Gilead and LEO Pharma Partner to Advance Oral STAT6 Program for Inflammatory Diseases

Gilead Sciences, Inc., a prominent biopharmaceutical firm, has teamed up with LEO Pharma to enhance the development and commercialization of LEO Pharma’s oral STAT6 programs. This strategic collaboration aims to accelerate advancements in the treatment of inflammatory diseases, potentially benefiting a broad range of patients with conditions such as atopic dermatitis, asthma, and chronic obstructive pulmonary disease (COPD).

STAT6 is a crucial transcription factor involved in IL-4 and IL-13 cytokine signaling, which are well-validated targets for Th2-mediated inflammatory conditions. By targeting STAT6, there is the potential for a wide-ranging impact on patients, offering a promising oral alternative to those currently relying on injectable biologics.

Under this partnership, Gilead will acquire LEO Pharma’s preclinical oral STAT6 small molecule inhibitors and targeted protein degraders. Gilead will spearhead the development of the oral programs, while LEO Pharma will focus on developing potential topical formulations of STAT6 inhibitors. This partnership aligns with Gilead’s commitment to expanding its inflammation portfolio and developing next-generation therapies aimed at achieving long-term remission in patients with inflammatory diseases.

Flavius Martin, M.D., Executive Vice President of Research at Gilead Sciences, emphasized the importance of exploring the STAT6 pathway to provide an alternative oral option for managing chronic inflammatory conditions. Christophe Bourdon, CEO of LEO Pharma, highlighted the potential of STAT6 in treating various inflammatory diseases beyond dermatology, expressing enthusiasm for accelerating the development of the STAT6 program through this collaboration with Gilead.

This agreement grants Gilead global rights to develop, manufacture, and commercialize the oral STAT6 program, while LEO Pharma retains the option to potentially co-commercialize these oral programs for dermatology outside the United States. LEO Pharma will also maintain exclusive global rights to STAT6 topical formulations in dermatology.

LEO Pharma stands to receive up to $1.7 billion in total payments, which includes an upfront payment of $250 million. Additionally, LEO Pharma may earn tiered royalties ranging from high single-digit to mid-teens on sales of oral STAT6 products. Conversely, Gilead could earn tiered royalties, also ranging from high single-digit to mid-teens, on sales of topical STAT6 products.

Gilead anticipates that this transaction will slightly reduce its 2025 earnings per share by approximately $0.15 to $0.17 on both GAAP and non-GAAP bases. LEO Pharma received financial advice from Bank of America Securities and legal counsel from Latham & Watkins LLP for this transaction.

Gilead Sciences, with a history of over three decades in breakthrough medical innovations, is committed to creating a healthier world through preventive and treatment strategies for life-threatening diseases, including HIV, viral hepatitis, and cancer. Headquartered in Foster City, California, Gilead operates in more than 35 countries globally.

LEO Pharma, dedicated to advancing care standards for those with skin conditions, is co-owned by the LEO Foundation and Nordic Capital. The company serves 100 million patients annually with a global team of 4,000 people, generating net sales of $1.6 billion in 2023. Headquartered in Denmark, LEO Pharma continues to lead in dermatological innovation.