– Results presented at EADV show baricitinib significantly improved clinical and patient-reported outcomes compared to placebo in moderate-to-severe atopic dermatitis patients

– Improvements seen as early as first week of treatment in baricitinib-treated group

– Lilly will initiate a Phase 3 clinical program for moderate-to-severe atopic dermatitis later this year

INDIANAPOLIS, IN, USA I September 14, 2017 I Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced new safety and efficacy data from a Phase 2 study of baricitinib in people with moderate-to-severe atopic dermatitis (AD). The results showed that baricitinib in combination with a mid-potency topical corticosteroid (TCS) significantly improved the signs and symptoms of AD compared to TCS alone. The results were presented in an oral presentation today at the European Academy of Dermatology and Venereology (EADV) Annual Meeting in Geneva, Switzerland.

“Atopic dermatitis has a significant impact on the quality of life, including the emotional and social wellbeing of people with the disease,” said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. “Baricitinib demonstrated clinical efficacy in a Phase 2 study in atopic dermatitis. The study was designed to understand the safety and efficacy of baricitinib in patients refractory to topical steroids. In this population, baricitinib was able to achieve improvement in both itch and skin inflammation. Based on these data, we plan to initiate a Phase 3 clinical program for atopic dermatitis later this year.”

After 16 weeks of treatment, 61 percent of patients treated with 4-mg of baricitinib in combination with TCS (n=38) achieved a 50 percent or greater reduction in their overall disease severity as measured by the Eczema Area and Severity Index (EASI-50), compared to 37 percent of patients treated with TCS alone (n=49), (p<0.05). Among patients treated with 2-mg of baricitinib in combination with TCS (n=37), 57 percent achieved EASI-50, although these results were not statistically different compared to treatment with TCS alone (p=0.065). At four weeks, 68 percent of patients treated with 4-mg baricitinib in combination with TCS and 62 percent of patients treated with 2-mg of baricitinib in combination with TCS achieved EASI-50, compared to 16 percent of patients treated with TCS alone (p<0.001).

“Importantly, in this study, patients had to fail four weeks of supervised therapy with a mid-potency topical corticosteroid before randomization, selecting for a difficult to treat patient population,” said Emma Guttman-Yassky, M.D., Ph.D., Sol and Clara Kest professor of dermatology, vice chair Department of Dermatology, director of the Center for Excellence in Eczema and director of the Laboratory of Inflammatory Skin Diseases in the Department of Dermatology at Icahn School of Medicine at Mount Sinai Medical Center in New York. “These new results suggest that baricitinib may have the potential to become an oral treatment option for patients suffering from atopic dermatitis who are unable to achieve adequate control with TCS.”

During the treatment period, treatment-emergent adverse events (TEAE) occurred in 49 percent of patients treated with TCS, 46 percent and 71 percent of the 2-mg and 4-mg baricitinib in combination with TCS groups, respectively. The most common TEAEs in the 4-mg baricitinib in combination with TCS group were upper respiratory tract infections and nasopharyngitis, headache, and increases in asymptomatic laboratory changes, namely increases in creatine phosphokinase (CPK).

INDICATIONS AND USAGE FOR OLUMIANT Therapeutic Indications Baricitinib was approved in February 2017 for the treatment of adults with moderate-to-severe-active rheumatoid arthritis in the European Union and is marketed as Olumiant

About Baricitinib Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016. Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib. Baricitinib remains under review in other markets. It is also being studied for the treatment of atopic dermatitis and systemic lupus erythematosus. The Phase 3 program for psoriatic arthritis is expected to begin in 2018.

About Atopic Dermatitis Atopic dermatitis (AD), a serious form of eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1 AD is a heterogeneous disease both clinically and biologically, but may be characterized by chronic baseline symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.2,3 AD affects approximately 1-3 percent of adults worldwide.4

Moderate-to-severe AD is characterized by intense itching, resulting in visibly damaged skin, sleep loss and a significant impact on patients’ quality of life. AD patients often experience anxiety, depression and reduced self-esteem.5 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.6

About the Baricitinib Phase 2 Clinical Trial in Atopic Dermatitis The safety and efficacy of baricitinib in patients with moderate-to-severe AD was evaluated in a Phase 2 randomized, double-blind, placebo-controlled study over 16 weeks (NCT02576938). In the trial, 124 patients were randomized 4:3:3 to placebo or baricitinib 2-mg or 4-mg once daily dose. All patients received background Triamcinolone 0.1% cream for four weeks prior to randomization, and throughout the trial as indicated by the product label and the treating physician. The primary objective of the study was the proportion of patients achieving a ≥50% improvement in EASI scores (EASI-50). The study also compared the SCORing Atopic Dermatitis (SCORAD) score and EASI total score percent change from baseline (CFB) between groups. Patient-reported outcomes (PROs) assessed at each visit included Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale (NRS) and Patient Oriented Eczema Measure (POEM).

About Incyte Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s web site at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

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 newsroom.lilly.com/social-channels.

1 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.

2 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.

3 Langan SM, Thomas KS, Williams HC. What is meant by “flare” in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.

4 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.

5 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.

6 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

SOURCE: Incyte