**"Lilly's $4.5B Investment Boosts Drug Innovation and Clinical Success with EBGLYSS™"**

New data show Lilly's EBGLYSS™ (lebrikizumab-lbkz) provided sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis September 25, 2024 Monthly EGBLYSS maintenance dosing sustained clear or almost-clear skin for up to three years in the vast majority of ADvocate 1 and 2 responders Nearly 87 percent of patients taking EBGLYSS did not require either high-potency topical corticosteroids or systemic treatments during the three-year study The safety profile at three years was consistent with the previously published two-year results INDIANAPOLIS, Sept. 25, 2024 /PRNewswire/ -- More than 80 percent of adults and adolescents with moderate-to-severe atopic dermatitis who responded to EBGLYSS™ treatment at Week 16 in the ADvocate 1 and 2 monotherapy trials and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing. Eli Lilly and Company (NYSE: LLY) announced these new long-term results from the ADjoin long-term extension study, which will be presented at the European Academy of Dermatology and Venereology (EADV) Congress from Sept. 25-28 in Amsterdam, Netherlands. 1 EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity.2,3,4 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6 "The chronic and persistent signs and symptoms of atopic dermatitis affect patients' daily lives, highlighting the need for a treatment that can provide sustained, long-term relief," said Eric Simpson, M.D., M.C.R., professor of dermatology and director of clinical research at Oregon Health & Science University School of Medicine in Portland, Oregon, and senior author and investigator of the ADjoin analysis. "These three-year results provide compelling evidence of durable efficacy and a consistent safety profile, offering further long-term evidence for health care providers seeking a new biologic treatment option for their patients." Patients taking EBGLYSS who completed 52 weeks in ADvocate 1 or 2 could enroll in ADjoin for an additional 100 weeks of continued treatment (up to 152 weeks of continuous treatment). Patients in this analysis of the long-term extension trial received treatment either 250 mg every two weeks (Q2W) or once monthly (Q4W). The approved maintenance dose of EBGLYSS is 250 mg Q4W. These data presented are part of ADjoin, the long-term extension study of the EBGLYSS trials, and include participants who responded to EBGLYSS treatment at Week 16 from ADvocate 1 and ADvocate 2. 1 84 percent of these patients taking EBGLYSS once monthly and 83 percent taking EBGLYSS every two weeks maintained clear or almost-clear skin (IGA 0,1) at three years.1 87 percent of these patients taking EBGLYSS once monthly and 79 percent taking EBGLYSS every two weeks achieved or maintained at least 90 percent improvement in disease extent and severity (EASI-90) at three years.1 83 percent of these patients taking EBGLYSS once monthly and 91 percent taking EBGLYSS every two weeks did not require either high-potency topical corticosteroids or systemic treatments.1 The safety profile of these patients taking EBGLYSS in ADjoin was consistent with previous EBGLYSS studies, and no new safety signals were observed up to three years of treatment. The majority of adverse events were mild or moderate. Less than three percent of patients experienced adverse events leading to treatment discontinuation. The most common side effects of EBGLYSS were conjunctivitis, injection site reactions and shingles (herpes zoster).1 "Without adequate treatment, atopic dermatitis can leave people struggling with uncontrolled symptoms," said Mark Genovese, M.D., senior vice president of Immunology Development at Lilly. "EBGLYSS selectively targets IL-13, one of the main drivers of inflammation in eczema. These three-year data demonstrate that EBGLYSS given once monthly provides durable symptom relief for patients who need it most." Additional data from this clinical study is underway, with results to be presented at future congresses. EBGLYSS was approved in the U.S. by the Food and Drug Administration (FDA) earlier this month. EBGLYSS was also approved in the European Union in 2023, as well as in Japan in January 2024, with additional markets expected later this year. "These latest clinical data for EBGLYSS show the potential of this innovative medicine to provide sustained improvement of moderate-to-severe atopic dermatitis, a chronic and often debilitating condition," said Volker Koscielny, M.D., Chief Medical Officer at Almirall. "The data can help inform clinical decision-making and are reassuring, as they show that the vast majority of patients who respond to the treatment will continue to respond over time." Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including eczema, in Europe. About ADjoin ADjoin (NCT04392154) evaluated the long-term safety and efficacy of EBGLYSS treatment in patients with moderate-to-severe atopic dermatitis for up to 100 weeks (up to 152 weeks of continuous treatment with the parent studies). Patients taking EBGLYSS who completed any of the parent studies (ADvocate 1 and 2, ADhere, ADore, ADopt-VA) were able to enroll in ADjoin. The ADhere parent study includes patients taking topical corticosteroids with EBGLYSS as a combination therapy. Patients could also enroll directly into ADjoin without participating in a parent study. Patients in this analysis of the long-term extension trial received either EBGLYSS 250 mg every two weeks or once monthly.1 INDICATION AND SAFETY SUMMARY EBGLYSS™ (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids. It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients. Before using Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you: Have a parasitic (helminth) infection. Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS. Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy. Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Possible side effects EBGLYSS can cause serious side effects, including: Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing itching swelling of the face, lips, mouth, tongue or throat fainting, dizziness, feeling lightheaded skin rash hives cramps in your stomach area (abdomen) Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. The most common side effects of EBGLYSS include: eye and eyelid inflammation, including redness, swelling, and itching injection site reactions shingles (herpes zoster) These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. How to take See the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes. Use EBGLYSS exactly as prescribed by your healthcare provider. EBGLYSS is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver. If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time. Learn more EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you. LK CON BS AD APP EBGLYSS™ and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. About EBGLYSS EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.3,4,7 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling.5 IL-13 is implicated as a primary cytokine tied to the pathophysiology of eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.7 The EBGLYSS Phase 3 program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies. Further data results from ADmirable and ADapt are expected to be shared in 2024 and early 2025. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to severe atopic dermatitis and the timeline for future readouts, presentations, and other milestones relating to EBGLYSS and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date or that EBGLYSS will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 1 Thaci E, et al. Efficacy and Safety of Lebrikizumab is Maintained up to Three Years in Patients with Moderate-to-Severe Atopic Dermatitis: ADvocate 1, ADvocate 2, and ADjoin Long Term Extension Trial. 2024 European Academy of Dermatology and Venereology Congress. September 25, 2024. 2 Simpson EL, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863-871.e11. doi:10.1016/j.jaad.2018.01.017 3 Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7 4 Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.10116/j.jmb.2013.01.024 5 Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62. doi:10.1111/all.13954 6 Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018 7 EBGLYSS. Prescribing Information. Lilly USA, LLC. Refer to: Rachel Hoffmeyer; rachel.hoffmeyer@lilly.com; +1-463-276-8558 (Media) Joe Fletcher; jfletcher@lilly.com; +1-317-296-2884 (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/new-data-show-lillys-ebglyss-lebrikizumablbkz-provided-sustained-disease-control-for-up-to-three-years-in-more-than-80-of-adults-and-adolescents-with-moderate-to-severe-atopic-dermatitis302257401.html SOURCE Eli Lilly and Company

Lilly announces new $4.5 billion site - the Lilly Medicine Foundry - to drive innovation in drug production and make medicines for clinical trials October 2, 2024 Indiana facility will combine research, manufacturing and the latest technology to innovate new production methods and scale global access to clinical supply for Lilly's growing pipeline Opening in late 2027, the facility will increase Lilly's total capital commitment in the United States to more than $23 billion since 2020 INDIANAPOLIS, Oct. 2, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. This unique facility will give Lilly the ability to research new ways of producing medicines, while also scaling up manufacturing of medicines for clinical trials. