INDIANAPOLIS, Oct. 2, 2014 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today it will discontinue
development of tabalumab -- being studied for the treatment of
systemic lupus erythematosus (SLE, commonly known as lupus) -- due
to insufficient efficacy in two pivotal Phase 3 trials. The
decision was not based on safety concerns.
In the ILLUMINATE 1 study, tabalumab did not achieve the primary
endpoint, at either dose studied, of statistically significant
improvement on SRI-5 (SLE Responder Index-5, a measurement of lupus
disease activity and response), compared to standard of care
therapy. In ILLUMINATE 2, the higher dose of tabalumab met this
endpoint, the first time a lupus study has achieved this efficacy
measure as a primary endpoint in a Phase 3 trial. Collectively, the
data from these studies did not meet expectations for efficacy in
the context of existing treatments. The overall safety profile
showed a similar frequency of adverse events in patients treated
with either tabalumab or standard of care. Lilly intends to submit
these data for disclosure in appropriate upcoming scientific
venues.
Given the overall efficacy results from these two pivotal Phase
3 studies, Lilly will not move forward with submissions to global
regulators. Lilly will work with investigators to appropriately
conclude these studies in the interest of patient safety.
"Although we were pleased that tabalumab met the criteria for
statistically significant improvement in the SRI-5 endpoint in one
of our trials, we are nonetheless disappointed that the overall
results did not meaningfully improve the condition of the patients
in these studies," said J. Anthony
Ware, M.D., Senior Vice President, Product Development,
Lilly Bio-Medicines. "The ILLUMINATE trials are the largest Phase 3
clinical studies in lupus to date, and we are hopeful that our
contribution of the extensive data from these studies will advance
knowledge to enhance treatment in this devastating illness. Lilly
remains committed to developing potential new medicines for the
treatment of autoimmune conditions, including lupus."
The decision to discontinue development of tabalumab for lupus
is expected to result in a third-quarter charge to research and
development expense of up to $75
million (pretax), or approximately $0.04 - $0.05 per share (after-tax).
About systemic lupus erythematosus (SLE)
Systemic
lupus erythematosus (also known as lupus) is a chronic, autoimmune
disease that can damage any part of the body (skin, joints, and/or
organs inside the body), and can range from mild to
life-threatening. The Lupus Foundation of America estimates that up
to 1.5 million people in the United
States and 5 million people throughout the world have a form
of lupus. Lupus strikes mostly women of childbearing age (15-44),
though men, children, and teenagers also develop lupus. Most people
develop lupus between the ages of 15-44.1
About Eli Lilly and Company (NYSE: LLY)
Lilly is a
global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than
a century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
http://newsroom.lilly.com/social-channels.
P-LLY
This press release contains forward-looking statements about
tabalumab as a potential treatment for systemic lupus erythematosus
and reflects Lilly's current belief. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
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 Lupus Foundation of America:
http://www.lupus.org/answers/entry/what-is-lupus (Accessed
September 29, 2014)
Refer
to:
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Media: J. Scott
MacGregor, jsmacgregor@lilly.com, +1-317-440-4699
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Investors: Phil
Johnson, johnson_philip_l@lilly.com, +1-317-655-6874
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SOURCE Eli Lilly and Company