Eli Lilly 2012 Annual Report Download - page 38

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Ixekizumab—In January 2013, we initiated Phase III clinical trial testing for ixekizumab as a potential
treatment for psoriatic arthritis.
Liprotamase—We continue to engage in discussions with the FDA regarding future clinical trial
requirements for liprotamase. See Note 7 to the consolidated financial statements for additional
information.
Necitumumab—We will assume sole worldwide development and commercialization rights to
necitumumab following notice in the fourth quarter of 2012 from BMS to terminate the collaboration
for necitumumab in North America and Japan.
Novel basal insulin analog—In January 2013, we announced that we and Boehringer Ingelheim
adjusted the scope of our collaboration, resulting in our reassuming the sole worldwide development
and commercialization rights for the novel basal insulin analog. We also announced plans for the 2013
and 2014 initiation of the remainder of the pre-planned clinical trials for the molecule. These studies
will be conducted to support regulatory submissions and evaluate safety, efficacy, and differentiation
of the molecule. These studies are in addition to the five ongoing IMAGINE clinical trials.
Pomaglumetad Methionil—In August 2012, we announced the decision to stop ongoing Phase III
clinical studies investigating pomaglumetad methionil for the treatment of patients suffering from
schizophrenia. The decision was based on a lack of efficacy in two registration trials. The decision was
not based on any safety signals.
Ramucirumab—In October 2012, we announced that the REGARD trial, a Phase III study of
ramucirumab as a second-line treatment in patients with metastatic gastric cancer, met its primary
endpoint of improved overall survival and its secondary endpoint of increased progression-free
survival. We anticipate filing for regulatory review in the U.S. and Europe in 2013.
Solanezumab—In August 2012, we announced that the primary endpoints, both cognitive and
functional, were not met in either of the two Phase III, double-blind, placebo-controlled EXPEDITION
trials in patients with mild-to-moderate Alzheimer's disease. However, a pre-specified secondary
analysis of pooled data across both trials showed a 34 percent reduction of cognitive decline in
patients with mild Alzheimer's disease. We plan to conduct an additional Phase III study of
solanezumab in patients with mild Alzheimer's disease. Enrollment is expected to begin no later than
the third quarter of 2013.
Tabalumab—In February 2013, we announced our decision to discontinue the Phase III rheumatoid
arthritis program for tabalumab due to lack of efficacy. The decision was not based on safety
concerns. The tabalumab Phase III program for lupus is ongoing and will continue as planned.
There are many difficulties and uncertainties inherent in pharmaceutical research and development (R&D)
and the introduction of new products. A high rate of failure is inherent in new drug discovery and development.
The process to bring a drug from the discovery phase to regulatory approval can take 12 to 15 years or longer
and cost more than $1 billion. Failure can occur at any point in the process, including late in the process after
substantial investment. As a result, most research programs will not generate financial returns. New product
candidates that appear promising in development may fail to reach the market or may have only limited
commercial success. Delays and uncertainties in the FDA approval process and the approval processes in
other countries can result in delays in product launches and lost market opportunities. Consequently, it is
very difficult to predict which products will ultimately be approved and the sales growth of those products.
We manage R&D spending across our portfolio of molecules, and a delay in, or termination of, any one project
will not necessarily cause a significant change in our total R&D spending. Due to the risks and uncertainties
involved in the R&D process, we cannot reliably estimate the nature, timing, completion dates, and costs of
the efforts necessary to complete the development of our R&D projects, nor can we reliably estimate the
future potential revenue that will be generated from a successful R&D project. Each project represents only a
portion of the overall pipeline, and none is individually material to our consolidated R&D expense. While we do
accumulate certain R&D costs on a project level for internal reporting purposes, we must make significant
cost estimations and allocations, some of which rely on data that are neither reproducible nor validated
through accepted control mechanisms. Therefore, we do not have sufficiently reliable data to report on total
R&D costs by project, by preclinical versus clinical spend, or by therapeutic category.