, and other related conditions.

Eli Lilly and Company biotechnology and immunology research senior vice-president Dr Thomas Bumol said: “Significant unmet medical need exists in many prevalent autoimmune diseases where individual patient needs are not adequately being met with available treatments.

“Lilly is committed to changing patient expectations in some of the world’s most debilitating disease areas, and we’re building a portfolio of potential advances in immunology through our own research and key collaborations such as with Hanmi.”

“HM71224 is a potent and effective BTK inhibitor and has successfully demonstrated proof of mechanism in preclinical studies and a Phase I study in Europe.”

Hanmi Pharmaceutical CEO and president Dr Gwan Sun Lee said: “HM71224 is a potent and effective BTK inhibitor and has successfully demonstrated proof of mechanism in preclinical studies and a Phase I study in Europe.”

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Under the terms of the agreement, Lilly is eligible to receive worldwide rights to the molecule for all indications, except China, Hong Kong, Taiwan, and Korea.

Lilly will take responsibility for the development, regulatory, manufacturing and commercial leadership of the molecule in its territories.

The deal will allow Hanmi to secure an initial payment of $50m and is eligible for up to $640m in potential development, regulatory and sales milestones.

The company will also be eligible for tiered double-digit royalty payments, if the BTK inhibitor is successfully commercialised.

Image: Eli Lilly headquarters. Photo: courtesy of Guanaco152003.