Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics

Pivotal RA-BEACON Study Published in New England Journal of Medicine

INDIANAPOLIS, March 31, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced that detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis (RA) — were published today in the New England Journal of Medicine.

The study met its primary endpoint of improved ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 represents at least a 20 percent improvement across selected measures of disease activity.

ACR 20 response rates were as follows (P≤0.001 for each baricitinib dose versus placebo):

The RA-BEACON study enrolled 527 patients who previously had failed at least one tumor necrosis factor (TNF) inhibitor, and included 199 patients who also had received prior treatment with one or more non-anti-TNF biologic agents. Patients received baricitinib 2 mg or 4 mg or placebo daily, in addition to their existing background therapies, for 24 weeks.

"The findings from the RA-BEACON study suggest treatment with baricitinib is associated with meaningful improvements in RA symptoms," said Terence Rooney, M.D., Lilly's senior medical director for baricitinib. "The baricitinib clinical development program includes a wide range of patients across the RA treatment spectrum. If approved, baricitinib may be a valuable option for rheumatologists and patients who are looking for new alternatives to treat this debilitating disease."

"The RA patient community is diverse and there continues to be a need for more therapeutic options that address individual treatment needs, including in patients whose disease has not responded to TNF inhibitor therapy," said Rich Levy, M.D., Incyte's chief drug development officer.

A statistically significant improvement in ACR 20 response rate with baricitinib versus placebo was observed as early as one week (P≤0.01). ACR 50 and ACR 70 response rates were also significantly higher for baricitinib compared with placebo at week 12 (P≤0.01).

A significantly greater proportion of patients treated with baricitinib also achieved a DAS28-CRP score—a measure of RA disease activity—below 2.6 (indicating disease remission) at week 12 compared with patients receiving placebo. Additionally, a greater proportion of patients treated with baricitinib versus placebo achieved score improvements of at least 0.3 on the Health Assessment Questionnaire Disability Index (HAQ-DI)—a patient-reported assessment of physical function— at week 12.

Significant improvements in ACR response rates, DAS28-CRP and HAQ-DI that were noted with baricitinib versus placebo at week 12 were maintained through week 24.

Through 24 weeks, the rate of treatment-emergent adverse events (AEs) was higher for baricitinib 4 mg (77 percent) and baricitinib 2 mg (71 percent) than for placebo (64 percent). Discontinuation rates due to AEs were 6 percent, 4 percent and 4 percent, respectively. The most common adverse events reported for baricitinib-treated patients included headache, upper respiratory infections and nasopharyngitis. There were no opportunistic infections, cases of tuberculosis or gastrointestinal perforations. Rates of serious adverse events were 10 percent for baricitinib 4 mg, 4 percent for baricitinib 2 mg and 7 percent for placebo. One death was reported in the baricitinib 4 mg dose group (stroke).

About Baricitinib
Baricitinib is a once-daily oral selective JAK1 and JAK2 inhibitor currently in late-stage 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. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK3 in kinase assays.

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 in the U.S. and European Union in Q1 2016, and is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus.

About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Patients and physicians indicate there remains an important opportunity to improve patient care. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral disease-modifying anti-rheumatic drugs such as methotrexate, and injectable biological response modifiers that target selected mediators implicated in the pathogenesis of RA.[iv]

About Baricitinib Phase 3 Trials
Lilly and Incyte conducted four pivotal phase 3 clinical trials of baricitinib in patients with moderately-to-severely active rheumatoid arthritis to support regulatory submission in most countries. An additional phase 3 study was initiated to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate-naïve, inadequate responders to methotrexate, inadequate responders to conventional disease-modifying anti-rheumatic drugs, or inadequate responders to TNF inhibitors. Patients completing any of the five phase 3 studies can enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.

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.

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.

P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis, and reflects Lilly and Incyte's current belief. However, 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 study findings to-date, or that baricitinib will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent Form 10-K and 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

[i] American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: February 26, 2016)
[ii] Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed: February 26, 2016)
[iii] WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf (Accessed February 26, 2016)
[iv] Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php (Accessed: February 26, 2016)

Refer to: 
Scott MacGregor; jsmacgregor@lilly.com; +1-317-440-4699 (Lilly media)
Phil Johnson; johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)
Catalina Loveman; cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil; mbooth@incyte.com; +1-302-498-5914 (Incyte investors)  

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SOURCE Eli Lilly and Company; Incyte Corporation

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