Lilly to Showcase New Data at Digestive Disease Week 2018 for Mirikizumab in Moderate-to-Severe Ulcerative Colitis

INDIANAPOLIS, June 1, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced that it will present new data evaluating mirikizumab for the treatment of moderate-to-severe ulcerative colitis (UC) at Digestive Disease Week (DDW), taking place June 2-5, 2018, in Washington, D.C.

Mirikizumab is an investigational IL-23p19 monoclonal antibody. Lilly is conducting two Phase 2 trials evaluating mirikizumab for the treatment of moderate-to-severe UC and Crohn's disease (CD).

The Phase 2 safety and efficacy results for mirikizumab, which will be presented from the podium on June 5 at DDW, will be the first public disclosure related to IL-23p19 treatment of moderate-to-severe UC. In addition to the podium presentation, Lilly will release three poster presentations detailing real world experience for patients with UC and CD, as well as data on the burden of worsening symptoms for patients with UC.

"Millions of people globally are affected by inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and many are still looking for a treatment that works for them–particularly one that addresses the life-altering symptoms of UC," said Lotus Mallbris, M.D., vice president, immunology platform team leader, Lilly Bio-Medicines. "At Lilly, we are committed to identifying new ways to deliver outcomes that meet the needs of people living with these challenging diseases. We are proud to present these data at DDW and look forward to continuing the ongoing clinical research and development of mirikizumab as a potential treatment for inflammatory diseases, including UC, psoriasis and Crohn's disease."

The podium presentation and posters to be presented are highlighted below:

Tuesday, June 5

• Abstract #882: 10:15-10:30 a.m. ET, Room 146A
• Efficacy and Safety of Anti-Interleukin-23 Therapy with Mirikizumab (LY3074828) in Patients with Moderate-To-Severe Ulcerative Colitis in a Phase 2 Study
• Presenter: William J. Sandborn, University California San Diego, La Jolla, CA, United States

Posters

• Abstract #1914: Real World Use of Oral Corticosteroids ≥30mg/Day: Characteristics of Users with Newly Diagnosed Crohn's Disease
• Abstract #1915: Real World Use of Oral Corticosteroids ≥30 Mg/Day: Characteristics of Users with Newly Diagnosed Ulcerative Colitis
• Abstract #1935: The Burden Associated with Temporal Worsening of Symptoms from the UC Patient Perspective

About Mirikizumab
Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune mediated inflammatory diseases including psoriasis, Ulcerative Colitis and Crohn's Disease.

About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that affects the colon.[1] UC occurs when the immune system sends white blood cells into the lining of the intestines, where they produce chronic inflammation and ulcerations.1 UC affects millions of patients globally.[2] Early and sustained symptom relief, improvement in the appearance of the mucosa, and clinical remission are important treatment goals for healthcare providers and patients.2 There is an unmet need for treatment options for UC that provide meaningful symptom relief and deliver sustained clinical remission.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for patients with ulcerative colitis and Crohn's disease, and reflects Lilly's current belief. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that mirikizumab will receive regulatory approvals, or be commercially successful. 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.

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¹ What is Ulcerative Colitis? Crohn's and Colitis Foundation Website. http://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/. Accessed June 1, 2018. 
² Adelphi Data 2017.

SOURCE Eli Lilly & Company

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