Eli Lilly 2013 Annual Report Download - page 34

20
Late-Stage Pipeline
Our long-term success depends to a great extent on our ability to continue to discover and develop innovative
pharmaceutical products and acquire or collaborate on molecules currently in development by other
biotechnology or pharmaceutical companies. We currently have approximately 60 potential new drugs in
human testing or under regulatory review, and a larger number of projects in preclinical research.
The following new molecular entities (NMEs) have been submitted for regulatory review for potential use in
the disease described. The quarter the NME initially was submitted for any indication is shown in
parentheses:
Dulaglutide* (Q3 2013)—a long-acting analog of glucagon-like peptide 1 for the treatment of type 2
diabetes.
Empagliflozin (Q1 2013)—a sodium glucose co-transporter-2 (SGLT-2) inhibitor for the treatment of
type 2 diabetes (in collaboration with Boehringer Ingelheim).
New insulin glargine product (Q2 2013)—a new insulin glargine product for the treatment of type 1
and type 2 diabetes (in collaboration with Boehringer Ingelheim).
Ramucirumab* (Q3 2013)—an anti-vascular endothelial growth factor receptor-2 (VEGFR-2)
monoclonal antibody submitted for regulatory review as a single agent for the treatment of gastric
cancer. We intend to submit an application for ramucirumab in combination with paclitaxel for the
treatment of gastric cancer to regulatory authorities in 2014. We also intend to submit our first
application for ramucirumab in combination with chemotherapy (docetaxel) in patients with second-
line non-small cell lung cancer (NSCLC) to regulatory authorities in 2014. In addition, we are currently
studying ramucirumab in Phase III studies for the treatment of liver cancer and colorectal cancer.
The following NMEs are currently in Phase III clinical trial testing for potential use in the diseases described.
The quarter in which the NME initially entered Phase III for any indication is shown in parentheses:
Baricitinib (Q4 2012)—a Janus tyrosine kinase (JAK 1 and JAK 2) inhibitor for the treatment of
rheumatoid arthritis (in collaboration with Incyte Corporation).
Basal insulin peglispro (formerly known as novel basal insulin analog)* (Q4 2011)—a novel
basal insulin for the treatment of type 1 and type 2 diabetes.
Evacetrapib (Q4 2012)—a cholesteryl ester transfer protein (CETP) inhibitor for the treatment of
high-risk vascular disease.
Ixekizumab* (Q4 2011)—a neutralizing monoclonal antibody to interleukin-17A (IL-17) for the
treatment of psoriasis and psoriatic arthritis.
Necitumumab* (Q4 2009)—an anti-epidermal growth factor receptor (EGFR) monoclonal antibody
for the treatment of squamous NSCLC.
Solanezumab* (Q2 2009)—an anti-amyloid beta (Aß) monoclonal antibody for the treatment of mild
Alzheimer’s disease.
Tabalumab* (Q4 2010)—an anti-B-cell activating factor (BAFF) monoclonal antibody for the
treatment of systemic lupus erythematosus (lupus).
Tanezumab* (Q3 2008)—an anti-nerve growth factor monoclonal antibody for the treatment of
osteoarthritis pain, chronic low back pain and cancer pain (in collaboration with Pfizer Inc. (Pfizer)).
Tanezumab is currently subject to a partial clinical hold by the U.S. Food and Drug Administration
(FDA) (see Note 4 to the consolidated financial statements).
* Biologic molecule subject to the U.S. Biologics Price Competition and Innovation Act
The following are late-stage pipeline updates since January 1, 2013:
Basal insulin peglispro—In January 2013, we 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.