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will be located in Indiana's LEAP Research and Innovation District in Lebanon, Indiana, and will expand the company's investment there to more than $13 billion. "As we accelerate our work to discover new medicines for the toughest diseases, we're continuing to invest in state-of-the-art infrastructure to support our growing pipeline," said David A. Ricks, Lilly's chair and CEO. "In addition to supplying high-quality medicine for our clinical studies, this new complex will further strengthen our process development and scale up our manufacturing capabilities to speed delivery of next-generation medicines to patients around the world." The Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The flexible design of this new facility will enable production of various molecular therapies, including drug substances for small molecules, biologics and nucleic acid therapies. New technologies developed at the Medicine Foundry will be transferred to Lilly's other manufacturing sites for full-scale production. The site's location in LEAP will support close collaboration with Lilly Research Laboratories' teams in Indianapolis and Lilly's manufacturing sites in Lebanon. The State of Indiana will support the new site with infrastructure improvements for roads, water, electricity and other utilities. The state will also offer economic incentives tied to Lilly's investment and employment goals in Lebanon. Once fully operational, the Medicine Foundry is expected to add 400 full-time jobs for highly skilled workers including engineers, scientists, operations personnel and lab technicians. "Lilly's continued investment in Indiana solidifies our state's role as a hub for cutting-edge science and technology," said Indiana Governor Eric J. Holcomb. "For nearly 150 years, Lilly has been committed to growing its roots and reach in Indiana, cultivating local talent, and driving scientific advancements that benefit patients around the world. I couldn't be more excited about the opportunities Lilly's Medicine Foundry will bring to communities throughout our great state." "Lilly's increased investment in Indiana is creating tremendous new career opportunities for Hoosiers," said Indiana Secretary of Commerce David Rosenberg. "The LEAP district in Lebanon is quickly becoming an international destination, with $18 billion in committed capital investment on 2,300 acres since its launch in 2022. LEAP and the Hardtech Corridor are attracting global leaders, talent and innovation to Indiana." This new facility will add to Lilly's previous manufacturing commitments in Lebanon: In May 2022, Lilly announced plans to invest $2.1 billion in two new manufacturing sites in Lebanon to expand its network for active ingredients and new modalities, such as genetic medicines. In April 2023, Lilly broke ground on these facilities and announced an additional $1.6 billion investment. In May 2024, Lilly announced an additional $5.3 billion commitment to enhance capacity to manufacture active pharmaceutical ingredients for its latest diabetes and obesity medicines. This milestone marked the largest single investment in active pharmaceutical ingredients production in U.S. history. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. C-LLY Forward-Looking Statement This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) including about planned capital investments in new manufacturing capacity and related initiatives and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the manufacturing process, development and commercialization of pharmaceutical products any of which could impact the overall commercial success of our products, and as related to cost, completion timing, expected capacity, personnel, and other factors which could impact expected benefits of the capacity expansion and related initiatives. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. # # # Additional Quote Options for Media Use U.S. Secretary of Commerce Gina Raimondo: "This kind of investment will help the United States maintain leadership in advanced manufacturing and accelerate innovation," said U.S. Secretary of Commerce Gina Raimondo. "It will complement the $51 million Tech Hubs investment the BidenHarris administration announced in July to advance Central Indiana's global leadership in biotechnology and biomanufacturing and strengthen the nation's biotechnology supply chain. Eli Lilly plays a critical role in the Central Indiana Tech Hub." U.S. Congressman Jim Banks: "Lilly's longstanding commitment to Indiana and latest investment are a testament to our state's talented workforce and innovative business environment. The Lilly Medicine Foundry will be a state-of-the-art facility that leads the world in biotechnology developments and creates hundreds of good paying jobs for Hoosiers." Refer to: Stefanie Prodouz; stefanie.prodouz@lilly.com; +1-317-287-9899 (Media) Joe Fletcher; jfletcher@lilly.com; +1-317-296-2884 (Investors) View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-announces-new-4-5-billion-site---the-lilly-medicinefoundry---to-drive-innovation-in-drug-production-and-make-medicines-for-clinical-trials-302264905.html SOURCE Eli Lilly and Company