— Strategic partnership strengthens Gilead's inflammation research portfolio with addition of LEO Pharma's preclinical oral STAT6 program, including targeted protein degraders —
— Gilead will have exclusive global rights to STAT6, and LEO Pharma will have the option to co-market dermatology indications outside the U.S. —
— LEO Pharma retains global rights to topical formulations of STAT6 in dermatology —
FOSTER CITY, Calif. and BALLERUP, Denmark–(BUSINESS WIRE)– Gilead Sciences (Nasdaq: GILD) and Leo Pharma Today announced a strategic partnership to accelerate the development and commercialization of LEO Pharma's oral small molecule STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.
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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 chronic obstructive pulmonary disease, among many others. Targeting STAT6 has shown potential to treat a large number of patients preclinically and provide an oral alternative to those currently treated with injectable biologics.
Under this partnership, Gilead will acquire LEO Pharma's preclinical comprehensive oral STAT6 small molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for oral programs, while LEO Pharma will lead development of potential topical formulations of STAT6 inhibitors.
As we continue to expand our inflammatory portfolio, we are committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that inhibit key pathogenic pathways, eliminate pathogenic cells, tolerize the immune system, and restore cells. said Flavius Martin, MD, executive vice president of research at Gilead Sciences. By partnering with LEO Pharma, we hope to explore the potential of the STAT6 pathway to offer an oral option for patients with chronic inflammatory conditions.
STAT6 holds potential for the treatment of various inflammatory diseases, including external skin diseases. 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 recognizes LEO Pharma's scientific capabilities and reinforces our commitment to innovation for people with skin conditions.
Terms of agreement
Gilead will have the global rights to develop, manufacture and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to co-commercialize oral dermatology programs outside the United States. LEO Pharma will have the 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 the high single digits to the mid-teens on sales of oral STAT6 products. Gilead may receive tiered royalties ranging from the high single digits to the mid-teens on sales of topical STAT6 products.
Gilead does not exclude earned IPR and development expenses from its non-GAAP financial measures. This transaction with LEO Pharma is expected to reduce Gilead's GAAP and 2025 non-GAAP EPS by approximately $0.15-$0.17.
Bank of America Securities acted as financial advisor to LEO Pharma in this transaction, and Latham Watkins LLP served as legal advisor.
About Gilead Sciences
Gilead Sciences, Inc. (NASDAQ:) 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 developing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and infections. Gilead operates in more than 35 countries around the world and is headquartered in Foster City, California.
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 jointly owned by majority shareholder LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a wide range of therapies, serving 100 million patients annually. LEO Pharma is headquartered in Denmark and has a global team of 4,000 people. In 2023, the company achieved net sales of $1.6 billion. Read more at www.leo-pharma.com.
Gilead's forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to realize the expected benefits of the partnership; unexpected difficulties or expenses in connection with the partnership and potential impacts on Gilead's earnings; Gilead's ability to initiate, advance or complete clinical trials within currently anticipated timelines or at all, and the possibility of obtaining unfavorable results from ongoing or additional trials, including those involving programs developed pursuant to the partnership; Gilead's ability to submit applications for regulatory approval or obtain regulatory approvals in a timely manner or at all for investigational programs developed pursuant to the partnership, and the risk that any such approvals will be subject to significant restrictions on use; the possibility that Gilead may make a strategic decision to discontinue development of any investigational programs developed under the partnership, and thus such programs may never be successfully commercialized; And any assumptions underlying any of the above. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those indicated in the forward-looking statements. All statements other than statements of historical fact are statements that may be deemed to be forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead undertakes no obligation and disclaims any intention to update any such forward-looking statements.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The LEO Pharma name and logo are trademarks of LEO Pharma.
For more information about Gilead, please visit the company's website at www.gilead.comFollow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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Gilead information
Jessica Smith, media
public_affairs@gilead.com
Jackie Ross, Investors
investor_relations@gilead.com
Leo Pharma Information
Jeppe Elkjaer, Media
jeilk@leo-pharma.com
Christian Sorup Ream, Investors
chsoe@leo-pharma.com
Source: Gilead Sciences.
