Gilead Sciences and LEO Pharma have entered into a strategic partnership worth $1.7bn to advance LEO’s small molecule oral STAT6 programme for inflammatory diseases.
The deal gives Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US.
In exchange, LEO will be eligible for up to $1.7bn, including an upfront payment of $250m and approximately $1.5bn in development, regulatory and commercial milestones. LEO may also receive tiered royalties on sales of oral STAT6 products, while Gilead could be in line for tiered royalties on sales of topical STAT6 products.
Flavius Martin, executive vice president, research, Gilead, said the company is “committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that block major pathogenic pathways, eliminate pathogenic cells, tolerise the immune system, and restore cell function”.
“By partnering with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring forward an oral option for patients suffering from chronic inflammatory conditions,” he added.
STAT6 is the specific transcription factor used for interleukin-4 and interleukin-13 cytokine signalling, which has been shown to play a key role in multiple inflammatory conditions, including atopic dermatitis, asthma and chronic obstructive pulmonary disease.
The approach has already shown potential pre-clinically to treat a broad population of patients and provide an oral alternative to those currently receiving injectable biologics.
“STAT6 holds potential for treating various inflammatory diseases, including outside dermatology,” said LEO’s chief executive officer, Christophe Bourdon. “This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 programme and maximise its potential in dermatology and beyond.”
The announcement comes just over a month after LEO’s Anzupgo (delgocitinib) cream was approved by the Medicines and Healthcare Products Regulatory Agency to treat chronic hand eczema in adults with moderate-to-severe cases of the inflammatory skin disease.
The company is now working with the National Institute for Health and Care Excellence to make the treatment available on the NHS.