Eli Lilly 2010 Annual Report Download - page 30

FORM 10-K
appear promising in development may fail to reach the market or may have only limited commercial success
because of efficacy or safety concerns, inability to obtain necessary regulatory approvals, limited scope of approved
uses, difficulty or excessive costs to manufacture, or infringement of the patents or intellectual property rights of
others. Delays and uncertainties in the U.S. Food and Drug Administration (FDA) approval process and the approval
processes in other countries can result in delays in product launches and lost market opportunity. Consequently, it is
very difficult to predict which products will ultimately be approved and the sales growth of those products.
We manage research and development spending across our portfolio of molecules, and a delay in, or termination of,
one project will not by itself necessarily cause a significant change in our total research and development spending.
Due to the risks and uncertainties involved in the research and development process, we cannot reliably estimate
the nature, timing, completion dates, and costs of the efforts necessary to complete the development of our research
and development projects, nor can we reliably estimate the future potential revenue that will be generated from a
successful research and development project. Each project represents only a portion of the overall pipeline and none
are individually material to our consolidated research and development expense. While we do accumulate certain
research and development costs on a project level for internal reporting purposes, we must make significant cost
estimations and allocations, some of which rely on data that is neither reproducible nor validated through accepted
control mechanisms. As a consequence, we do not have sufficiently reliable data to report on total research and
development costs by therapeutic category.
New molecular entities currently in Phase III clinical trial testing include the following:
BAFF antibody—an anti-BAFF antibody for the treatment of rheumatoid arthritis and lupus
BI10773—a SGLT-2 inhibitor for the treatment of diabetes (in collaboration with Boehringer Ingelheim)
Enzastaurin—a small molecule for the treatment of diffuse large B-cell lymphoma
GLP-1 Fc—a glucagon-like peptide 1 analog for the treatment of type 2 diabetes
Necitumumab—a fully human monoclonal antibody being investigated as a treatment for non-small cell lung
cancer
NERI—a potent and highly selective norepinepherine reuptake inhibitor being investigated as a treatment for
major depression
Ramucirumab—a monoclonal antibody being investigated as a treatment for metastatic breast and gastric
cancers
Solanezumab—an amyloid beta (Aß) antibody for the treatment of Alzheimer’s disease
New molecular entities that have been submitted for regulatory review include the following:
Arxxant—a potential treatment for diabetic retinopathy
Florbetapir—a molecular imaging tool under investigation for the detection of beta-amyloid plaque in the brain.
The absence of beta-amyloid plaque in the brain makes a diagnosis of Alzheimer’s disease unlikely.
Linagliptin—a DPP-4 inhibitor for the treatment of diabetes (in collaboration with Boehringer Ingelheim)
Liprotamase—a non-porcine pancreatic enzyme replacement therapy
The following are late-stage pipeline developments that have occurred since January 1, 2010:
•Axiron. We entered into an exclusive worldwide license agreement in the first quarter for the
commercialization of Acrux’s experimental testosterone solution Axiron, which the FDA approved in the fourth
quarter as a replacement therapy in men for certain conditions associated with a deficiency or absence of
testosterone. We, along with our partner Acrux, expect to launch Axiron in the U.S. by mid-2011.
•BI10773 and linagliptin. In January 2011, we announced a global agreement with Boehringer Ingelheim to
jointly develop and commercialize a portfolio of diabetes compounds currently in mid- and late-stage
development. Included are Boehringer Ingelheim’s two oral diabetes agents, linagliptin and BI10773, as well as
our two basal insulin analogues, LY2605541 and LY2963016, along with an option to co-develop and
co-commercialize Lilly’s anti-TGF-beta monoclonal antibody.
•Bydureon™—U.S. In October 2010, the FDA issued a complete response letter regarding the New Drug
Application (NDA) for Bydureon. In the complete response letter, the FDA requested a safety study to measure
the potential for heart rhythm disturbances when exenatide is used at higher-than-average doses. Additionally,
the FDA requested the results of the already completed DURATION-5 study to evaluate the efficacy, and the
labeling of the safety and effectiveness, of the commercial formulation of Bydureon. We, along with our partners
Amylin Pharmaceuticals, Inc. (Amylin) and Alkermes, Inc. (Alkermes), plan to submit our reply to the complete
response letter in the second half of 2011. Amylin received written feedback from the FDA indicating approval of
the study design for the required safety study to support the regulatory application. The study is expected to
begin in February. Based on the requirements for additional data, this will likely be considered a Class 2
resubmission requiring a six-month review.
•Bydureon—Europe. We, along with our partners Amylin and Alkermes, submitted Bydureon for review by the
European Medicines Agency in the first quarter of 2010.
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