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Lilly to Present Pivotal Phase 3 Study Results for Investigational Psoriasis Treatment at 23rd World Congress of Dermatology
Date:6/4/2015

INDIANAPOLIS, June 4, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will showcase results from three pivotal Phase 3 studies investigating ixekizumab for the treatment of moderate-to-severe plaque psoriasis at the 23rd World Congress of Dermatology in Vancouver, British Columbia, June 8-13.

A total of nine presentations, including seven oral presentations, will report results from the UNCOVER-1, 2 and 3 clinical studies and a separate patient survey. Phase 3 data to be presented from the UNCOVER studies include efficacy and safety results comparing ixekizumab to etanercept and placebo, in addition to quality-of-life improvements observed in patients treated with ixekizumab. Patient survey data to be presented examined the impact psoriasis symptoms have on touch avoidance and quality of life.

"Psoriasis places an incredible physical, emotional and mental burden on the people it affects," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines. "We look forward to sharing detailed data about the efficacy and safety of ixekizumab, further demonstrating why we believe this investigational therapy, if approved, has the potential to help treat this challenging disease."

Data to be presented includes:

Oral Presentations

Tuesday, June 9, 1:30-3 p.m. PDT, FC-04: Psoriasis I

  • Maintenance of Efficacy Results from UNCOVER-1: A Phase 3 Trial of Ixekizumab for Moderate-to-Severe Plaque Psoriasis [Presentation FC04-07, Presenter: Gordon, K.]

  • Association of Touch Avoidance with Disease Severity and Quality of Life in Psoriasis Patients [Presentation FC04-02, Presenter: Armstrong, A.]

Wednesday, June 10, 8-9:30 a.m. PDT, FC-11: Psoriasis II

  • A Phase 3 Trial Comparing Ixekizumab with Placebo and Etanercept for Moderate-to-Severe Plaque Psoriasis: Results from the 12-Week Induction Period of UNCOVER-3 [Presentation FC11-02, Presenter: Griffiths, C.]

Thursday, June 11, 1:30-3 p.m. PDT, FC-24: Psoriasis III

  • Complete Resolution of Psoriasis is Associated with Greater Improvements in Itch and Health-Related Quality of Life: An Analysis from UNCOVER-2, a Phase 3 Clinical Trial of Ixekizumab [Presentation FC24-05, Presenter: Griffiths, C.]

  • Efficacy of Ixekizumab in Patients With and Without Previous Experience with Biologic Therapies: Results from UNCOVER-2, a Phase 3 Trial in Patients with Plaque Psoriasis [Presentation FC24-04, Presenter: Dutronc, Y.]

Friday, June 12, 1:30-3 p.m. PDT, FC-32: Psoriasis IV

  • Ixekizumab Impact on Itch Severity Compared to Etanercept and Placebo: Results from UNCOVER-2, a Phase 3 Trial in Patients with Plaque Psoriasis [Presentation FC32-04, Presenter: Yosipovitch, G.]

Saturday, June 13, 12:30-2 p.m. PDT, FC-44: Psoriasis V

  • Ixekizumab Impact on Health-related Quality of Life compared to Etanercept and Placebo: Results from UNCOVER-2, a Phase 3 Trial in Patients with Moderate-to-Severe Plaque Psoriasis [Presentation FC-44, Presenter: Toth, D.]

Posters

Tuesday, June 9 to Friday, June 12, 9 a.m.-7 p.m. PDT

  • A Phase 3 Trial Comparing Ixekizumab with Placebo and Etanercept for Moderate-to-Severe Plaque Psoriasis: Results from the 12-Week Induction Period of UNCOVER-2 [Poster no. 2983377; Lead author: Griffiths, C.]

  • Ixekizumab for Treatment of Moderate-to-Severe Plaque Psoriasis: 12-Week Results from a Phase 3 Study (UNCOVER-1) [Poster no. 2983430; Lead author: Gordon, K.]

About ixekizumab 
Ixekizumab is a monoclonal antibody with high affinity and specificity that binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A). In psoriasis, IL-17A plays a major role in driving excess keratinocyte (skin cell) proliferation and activation. Ixekizumab does not bind to cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered via subcutaneous injection (under the skin). Ixekizumab is also in clinical development for the treatment of psoriatic arthritis.

About the UNCOVER Studies 
The UNCOVER studies are double-blind, multicenter, Phase 3 studies evaluating more than 3,800 patients with moderate-to-severe psoriasis in 18 countries. UNCOVER-1 compared the safety and efficacy of different dosing regimens of ixekizumab to placebo after 12 weeks and 60 weeks of treatment. The UNCOVER-2 and 3 studies assigned patients to receive either placebo, etanercept (50 mg twice a week) or ixekizumab (80 mg every two or four weeks) for 12 weeks, following a 160 mg starting dose.

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 http://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 ixekizumab as a potential treatment for moderate-to-severe plaque psoriasis and reflects Lilly'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 similar to the results to date or that ixekizumab will receive regulatory approvals. 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.

Refer to: 

Tim Coulom; tim.coulom@lilly.com; 317-771-2241 (media)


Philip Johnson; johnson_philip_l@lilly.com; 317-655-6874 (investors)

 

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