Date: February 7, 2013
For Release: Immediately
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
Lilly Discontinues Phase 3 Rheumatoid Arthritis Program
for Tabalumab Based on Efficacy Results
Decision not based on safety concerns;
Phase 3 lupus program continues as planned
INDIANAPOLIS - 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
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Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com