Lilly Discontinues Phase 3 Rheumatoid Arthritis Program for Tabalumab Based on Efficacy Results

Thu Feb 7, 2013 8:05am EST

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Decision not based on safety concerns; Phase 3 lupus program continues as
planned
INDIANAPOLIS,  Feb. 7, 2013  /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY)
announced today that it will discontinue the Phase 3 rheumatoid arthritis (RA)
program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal
antibody, due to lack of efficacy. The decision was not based on safety
concerns. The tabalumab Phase 3 program for systemic lupus erythematosus,
ILLUMINATE, is ongoing and will continue as planned.

In  December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-M
for lack of treatment effect. FLEX-M was investigating tabalumab in patients
with moderate-to-severe RA who had an inadequate response to methotrexate
therapy.

Based on FLEX-M findings, an interim futility analysis was conducted of the
FLEX-V study, which was investigating tabalumab for the treatment of patients
with moderate-to-severe RA who had an inadequate response to one or more tumor
necrosis factor (TNF) inhibitors.  

Based on the outcomes of these two separate interim futility analyses, Lilly has
decided to discontinue development of tabalumab in the current RA program. All
ongoing Phase 2 and Phase 3 RA studies will be stopped.

"While we are obviously disappointed by these results in rheumatoid arthritis,
we continue to believe that tabalumab could have significant potential for
patients in other disease areas," said Eiry Roberts, M.D., vice president of
autoimmune product development at Lilly. "Autoimmune disorders are highly
individualized. We believe that targeting BAFF with a molecule such as tabalumab
may still represent an important advance for patients, and therefore we will
continue the ongoing Phase 3 tabalumab lupus program."

The decision to stop the current RA program for tabalumab is expected to result
in a first-quarter charge to research and development expense of approximately 
$50 million. The company's previously issued financial guidance for 2013 remains
unchanged.

About the FLEX-V Study   
The FLEX-V study (study BCDV) is a Phase 3, multicenter, randomized,
double-blind, placebo-controlled study to evaluate the efficacy and safety of
tabalumab in patients with moderate-to-severe RA who had an inadequate response
to one or more TNF inhibitors.

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 3
development as a potential treatment for systemic lupus erythematosus and in
Phase 2 development in combination with bortezomib for patients with
previously-treated multiple myeloma.  

About Lilly's Autoimmune Pipeline   
Tabalumab is one of three potential new medicines in late-stage clinical
development for a variety of autoimmune conditions. The others are ixekizumab,
an anti-IL-17 monoclonal antibody, for psoriasis and psoriatic arthritis; and
baricitinib, a JAK1 and JAK2 inhibitor being developed in collaboration with
Incyte Corporation, for RA, psoriasis and diabetic nephropathy.

About Lilly's Pipeline    
Lilly currently has a number of unique potential medicines in its Phase 3
clinical development pipeline, representing a variety of therapeutic areas
including diabetes (four), cancer (three), neuroscience (two), autoimmunity
(three) and cardiovascular (one). To learn more about the molecules in Lilly's
clinical development pipeline, please visit Lilly's interactive pipeline website
available at  www.lilly.com/pipeline.

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 forward-looking statements about the potential of
tabalumab for the treatment of rheumatoid arthritis and lupus, 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 the compound will receive
regulatory approval, or that it 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.

P-LLY

Refer to:  Media:  Sonja Popp-Stahly, +1 317-655-2993,  spopp-stahly@lilly.com; 
 
Investors:  Phil Johnson, +1 317-655-6874,  johnson_philip_l@lilly.com

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SOURCE  Eli Lilly and Company

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