Lilly to Present Phase II Rheumatoid Arthritis and Biomarker Data at ACR For Two Investigational Medicines to Treat Autoimmune Diseases

- Presentations include 24-week results for baricitinib and 52-week results for tabalumab -

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Nov 09, 2012, 09:00 ET

INDIANAPOLIS, Nov. 9, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will present Phase II data in rheumatoid arthritis (RA) for two of its investigational autoimmune medicines at the annual meeting of the American College of Rheumatology (ACR), which takes place Nov. 10-14, 2012, in Washington, D.C. These compounds include tabalumab, an anti-BAFF monoclonal antibody, and baricitinib, a janus kinase (JAK) inhibitor being developed in partnership with Incyte Corporation.

The abstracts showcase Lilly's data for baricitinib and tabalumab in RA across a number of areas, including efficacy and safety data, a magnetic resonance imaging (MRI) sub-study examining joint changes, patient-reported outcomes and data on novel molecular markers.

"So many people with autoimmune diseases such as rheumatoid arthritis have significant medical needs for additional treatment options, and Lilly is committed to developing potential treatments to address those needs," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "We believe the collection of data presented at ACR highlights our progress in the autoimmune space, along with the approach and strength of Lilly's autoimmune pipeline."

Studies, as well as the times and locations of the data sessions, are highlighted below.

Baricitinib (LY3009104, formerly INCB28050)

Abstract #490: Poster Session: Sunday, Nov. 11, 9 a.m.-6 p.m. ET
- 12- and 24-Week Patient-Reported Outcomes from a Phase IIb Dose-Ranging Study of Baricitinib, an Oral Janus Kinase 1 / Janus Kinase 2 Inhibitor, in Combination with Traditional Disease-Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis
- Presenter: Josef S. Smolen, Medical University of Vienna and Hietzing Hospital
- Location: Poster Hall B
Abstract #2487: Oral Session: Tuesday, Nov. 13, 3 p.m. ET
- 24-Week Results of a Blinded Phase IIb Dose-Ranging Study of Baricitinib, an Oral Janus Kinase 1 / Janus Kinase 2 Inhibitor, in Combination with Traditional Disease Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis
- Presenter: Mark C. Genovese, Stanford University Medical Center
- Location: Ballroom C
Abstract #2488: Oral Session: Tuesday, Nov. 13, 3:15 p.m. ET
- Magnetic Resonance Imaging Substudy in a Phase IIb Dose-Ranging Study of Baricitinib, an Oral Janus Kinase 1 / Janus Kinase 2 Inhibitor, in Combination with Traditional Disease-Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis
- Presenter: Charles G. Peterfy, Spire Sciences LLC
- Location: Ballroom C
Abstract #2653: Oral Session: Wednesday, Nov. 14, 11 a.m. ET
- A Subset of up-Regulated IFN Regulated Genes in CANDLE Patients Decrease with Treatment with a JAK Inhibitor
- Presenter: Adriana Almeida de Jesus, National Institute of Arthritis Musculoskeletal and Skin Disease, National Institutes of Health
- Location: 143 A

Tabalumab (LY2127399):

Abstract #447: Poster Session: Sunday, Nov. 11, 9 a.m.-6 p.m. ET
- Long-Term Safety and Efficacy of Tabalumab, an Anti-B-Cell Activating Factor Monoclonal Antibody, in Patients with Rheumatoid Arthritis: A 52-Week, Open-Label Extension Study
- Presenter: Maria W. Greenwald, Desert Medical Advances
- Location: Poster Hall B
Abstract #1276: Poster Session: Monday, Nov. 12, 9 a.m.-6 p.m. ET
- Changes in B Cell Populations and Serum Immunoglobulins and Their Relationship to Infections in a One Year, Uncontrolled Open Label Study of Tabalumab
- Presenter: Maria W. Greenwald, Desert Medical Advances
- Location: Poster Hall B
Abstract #1315: Poster Session: Monday, Nov. 12, 9 a.m.-6 p.m. ET
- Gene Expression Profiling and Pathway Changes Associated with Clinical Response to Tabalumab Blockade of Membrane Bound and Soluble B Cell Activating Factor in Rheumatoid Arthritis
- Presenter: Wendy J. Komocsar, Eli Lilly and Company
- Location: Poster Hall B

About JAK Inhibition and Baricitinib
There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. These enzymes are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in RA patients. Cytokines such as interleukin-6, -12 and -23 and both type 1 and type 2 interferons signal through the JAK/STAT pathways. Additional JAK-dependent cytokines also have been implicated in 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 is an orally administered selective JAK1 and JAK2 inhibitor that spares JAK3. Baricitinib is advancing into Phase III development as a potential treatment for rheumatoid arthritis and it is in Phase II development as a potential treatment for psoriasis and diabetic nephropathy. In December 2009, Lilly and Incyte announced an agreement for the development and commercialization of baricitinib and certain follow-on compounds for inflammatory and autoimmune diseases.

About BAFF and Tabalumab
BAFF (B cell activating factor) is a cytokine that promotes B cell survival, proliferation and activation. In the presence of excess BAFF, B cells, including autoreactive B cells, are not appropriately eliminated by the immune system and may therefore contribute to the development of RA by producing autoantibodies and proinflammatory cytokines and "helping" autoreactive T cells. BAFF exists in both membrane-bound and soluble forms.

Tabalumab is a human immunoglobulin G subclass 4 (IgG4) monoclonal antibody (MAb) that inhibits both membrane-bound and soluble B cell activating factor (BAFF). Tabalumab is currently in Phase III development as a potential treatment for rheumatoid arthritis and lupus.

About Rheumatoid Arthritis
The disease is characterized by abnormal immune mechanisms that lead to joint inflammation and swelling with progressive destruction of joints. In addition to affecting the joints, RA can also affect connective tissue in the skin and organs of the body.¹

Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral disease-modifying antirheumatic drugs such as methotrexate, and injectable biological response modifiers that target pro-inflammatory cytokines implicated in the pathogenesis of RA, such as tumor necrosis factor.

About Lilly's Autoimmune Pipeline
Lilly has established its presence in autoimmunity in just a few short years through internal research and development and partnerships. Lilly currently has three potential new medicines in clinical development for a variety of autoimmune conditions, including tabalumab for RA and lupus, ixekizumab (an anti-IL-17 monoclonal antibody) for psoriasis and psoriatic arthritis, and baricitinib for RA, psoriasis and diabetic nephropathy.

Tabalumab and ixekizumab were discovered in Lilly's research laboratories.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains certain forward-looking statements about baricitinib and tabalumab as potential treatments for patients with rheumatoid arthritis and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

¹ Arthritis Foundation, What is Rheumatoid Arthritis, http://www.arthritis.org/types-what-is-rheumatoid-arthritis.php (Accessed: October 25, 2012).

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