Date: December 13, 2012
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 One of Three Phase 3 Rheumatoid Arthritis
Registration Studies
for Tabalumab
FLEX-M study did not meet efficacy expectationsin an interim
futility analysis;
discontinuation not based on safety concerns
INDIANAPOLIS - Eli Lilly and
Company (NYSE: LLY) announced today that it will stop one of three
Phase 3 rheumatoid arthritis (RA) registration studies of
tabalumab, an anti-BAFF monoclonal antibody, due to insufficient
efficacy. The decision followed a planned interim futility analysis
of the FLEX-M study investigating tabalumab, also known as
LY2127399, for the treatment of patients with moderate-to-severe RA
who had an inadequate response to methotrexate therapy. The
decision was not based on safety concerns, and patients currently
enrolled in other tabalumab RA studies will continue treatment.
The FLEX-M study was designed to support registration of
tabalumab as a potential treatment for RA, including an assessment
of its effect on structural progression. Lilly continues to
evaluate tabalumab in two other Phase 3 RA registration studies as
well as an open-label extension study and several other smaller
studies. Lilly is suspending enrollment of new patients in the RA
program until additional analysis from other ongoing RA studies is
completed in early 2013. These other studies are in different
patient populations.
Phase 3 studies for systemic lupus erythematosus are ongoing and
will continue to enroll new patients. Currently, there is no
evidence to suggest that efficacy results from the FLEX-M study in
RA are indicative of potential efficacy in the lupus population.
Lilly remains committed to the ongoing Phase 3 lupus program.
"The results of this study were unexpected given the data
generated in earlier Phase II clinical studies of tabalumab," said
Eiry Roberts, M.D., vice president of autoimmune product
development at Lilly. "We remain committed to patients with
rheumatoid arthritis and lupus and will move rapidly to evaluate
the impact of these data on the overall tabalumab clinical
development program. Beyond tabalumab, Lilly will continue to
develop additional treatment options for patients with autoimmune
diseases."
The decision to stop the FLEX-M study is expected to result in a
fourth-quarter charge in the range of $20
million to $35 million (pre-tax), or approximately
$0.02 per share (after-tax). The
company's previously issued financial guidance for 2012 remains
unchanged.
About the FLEX-M Study
The FLEX-M study (study BCDM) 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 rheumatoid arthritis who had an inadequate
response to methotrexate therapy. This pivotal registration study
includes the assessment of the effect of tabalumab on structural
progression.
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 rheumatoid
arthritis and systemic lupus erythematosus.
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 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
# # #
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
