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吉利德和LEO Pharma达成战略合作伙伴关系,加快开发具有多种炎症性疾病潜力的口服STAT6项目

Gilead and LEO Pharma Enter Into Strategic Partnership to Accelerate Development of Oral STAT6 Program With Potential in Multiple Inflammatory Diseases

businesswire 等信源发布 2025-01-11 23:00

可切换为仅中文


FOSTER CITY, Calif. & BALLERUP, Denmark--(

加利福尼亚州福斯特城和丹麦巴勒鲁普--(

BUSINESS WIRE

商业热线

)--

)--

Gilead Sciences, Inc

吉利德科学公司

. (Nasdaq: GILD) and

(纳斯达克:GILD)和

LEO Pharma

利奥制药

today 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.

今天宣布了一项战略合作伙伴关系,以加速LEO Pharma小分子口服STAT6(信号转导和转录激活因子6)计划的开发和商业化,以潜在治疗炎症性疾病患者。

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..

STAT6是IL-4和IL-13细胞因子信号传导所需的特异性转录因子,它们是Th2介导的炎症性疾病如特应性皮炎,哮喘和COPD等的临床验证靶标。靶向STAT6在临床前已显示出治疗广泛患者的潜力,并为目前接受注射生物制剂治疗的患者提供了口服替代品。。

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..

在这一合作关系下,吉利德将收购利奥制药的综合临床前口服STAT6小分子抑制剂和靶向蛋白质降解剂。吉利德将领导口服项目的进一步开发工作,而利奥制药将领导STAT6抑制剂潜在局部制剂的开发。。

“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.

Gilead Sciences研究执行副总裁Flavius Martin医学博士说:“随着我们继续扩大炎症组合,我们致力于开发下一代疗法,通过阻断主要致病途径,消除致病细胞,耐受免疫系统和恢复细胞功能的机制,支持炎性疾病患者的长期缓解。”。

“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.”.

“通过与LEO Pharma合作,我们希望探索STAT6途径的潜力,为患有慢性炎症的患者提供口服选择。”。

“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.

LEO Pharma首席执行官克里斯托夫·波登(ChristopheBourdon)表示:“STAT6具有治疗各种炎症性疾病的潜力,包括皮肤科以外的疾病。与吉利德的这种战略合作将使我们能够加速STAT6计划的发展,并最大限度地发挥其在皮肤科及其他领域的潜力。”。

“This partnership acknowledges LEO Pharma’s scientific capabilities and strengthens our commitment to innovate for people with skin diseases.”.

Terms of the Agreement

协议条款

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..

吉利德将拥有开发、制造和商业化小分子口服STAT6计划的全球权利。利奥制药(LEO Pharma)将有可能在美国以外的地方共同商业化皮肤病学口腔项目。LEO Pharma将拥有STAT6皮肤科外用制剂的全球独家权利。。

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..

利奥制药有资格获得总额高达17亿美元的付款,其中包括2.5亿美元的预付款。此外,LEO Pharma还可能因销售口服STAT6产品而获得从高个位数到十几岁不等的分层版税。Gilead可能会因销售热门STAT6产品而获得从高个位数到十几岁不等的分层版税。。

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.

吉利德不将收购的知识产权和开发费用排除在其非GAAP财务指标之外。与利奥制药的这笔交易预计将使吉利德2025年的一般公认会计准则和非一般公认会计准则每股收益减少约0.15-0.17美元。

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

在此次交易中,美国银行证券担任LEO Pharma的财务顾问,Latham Watkins LLP担任法律顾问。

About Gilead Sciences

关于吉利德科学

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.

吉列德科学公司是一家生物制药公司,三十多年来一直致力于医学领域的突破,目标是为所有人创造一个更健康的世界。该公司致力于推进创新药物,以预防和治疗威胁生命的疾病,包括艾滋病毒、病毒性肝炎、新型冠状病毒肺炎、癌症和炎症。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif..

吉利德在全球35多个国家开展业务,总部位于加利福尼亚州福斯特城。。

About LEO Pharma

关于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.

利奥制药(LEO Pharma)是一家全球性公司,致力于通过创新提高护理标准,造福皮肤病患者。利奥制药由大股东利奥基金会(LEO Foundation)和北欧资本(Nordic Capital)于2021年共同拥有。利奥制药提供广泛的治疗组合,每年为1亿患者提供服务。

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 .

LEO Pharma总部位于丹麦,拥有4000人的全球团队。2023年,该公司净销售额为16亿美元。更多信息,请访问。

www.leo-pharma.com

.

.

Gilead Forward-Looking Statements

吉利德前瞻性声明

This press release includes 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 anticipated benefits from the partnership; difficulties or unanticipated expenses in connection with the partnership and the potential effects on Gilead’s earnings; the ability of Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving programs developed pursuant to the partnership; the ability of Gilead to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all for the investigational programs developed pursuant to the partnership, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of any of the investigational programs developed pursuant to the partnership, and therefore these programs may never be successfully commercialized; and any assumptions underlying any of the foregoing.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明,这些声明受到风险、不确定性和其他因素的影响,包括吉利德实现合伙企业预期收益的能力;与合伙企业有关的困难或意外费用以及对吉利德收益的潜在影响;吉利德在目前预期的时间表内启动、进展或完成临床试验的能力,以及正在进行或额外试验(包括涉及根据合作伙伴关系开发的项目)产生不利结果的可能性;吉利德能够及时提交监管批准申请或获得监管批准,或完全能够获得根据合伙企业开发的调查计划的监管批准,以及任何此类批准可能受到重大使用限制的风险;吉利德可能会做出战略决定,停止开发根据合作伙伴关系开发的任何研究计划,因此这些计划可能永远不会成功商业化;以及基于上述任何一项的任何假设。

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, 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 referred to in the forward-looking statements.

这些和其他风险、不确定性和其他因素在吉利德提交给美国证券交易委员会的截至2024年9月30日的季度10-Q表季度报告中有详细描述。这些风险、不确定性和其他因素可能导致实际结果与前瞻性声明中提及的结果存在重大差异。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statemen.

除历史事实陈述外的所有陈述均为可被视为前瞻性陈述的陈述。读者要注意的是,任何这样的前瞻性政治家。

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.

Gilead和Gilead徽标是Gilead Sciences,Inc.或其关联公司的商标。LEO Pharma的名称和徽标是LEO Pharma的商标。

For more information about Gilead, please visit the company’s website at

有关吉利德的更多信息,请访问公司网站

www.gilead.com

www.gilead.com

, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

,在X/Twitter(@Gilead Sciences)和LinkedIn(@Gilead Sciences)上关注Gilead。