Eli Lilly & Co. - Special Call

Eli Lilly and Company (LLY)

April 10, 2012 10:00 am ET

Executives

Philip Johnson -

Eiry Roberts -

Subhashis Banerjee -

Michael Overdorf -

Analysts

Salim Syed - ISI Group Inc., Research Division

Gregory B. Gilbert - BofA Merrill Lynch, Research Division

Kyle Rasbach

David Risinger - Morgan Stanley, Research Division

Seamus Fernandez - Leerink Swann LLC, Research Division

Alison Yang - Barclays Capital, Research Division

Catherine J. Arnold - Crédit Suisse AG, Research Division

Presentation

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Ixekizumab Phase II Psoriasis Data Conference Call. [Operator Instructions] And as a reminder, this conference is being recorded. I would now like to turn the conference over to our host, Vice President of Investor Relations, Mr. Philip Johnson. Please go ahead.

Philip Johnson

Thank you, Connie. Good morning. Thanks for taking the time and join us for today's call. I'm Phil Johnson, Vice President of Investor Relations.

As you know, the New England Journal of Medicine recently published an article detailing Phase II results in patients with chronic plaque psoriasis treated with our anti-IL-17 monoclonal antibody, ixekizumab. Joining me today to discuss these results and to answer your questions are Dr. Eiry Roberts, Vice President of Product Development in our Bio-Medicines business with responsibility for our Autoimmune portfolio, our Bone-Muscle-Joint portfolio and Liprotamase; Dr. Subhashis Banerjee, Senior Medical Director of our Autoimmune platform and the senior author of ixekizumab NEJM article; Michael Overdorf, Global Brand Development Leader for Autoimmune biologic portfolio; and Ilissa Rassner and Travis Coy from the Investor Relations team.

Ixekizumab is one of the 12 potential new medicines that we currently have in Phase III testing. Nine of these 12 have come from our own research labs, with 2 from ImClone and 1 from Boehringer Ingelheim. Ixekizumab is also one of the 2 Phase III assets in an emerging area of focus for Lilly, autoimmune diseases. The other is our anti-BAFF monoclonal antibody, Tabalumab, which is being studied in Phase III for rheumatoid arthritis and lupus.

The remaining 10 potential new medicines in Phase III come from our traditional areas of focus: Diabetes, with our GLP-1 dulaglutide, our 2 basal insulins and the SGL T-2 inhibitor from Boehringer Ingelheim, empagliflozin; neuroscience, with solanezumab for Alzheimer's disease; pomaglumetad methionil for schizophrenia; and edivoxetine for depression; and oncology, with ramucirumab in various solid tumors; necitumumab in squamous non-small cell lung cancer; and enzastaurin in diffused large B-cell lymphoma.

The lifeblood of any pharmaceutical company is launching innovative medicines that deliver clear value for patients, physicians and payers. We're pleased with the progress we've made building a robust mid- and late-stage pipeline, predominantly, from our own internal research efforts. And we believe this pipeline positions us to drive growth post-2014. As we're doing today, we'll continue to look for opportunities to share information with you in a timely manner on the data we generate on our pipeline assets.

Now during this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to a number of factors, including those listed on Slide 2 and as outlined in our latest Forms 10-K and 10-Q filed with the Securities and Exchange Commission. The information we provide about our products and pipeline is for the benefit of the investment community. This discussion is not intended to be promotional in nature. Ixekizumab has not yet been submitted to regulatory agencies for potential approval and is still being evaluated for safety and efficacy.

Now I'll turn the call over to Dr. Eiry Roberts. Eiry?

Eiry Roberts

Thanks, Bill. It's a pleasure to have the opportunity to discuss ixekizumab with you today. Our team is encouraged about the data we have generated to date with this molecule, and we're motivated by the prospect of helping provide a new treatment option for patients with psoriasis.

First, I'll provide a brief overview of psoriasis and the role IL-17 may play in the disease, then some highlights on ixekizumab and an overview of the design of our Phase II psoriasis trial. Then Dr. Subhashis Banerjee will review the safety and efficacy findings from the Phase II study, and Michael Overdorf will conclude our prepared remarks with a brief overview of our development plan.

As you may know, psoriasis is thought to be an autoimmune disease, in which immune cells in the body incorrectly identify skin cells as pathogens and become activated. This process leads to production of inflammatory mediators by the immune cells and abnormal accumulation of skin cells. It is estimated that psoriasis affects roughly 7.5 million people in the U.S. alone, making it the most prevalent chronic autoimmune disorder.

Plaque psoriasis is the most common form of psoriasis. It often appears as raised red patches covered with a silvery white buildup of dead skin cells and can affect the skin on any part of the body. The National Psoriasis Foundation has estimated that about 17% of patients with psoriasis have moderate to severe plaque psoriasis, which requires treatment with systemic agents. This is the patient population studied in our Phase II trial.

From a mechanistic perspective, the underlying pathology or cause of psoriasis is not fully known. Psoriasis is characterized by inflammation, which, as I alluded to earlier, is thought to be the consequence of activation of immune cells, particularly T cells. Specific T cells called type 17 helper T cells, as well as gamma delta T cells and other immune cell types, secrete interleukin-17A or IL-17, which is a pro-inflammatory cytokine. IL-17 is found in elevated levels in lesional psoriatic skin. In summary, therefore, this is the basis for targeting and neutralizing IL-17 as an approach to treat psoriasis. Lilly is currently one of several biopharmaceutical companies actively pursuing this target in clinical testing.

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