— Strategic Partnership Strengthens Gilead’s Inflammation Research Portfolio with the Addition of LEO Pharma’s Preclinical Oral STAT6 Program, Including Targeted Protein Degraders —
— Gilead Will Have Exclusive Global Rights to the STAT6 Program, and LEO Pharma Will Have the Option to Co-Commercialize for Dermatology Indications Outside the U.S. —
— LEO Pharma to Maintain Global Rights to Topical Formulations of the STAT6 Program in Dermatology —
FOSTER CITY, CA, USA & BALLERUP, Denmark I January 11, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) andLEO Pharmatoday announced a strategic partnership to accelerate the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.
STAT6 is the specific transcription factor required for IL-4 and IL-13 cytokine signaling, which are clinically validated targets for Th2 mediated inflammatory conditions such as atopic dermatitis, asthma, and COPD, amongst many others. Targeting STAT6 has shown potential preclinically to treat a broad population of patients and provide an oral alternative to those currently treated with injectable biologics.
Under this partnership, Gilead will acquire LEO Pharma’s comprehensive preclinical oral STAT6 small molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for the oral programs, while LEO Pharma will lead development for potential topical formulations of STAT6 inhibitors.
“As we continue to expand our inflammation portfolio, we’re 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, tolerize the immune system, and restore cell function,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. “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.”
“STAT6 holds potential for treating various inflammatory diseases, including outside dermatology. This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 program and maximize its potential in dermatology and beyond,” said Christophe Bourdon, CEO of LEO Pharma. “This partnership acknowledges LEO Pharma’s scientific capabilities and strengthens our commitment to innovate for people with skin diseases.”
Terms of the Agreement
Gilead will have global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to potentially co-commercialize oral programs for dermatology outside the United States. LEO Pharma will hold exclusive global rights to STAT6 topical formulations in dermatology.
LEO Pharma is eligible to receive up to $1.7 billion in total payments, including an upfront payment of $250 million. In addition, LEO Pharma may also receive tiered royalties ranging from high single-digit to mid-teens on sales of oral STAT6 products. Gilead may receive tiered royalties ranging from high single-digit to mid-teens on sales of topical STAT6 products.
Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with LEO Pharma is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by approximately $0.15 – $0.17.
Bank of America Securities acted as financial advisors to LEO Pharma in this transaction and Latham Watkins LLP acted as legal advisors.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of $1.6 billion. Read more at www.leo-pharma.com.
SOURCE: Gilead Sciences
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— Strategic Partnership Strengthens Gilead’s Inflammation Research Portfolio with the Addition of LEO Pharma’s Preclinical Oral STAT6 Program, Including Targeted Protein Degraders —
— Gilead Will Have Exclusive Global Rights to the STAT6 Program, and LEO Pharma Will Have the Option to Co-Commercialize for Dermatology Indications Outside the U.S. —
— LEO Pharma to Maintain Global Rights to Topical Formulations of the STAT6 Program in Dermatology —
FOSTER CITY, CA, USA & BALLERUP, Denmark I January 11, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) andLEO Pharmatoday announced a strategic partnership to accelerate the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.
STAT6 is the specific transcription factor required for IL-4 and IL-13 cytokine signaling, which are clinically validated targets for Th2 mediated inflammatory conditions such as atopic dermatitis, asthma, and COPD, amongst many others. Targeting STAT6 has shown potential preclinically to treat a broad population of patients and provide an oral alternative to those currently treated with injectable biologics.
Under this partnership, Gilead will acquire LEO Pharma’s comprehensive preclinical oral STAT6 small molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for the oral programs, while LEO Pharma will lead development for potential topical formulations of STAT6 inhibitors.
“As we continue to expand our inflammation portfolio, we’re 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, tolerize the immune system, and restore cell function,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. “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.”
“STAT6 holds potential for treating various inflammatory diseases, including outside dermatology. This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 program and maximize its potential in dermatology and beyond,” said Christophe Bourdon, CEO of LEO Pharma. “This partnership acknowledges LEO Pharma’s scientific capabilities and strengthens our commitment to innovate for people with skin diseases.”
Terms of the Agreement
Gilead will have global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to potentially co-commercialize oral programs for dermatology outside the United States. LEO Pharma will hold exclusive global rights to STAT6 topical formulations in dermatology.
LEO Pharma is eligible to receive up to $1.7 billion in total payments, including an upfront payment of $250 million. In addition, LEO Pharma may also receive tiered royalties ranging from high single-digit to mid-teens on sales of oral STAT6 products. Gilead may receive tiered royalties ranging from high single-digit to mid-teens on sales of topical STAT6 products.
Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with LEO Pharma is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by approximately $0.15 – $0.17.
Bank of America Securities acted as financial advisors to LEO Pharma in this transaction and Latham Watkins LLP acted as legal advisors.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of $1.6 billion. Read more at www.leo-pharma.com.
SOURCE: Gilead Sciences
Post Views: 145
