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



 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 -

PR Newswire

INDIANAPOLIS, Nov. 9, 2012

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)

  o Abstract #490: Poster Session: Sunday, Nov. 11, 9 a.m.-6 p.m. ET

       o 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
       o Presenter: Josef S. Smolen, Medical University of Vienna and Hietzing
         Hospital
       o Location: Poster Hall B

  o Abstract #2487: Oral Session: Tuesday, Nov. 13, 3 p.m. ET

       o 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
       o Presenter: Mark C. Genovese, Stanford University Medical Center
       o Location: Ballroom C

  o Abstract #2488: Oral Session: Tuesday, Nov. 13, 3:15 p.m. ET

       o 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
       o Presenter: Charles G. Peterfy, Spire Sciences LLC
       o Location: Ballroom C

  o Abstract #2653: Oral Session: Wednesday, Nov. 14, 11 a.m. ET

       o A Subset of up-Regulated IFN Regulated Genes in CANDLE Patients
         Decrease with Treatment with a JAK Inhibitor
       o Presenter: Adriana Almeida de Jesus, National Institute of Arthritis
         Musculoskeletal and Skin Disease, National Institutes of Health
       o Location: 143 A

Tabalumab (LY2127399):

  o Abstract #447: Poster Session: Sunday, Nov. 11, 9 a.m.-6 p.m. ET

       o 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
       o Presenter: Maria W. Greenwald, Desert Medical Advances
       o Location: Poster Hall B

  o Abstract #1276: Poster Session: Monday, Nov. 12, 9 a.m.-6 p.m. ET

       o Changes in B Cell Populations and Serum Immunoglobulins and Their
         Relationship to Infections in a One Year, Uncontrolled Open Label
         Study of Tabalumab
       o Presenter: Maria W. Greenwald, Desert Medical Advances
       o Location: Poster Hall B

  o Abstract #1315: Poster Session: Monday, Nov. 12, 9 a.m.-6 p.m. ET

       o 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
       o Presenter: Wendy J. Komocsar, Eli Lilly and Company
       o 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).

P-LLY

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company

Website: http://www.lilly.com
Contact: Sonja Popp-Stahly, +1-317-655-2993, spopp-stahly@lilly.com
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