Gilead and Leo Pharma Enter into Strategic Partnership to Accelerate Development of Oral STAT6 Program for Multiple Inflammatory Diseases

— Strategic partnership strengthens Gilead’s inflammation research portfolio with addition of Leo Pharma’s preclinical oral STAT6 program including targeted protein inhibitors —

— Gilead will have exclusive global rights to the STAT6 program, and LEO Pharma will have a co-marketing option for dermatology indications outside the US —

— LEO Pharma secures global rights to STAT6 program in dermatology —

Foster City, Calif. and Ballerup, Denmark–( BUSINESS WIRE )–Gilead Sciences, Inc. (Nasdaq: GILD ) and LEO Pharma Today, Leo Pharma announced a strategic partnership to accelerate the development and commercialization of an oral STAT6 (signal transducer and activator of transcription 6) small molecule for patients with inflammatory diseases.

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STAT6 is a specialized transcription factor required for IL-4 and IL-13 cytokine signaling, which have been clinically proven to cause Th2-mediated inflammatory conditions such as atopic dermatitis, asthma, and COPD, among many others. Targeting STAT6 has shown potential to treat many patients and provide an oral alternative to those currently treated with injectable biologics.

Through this partnership, Gilead will acquire Leo Pharma’s generic preclinical portfolio of oral STAT6 small molecule inhibitors and targeted protein inhibitors. Gilead will lead additional development efforts for oral programs, while LEO Pharma will lead development for topical preparations that are potential STAT6 inhibitors.

As we expand our tumor portfolio, we are committed to supporting long-term remission in patients with inflammation with key pathogen-eliminating, pathogen-eliminating, immune-suppressing, and cell-restoring therapies. Action, said Flavius ​​Martin, MD, Executive Vice President, Research, Gilead Sciences. In collaboration with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring an oral alternative to patients suffering from chronic inflammation.

STAT6 has the potential to treat a variety of inflammatory diseases, including exogenous dermatoses. This strategic partnership with Gilead will allow us to accelerate the development of the STAT6 program and maximize its potential in dermatology and beyond,” said Christophe Borden, CEO of Leo Pharma. This partnership recognizes LEO Pharma’s scientific capabilities and reinforces our commitment to innovate for people with skin diseases.

Terms of the agreement

Gilead will have worldwide rights to develop, manufacture and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to co-sell oral programs for dermatology outside the United States. LEO Pharma holds the exclusive international rights to STAT6 topical formulations in dermatology.

LEO Pharma is eligible to receive total payments of up to $1.7 billion, including an upfront payment of $250 million. In addition, LEO Pharma may receive royalty payments in the high single digits to mid-tens on sales of oral STAT6 products. Gilead may receive royalties on current sales of STAT6 products ranging from the high single digits to the mid-teens.

Gilead does not exclude acquired IPR&D costs from non-GAAP financial measures. This transaction with LEO Pharma is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by $0.15 – $0.17.

Bank of America Securities served as financial advisors to LEO Pharma in this transaction and Latham Watkins LLP served as legal advisors.

About Gilead Sciences

Gilead Sciences, Inc. The company is committed to developing new 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, California.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for people with skin problems through innovation. LEO Pharma is owned by the majority shareholders of the LEO Foundation and from 2021 by Nordic Capital. LEO Pharma offers a broad portfolio of therapies serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. By 2023, the company will have net sales of $1.6 billion. Read more at www.leo-pharma.com.

Gilead’s forward-looking statements

This press release Forward-looking statements within the meaning of the Private Securities Litigation Amendment Act of 1995 are subject to risks, uncertainties and other matters, including Gilead’s ability to realize expected benefits from the joint venture. difficulties or unexpected costs related to the partnership and Gilead’s revenues; Gilead’s ability to initiate, develop or complete clinical trials within the currently expected time frame or at all, and the likelihood of obtaining positive results from ongoing or additional trials, including programs developed under partnerships; Gilead’s ability to submit applications for regulatory approval or receive regulatory approvals in a timely manner or at all for investigational programs developed under the partnership and such approvals may result in significant restrictions on use, Gilead may make a strategic decision to cease development of any investigational programs developed under the partnership, and therefore successfully commercialize these programs. They cannot be approached. and any of the above assumptions. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, 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 forward-looking statements. The reader is cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and should not place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead undertakes no obligation and has no intention of updating any forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or are trademarks of 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 (@GileadSciences) and LinkedIn (@GileadSciences).

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Gilead information
Jessica Smith, media
public_affairs@gilead.com

Jacquie Ross, investors
investor_relations@gilead.com

LEO Pharma Information
Jeppe Ilkjaer, media
jeilk@leo-pharma.com

Christian Soerup Ryom, investors
chsoe@leo-pharma.com

Source: Gilead Sciences Inc