Lilly Discontinues Phase 3 Rheumatoid Arthritis Program for Tabalumab Based on
Decision not based on safety concerns; Phase 3 lupus program continues as
INDIANAPOLIS, Feb. 7, 2013
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
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 Phase3
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 ofpharmaceutical 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
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.
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SOURCE Eli Lilly and Company
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